Tag: Business

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Business Technology

AM Best to host webinar on AM Best’s directors & officers insurance

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best will host a complimentary webinar on Thursday, May 27, 2021, at 2:00 p.m. (EDT). Sridhar Manyem and David Blades of AM Best will join industry experts to discuss emerging trends in the directors and officers insurance market. Topics covered will include rising litigation costs, a hardening pricing environment and the impact of special-purpose acquisition companies (SPAC), environmental, social and governance (ESG) and cyber for the market.

Register now: www.ambest.com/webinars/DO21.

Panelists include:

  • David Blades, associate director, AM Best;
  • Uri Dallal, managing director, AON;
  • Brian Finlay, senior vice president, Trans Re; and
  • Sridhar Manyem, director, industry research, AM Best.

Attendees can submit questions during registration or by emailing webinars@ambest.com. The event will be streamed in video and audio formats, and playback will be available to registered viewers shortly after the event.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2021 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey

Manager, Public Relations

+1 908 439 2200, ext. 5159

christopher.sharkey@ambest.com

Jim Peavy

Director, Communications

+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Categories
Business Science

Midwest Row Crop Collaborative receives $1.6 million HSBC Bank USA grant to help build a more resilient U.S. food system

Projects will support adoption of regenerative agriculture practices by U.S. farmers on more than 150,000 acres

NEW YORK & MINNEAPOLIS — (BUSINESS WIRE) — HSBC Bank USA, N.A., (HSBC) and the Midwest Row Crop Collaborative (MRCC) announced that HSBC has made a $1.6 million grant to MRCC to accelerate conservation and the adoption of regenerative practices such as cover crops, nutrient management, reduced tillage, and prairie strips on large-scale farms in MRCC’s collaborative projects.


Nature-based Solutions for Catalyzing a More Resilient U.S. Food System is the only U.S.-based project included as part of the Climate Solutions Partnership, which HSBC announced today. The Partnership aims to address barriers to scaling sustainable projects and to bring climate solutions to commercial viability, while also delivering for people and nature. Together with partners World Resources Institute (WRI) and World Wildlife Fund (WWF), the global initiative is backed by $100 million of philanthropic funding from HSBC over five years.

The U.S.-based work, driven by MRCC members Kellogg Company, PepsiCo, and The Nature Conservancy partnering with members Unilever and Cargill, is made possible through direct relationships with row crop farmers, in a region where row crops account for 75 percent of agricultural land. As farmers depend on healthy soil and water resources, which are being depleted rapidly, the benefits of regenerative practice adoption can offer a lifeline for individual farms over the long term. These practices protect against the flooding and erosion impacts of increasingly extreme weather, improve crop yields, and reduce production costs. “We had gullies and water collecting across parts of our land for some time, which prevented crops from being able to grow,” said Carter Morgan, a farmer participating in the Saving Tomorrow’s Agriculture Resources (STAR) initiative of Georgetown, Illinois. “Once we eliminated tillage and implemented cover crops, we got erosion under control, soil health improved, and our herbicide use went way down.”

The Climate Solutions Partnership is part of HSBC’s ambitious climate strategy. HSBC aims to align its provision of financing to net zero by 2050 or sooner, in line with the Paris Agreement goals, and to work across the financial sector and beyond to accelerate solutions that increase the pace of change.

The Partnership seeks to remove barriers and create incentives in three areas: energy transition, business innovation, and nature-based solutions. MRCC is part of the focus on nature-based solutions and will be one of 20 projects globally to protect and revitalize wetlands, mangroves and forests, and to promote sustainable agriculture. Working with a network of local partners, these projects will contribute to net-zero goals by capturing CO2 while increasing social and environmental resilience.

“HSBC’s new global Climate Solutions Partnership is about investing in tangible, high-potential methods to attack climate change, and there were no other efforts in the US that impressed us as much as the work being done by MRCC,” said Kelly Fisher, Head of Corporate Sustainability, HSBC USA. “These regenerative agriculture practices will help farmers to keep producing food in a meaningful and sustainable way long into the future.”

“Soil health is vital for both a healthy natural ecosystem and a healthy agricultural system that supports farm families and production of the food we eat. We are honored that our unique collaborative has been selected to advance the important work of restoring and maintaining soil health by building on our portfolio of projects across the Midwest.” said Margaret Henry, PepsiCo’s Director, Sustainable Agriculture.

Focused on Illinois, Iowa, Michigan, and Nebraska, the projects will expand practices that are transferrable to other growing regions in the Midwest, the U.S., and around the globe. Benefits of the work will be measured in multiple ways: reduced carbon emissions, improved water quality and biodiversity, enhanced food security by reducing soil loss, and improved farm profitability.

  • In Iowa and Nebraska, this grant will build on existing projects being implemented by Practical Farmers of Iowa to support expanding cover crops and introducing small grains to provide continuous living cover that protects and enhances soil health.
  • In Illinois, the Precision Conservation Management program implemented by the Illinois Corn Growers Association will be replicated in an entirely new region, expanding its impact to 100 additional farms over four years. A pay-for-performance model to provide growers conservation practice adoption incentives by utilizing the STAR initiative will also be implemented in Illinois.
  • In Michigan, MRCC will develop a sustainably grown grain pilot program that can be incorporated into supply partners’ buying frameworks, with the potential to link conservation incentives to the point of sale. Carrie Vollmer-Sanders, farmer, Agriculture Engagement Strategy Director at The Nature Conservancy, and MRCC co-chair offers that “on-farm practices benefitting the environment and society without a visible financial payoff for 3-5 years are difficult practices to embrace. This grant will allow us to prove out the financial benefit and break down some of the barriers to adopting regenerative practices.”

A unique aspect of the Climate Solutions Partnership will be the creation of a Nature-based Solutions Accelerator, facilitated by global partners WRI and WWF, which will highlight meaningful innovations, including MRCC’s work in Illinois, Iowa, Michigan, and Nebraska.

Another unique aspect is that, during the four-year grant term, participating projects may draw upon additional expertise from other MRCC members, including Bayer, Environmental Defense Fund, Walmart, and WWF. MRCC members represent distinct roles in the food and agriculture value chain, which creates an opportunity to drive collective action and remove barriers for systemic change to improve food system health, environmental outcomes, and the well-being of farmers.

“We firmly believe that partnering with farmers – with support from trusted networks, technical assistance, and funding partnerships to weather their first few years of transition to regenerative practices – is an investment in healthy soils that are the foundation for a resilient future for Midwest agriculture,” said Kate Schaffner, Global Sustainability Manager, Kellogg Company. “We‘re proud to continue our long-standing partnership with MRCC and this important work as it supports Kellogg’s Better Days commitment to support one million farmers by the end of 2030.”

Fourth generation wheat farmer Mike Milligan, a participant in Kellogg’s and The Nature Conservancy’s project in the Saginaw Bay region of Michigan, echoes the same sentiment, saying “we are here to build something longer term than one lifespan.”

Note to editors:

Midwest Row Crop Collaborative

Administered by Environmental Initiative, the Midwest Row Crop Collaborative explores new approaches to agricultural challenges to find solutions that increase productivity while ensuring soil health, protecting water, addressing the factors contributing to climate change, and supporting farm families. Members include Bayer, Cargill, Environmental Defense Fund, Kellogg Company, PepsiCo, The Nature Conservancy, Unilever, Walmart, and World Wildlife Fund.

HSBC

HSBC Bank USA, National Association (HSBC Bank USA, N.A.) serves customers through retail banking and wealth management, commercial banking, private banking, and global banking and markets segments. It operates bank branches in: California; Washington, D.C.; Florida; Maryland; New Jersey; New York; Pennsylvania; Virginia; and Washington. HSBC Bank USA, N.A. is the principal subsidiary of HSBC USA Inc., a wholly owned subsidiary of HSBC North America Holdings Inc. In the United States, deposit products are offered by HSBC Bank USA, N.A., Member FDIC, investment and brokerage services are provided through HSBC Securities (USA) Inc., (Member NYSE/FINRA/SIPC) and insurance products are provided through HSBC Insurance Agency (USA) Inc.

HSBC Holdings plc, the parent company of the HSBC Group, is headquartered in London. HSBC serves customers worldwide from offices in 64 countries and territories in its geographical regions: Europe, Asia, North America, Latin America, and Middle East and North Africa. With assets of $2,959bn at 31 March 2021, HSBC is one of the world’s largest banking and financial services organizations.

Contacts

MRCC media contact: Deborah Carter McCoy, 651-707-6254, dcartermccoy@ei-in.org
HSBC media contact: Rob Sherman, 646-939-6998, robert.a.sherman@us.hsbc.com

Categories
Healthcare Science

Long-term data on Vitrakvi® (larotrectinib) further demonstrate strong clinical profile in patients with TRK fusion cancer regardless of tumor type and age

  • Vitrakvi® (larotrectinib) achieved 75% (95% CI 68-81) overall response rate (ORR) and median duration of response (DoR) of 49.3 months (95% CI 27.3-not estimable [NE]) in expanded integrated dataset of 206 evaluable adults and children with TRK fusion cancer, across 21 different tumor types and regardless of age (range: 0.1-84 years) with a median follow-up of 22.3 months
  • New findings in an expanded lung cancer data subset show consistent ORR, and additional results from subset of patients with primary central nervous system (CNS) tumors were presented
  • A retrospective intra-patient comparison of growth modulation index (GMI) data was presented
  • In the integrated dataset, majority of adverse events (AEs) were Grade 1 or 2 and no new safety signals were identified

Abstracts: 3108, 9109, 2002, 3114

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer to present new data across four distinct analyses showcasing the consistent, long-term clinical profile for Vitrakvi® (larotrectinib) across TRK fusion cancer patients of all ages (range: 0.1-84 years) and multiple tumor types. The analyses include updated long-term efficacy and safety data across solid tumors, including primary central nervous system (CNS) tumors and lung cancer, harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. In addition, an intra-patient pooled retrospective analysis assessing the treatment effect of Vitrakvi in patients with TRK fusion cancer previously treated with one or more line of therapy were presented. These analyses add to the existing clinical profile for Vitrakvi, which has the largest dataset and longest follow-up of any TRK inhibitor, at median follow-up of 22.3 months, for patients across all ages and tumor types with an NTRK gene fusion. These findings are being presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held online June 4-8, 2021.

 

Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Patients should be selected for therapy based on a Food and Drug Administration (FDA)-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1

 

“This data adds to larotrectinib’s growing clinical profile, supporting its use as an effective treatment option for adults and children with NTRK gene fusion positive tumors,” said David S. Hong, M.D., Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “These findings present a clear rationale for robust comprehensive genomic testing inclusive of NTRK 1/2/3 genes for patients to better understand what could be driving their cancer and appropriately match them with the right treatment approach.”

 

“Designed specifically to treat TRK fusion cancer, Vitrakvi represents a meaningful advancement in the treatment of both adult and pediatric patients with TRK fusion cancer, inhibiting the oncogenic driver that causes these tumors to spread and grow, regardless of where they originate in the body,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “These long-term data reinforce the use of Vitrakvi for patients with TRK fusion cancer and demonstrate our commitment to advancing the future of cancer care and providing true value for patients and physicians.”

 

Vitrakvi adult and pediatric integrated dataset (Abstract 3108)2

An expanded dataset with longer follow-up (cut-off July 20, 2020) with 206 evaluable adult and pediatric patients with TRK fusion cancer across 21 different tumor types showed an overall response rate (ORR) per investigator assessment of 75% (95% CI 68-81), including 22% complete responses (n=45). For evaluable patients with brain metastases (n=15), the ORR was 73% (95% CI 45-92). Among all evaluable patients, the median duration of response (DoR) was 49.3 months (95% CI 27.3-NE) at a median follow-up of 22.3 months. Data on progression-free survival (PFS) and overall survival (OS) in this expanded dataset were also presented.

 

No new safety signals were identified. The majority of treatment-related adverse events (TRAEs) reported were primarily Grade 1 or 2, with 18% of patients reporting Grade 3 or 4 TRAEs. Two percent of patients discontinued Vitrakvi due to TRAEs and no treatment-related deaths were reported.

 

Data for the integrated dataset were pooled from three Vitrakvi clinical trials (NCT02122913, NCT02576431 and NCT02637687) in adult and pediatric patients with TRK fusion cancer. This analysis did not include the primary CNS patient subset.

 

Vitrakvi in lung cancer with or without CNS metastases (Abstract 9109)3

Updated data (cut-off July 20, 2020) on heavily pre-treated adult TRK fusion cancer patients with lung cancer, who had received a median of three prior therapies, showed Vitrakvi demonstrated consistent response rates with longer follow-up. Among 15 evaluable patients and based on investigator assessment, the confirmed ORR was 73% (95% CI 45-92), and among evaluable patients with baseline CNS metastases (n=8), the ORR was 63% (95% CI 25-91). In all evaluable patients (n=15), the 12-month rate for DoR was 81%. Data on PFS and median OS in this data subset were also presented. TRAEs were reported in 16 patients, of which two patients experienced Grade 3 events. No patients discontinued Vitrakvi due to TRAEs. These data were investigator-assessed and from patients enrolled in two clinical trials (NCT02576431, NCT02122913).

 

Vitrakvi in primary CNS tumors (Abstract 2002)4

In another presentation (cut-off July 20, 2020) Vitrakvi was assessed in 33 pediatric and adult patients with primary CNS tumors with an NTRK gene fusion, pooled from two clinical trials (NCT02637687, NCT02576431).The majority of patients (82%) with measurable disease experienced tumor shrinkage with an ORR of 30% (CI 95% 16-49). The 24-week disease control rate was 73% (95% CI 54-87). Data on PFS and median OS in this data subset were also presented. Grade 3 or 4 TRAEs occurred in three patients. No patients discontinued Vitrakvi due to TRAEs.

 

Intra-patient comparison from Vitrakvi clinical trials in TRK fusion cancer (Abstract 3114)5

Additional Vitrakvi data presented at the congress include an updated and extended retrospective growth modulation index (GMI) analysis limited to patients enrolled in Vitrakvi trials with at least one prior line of therapy. GMI is a retrospective intra-patient comparison that uses the patient as their own control by comparing PFS on current therapy to time to progression or treatment failure (TTP) on the most recent prior therapy. A GMI ratio ≥ 1.33 has been used as a threshold for meaningful clinical activity.

 

About Vitrakvi® (larotrectinib)

Vitrakvi® (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

 

Select patients for therapy based on an FDA-approved test.

 

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

Important Safety Information for Vitrakvi® (larotrectinib)

Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood disorders, and sleep disturbances.

 

In patients who received VITRAKVI, all grades CNS effects including cognitive impairment, mood disorders, dizziness and sleep disorders were observed in 42% with Grades 3-4 in 3.9% of patients.

 

Cognitive impairment occurred in 11% of patients. The median time to onset of cognitive impairment was 5.6 months (range: 2 days to 41 months). Cognitive impairment occurring in ≥ 1% of patients included memory impairment (3.6%), confusional state (2.9%), disturbance in attention (2.9%), delirium (2.2%), cognitive disorders (1.4%), and Grade 3 cognitive adverse reactions occurred in 2.5% of patients. Among the 30 patients with cognitive impairment, 7% required a dose modification and 20% required dose interruption.

 

Mood disorders occurred in 14% of patients. The median time to onset of mood disorders was 3.9 months (range: 1 day to 40.5 months). Mood disorders occurring in ≥1% of patients included anxiety (5%), depression (3.9%), agitation (2.9%), and irritability (2.9%). Grade 3 mood disorders occurred in 0.4% of patients.

 

Dizziness occurred in 27% of patients, and Grade 3 dizziness occurred in 1.1% of patients. Among the 74 patients who experienced dizziness, 5% of patients required a dose modification and 5% required dose interruption.

 

Sleep disturbances occurred in 10% of patients. Sleep disturbances included insomnia (7%), somnolence (2.5%), and sleep disorder (0.4%). There were no Grade 3-4 sleep disturbances. Among the 28 patients who experienced sleep disturbances, 1 patient each (3.6%) required a dose modification or dose interruption.

 

Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.

 

Skeletal Fractures: Among 187 adult patients who received VITRAKVI across clinical trials, fractures were reported in 7% and among 92 pediatric patients, fractures were reported in 9% (N=279; 8%). Median time to fracture was 11.6 months (range 0.9 to 45.8 months) in patients followed per fracture. Fractures of the femur, hip or acetabulum were reported in 4 patients (3 adult, 1 pediatric). Most fractures were associated with minimal or moderate trauma. Some fractures were associated with radiologic abnormalities suggestive of local tumor involvement. VITRAKVI treatment was interrupted due to fracture in 1.4% patients.

 

Promptly evaluate patients with signs or symptoms of potential fracture (e.g., pain, changes in mobility, deformity). There are no data on the effects of VITRAKVI on healing of known fractures or risk of future fractures.

 

Hepatotoxicity: In patients who received VITRAKVI, increased AST of any grade occurred in 52% of patients and increased ALT of any grade occurred in 45%. Grade 3-4 increased AST or ALT occurred in 3.1% and 2.5% of patients, respectively. The median time to onset of increased AST was 2.1 months (range: 1 day to 4.3 years). The median time to onset of increased ALT was 2.3 months (range: 1 day to 4.2 years). Increased AST and ALT leading to dose modifications occurred in 1.4% and 2.2% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 3 (1.1%) of patients.

 

Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.

 

Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.

 

Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%), including laboratory abnormalities, were: increased AST (52%), increased ALT (45%), anemia (42%), musculoskeletal pain (42%), fatigue (36%), hypoalbuminemia (36%), neutropenia (36%), increased alkaline phosphatase (34%), cough (32%), leukopenia (28%), constipation (27%), diarrhea (27%), dizziness (27%), hypocalcemia (25%), nausea (25%), vomiting (25%), pyrexia (24%), lymphopenia (22%) and abdominal pain (21%).

 

Drug Interactions: Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.

 

Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.

Please see the full Prescribing Information for VITRAKVI® (larotrectinib).

 

About TRK Fusion Cancer

TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including lung, thyroid, GI cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (secretory carcinoma of the salivary gland) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma).1,6

 

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

© 2021 Bayer

BAYER, the Bayer Cross, and Vitrakvi are registered trademarks of Bayer.

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

References

1. Vitrakvi® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; March 2021.

2. Hong, et al. Long-term efficacy and safety of larotrectinib in an integrated dataset of patients with TRK fusion cancer [abstract]. In: ASCO Meeting Library: ASCO; 2021. Abstract 3108.

3. Lin, et al. Long-term efficacy and safety of larotrectinib in patients with TRK fusion-positive lung cancer [abstract]. In: ASCO Meeting Library: ASCO; 2021. Abstract 9109.

4. Perreault, et al. Efficacy and safety of larotrectinib in adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion-positive primary central nervous system (CNS) tumors [abstract]. In: ASCO Meeting Library: ASCO; 2021. Abstract 2002.

5. Italiano, et al. Intra-patient comparison from larotrectinib clinical trials in TRK fusion cancer – an expanded dataset [abstract]. In: ASCO Meeting Library: ASCO; 2021. Abstract 3114.

6. Vaishnavi A, Le AT, Doebele RC. TRKing down an old oncogene in a new era of targeted therapy. Cancer Discov. 2015;5(1):25-34.

PP-VIT-US-0761-1

Intended for US Media Only

Contacts

Media:
Rose Talarico, Tel. +1 862.404.5302

E-Mail: rose.talarico@bayer.com

Categories
Local News Science

Four-year data from Phase 3 CheckMate -227 trial show durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) in Patients with Non-Small Cell Lung Cancer with PD-L1 Expression ≥1%

Opdivo plus Yervoy continues to demonstrate a clinically meaningful survival benefit vs. chemotherapy with the longest follow-up of any Phase 3 trial for an immunotherapy combination in non-small cell lung cancer

Increased overall survival and improvements in key secondary endpoints observed at four years in the primary population of patients whose tumors express PD-L1 ≥1%

In exploratory analyses of patients with PD-L1 expression <1%, Opdivo plus Yervoy more than doubled four-year survival vs. chemotherapy

Data to be presented during the 2021 American Society of Clinical Oncology Annual Meeting

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO21—Bristol Myers Squibb (NYSE: BMY) today announced that Part 1 of the Phase 3 CheckMate -227 trial continues to demonstrate the long-term survival benefits of first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), regardless of PD-L1 expression level or histology, with a minimum follow-up of over four years (49.4 months):

  • In the primary population of patients with PD-L1 expression ≥1%, the four-year survival rate for Opdivo plus Yervoy was 29%, compared to 18% for chemotherapy (Hazard Ratio [HR] 0.76; 95% Confidence Interval [CI]: 0.65 to 0.90).
  • In an exploratory analysis of patients with PD-L1 expression <1%, more than twice as many patients treated with Opdivo plus Yervoy were alive at four years compared to chemotherapy (24% vs. 10%, respectively; HR 0.64; 95% CI: 0.51 to 0.81).

The safety profile for the dual immunotherapy combination remained consistent with previously reported data in NSCLC and was manageable with established protocols, with no new safety signals identified. The full data will be presented in a poster discussion session (Abstract #9016), available on June 4, 2021 at 9:00 a.m. EDT during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

“As clinicians, our aim in treating lung cancer is to extend the lives of patients with this disease, which remains the leading cause of cancer deaths,” said Luis G. Paz-Ares, M.D., Ph.D., chair of the medical oncology department, Hospital Universitario 12 De Octubre. “In CheckMate -227, nivolumab plus ipilimumab continues to demonstrate durable overall survival as well as impressive duration of response after four years of follow-up. These data illustrate how much progress we have made in addressing advanced non-small cell lung cancer and reinforce the importance of this dual immunotherapy regimen among first-line options.”

In exploratory, descriptive analyses of patients whose tumors express PD-L1, including in those with PD-L1 expression ≥50%, the combination of Opdivo plus Yervoy showed efficacy benefits relative to Opdivo monotherapy at four years, reinforcing the importance of Yervoy for improving long-term outcomes:

  • In patients with PD-L1 expression ≥1%, 29% of patients treated with Opdivo plus Yervoy were alive, relative to 21% with Opdivo monotherapy.
  • In patients with high PD-L1 expression (≥50%), 37% of Opdivo plus Yervoy patients were alive, relative to 26% for Opdivo alone.

Similarly, in exploratory, descriptive analyses of patients with PD-L1 expression <1%, Opdivo plus Yervoy was associated with an overall survival (OS) benefit relative to Opdivo plus chemotherapy, with four-year OS rates of 24% and 13%, respectively.

Patients in the study treated with Opdivo plus Yervoy also achieved more durable responses than those treated with chemotherapy. These responses continued after patients stopped treatment, which ended at a maximum of two years according to the trial protocol:

  • In patients with PD-L1 expression ≥1% who responded to Opdivo plus Yervoy, more than one third (34%) remained in response at four years, compared to 7% with chemotherapy.
  • In patients with PD-L1 expression <1%, 31% of Opdivo plus Yervoy responders remained in response vs. 0% with chemotherapy.

“With each additional year of follow-up, we continue to see the sustained benefits of the Opdivo plus Yervoy combination, not only in lung cancer, but in several different tumor types. The four-year results from CheckMate -227, showing improved long-term outcomes with Opdivo plus Yervoy, are the most mature Phase 3 data for an immunotherapy combination in first-line advanced non-small cell lung cancer,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “We thank the patients and investigators involved in the trial, who have made it possible to bring the proven benefit of dual immunotherapy to people living with non-small cell lung cancer around the world.”

Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials to date: CheckMate -227 and CheckMate -9LA in NSCLC, CheckMate -067 in metastatic melanoma, CheckMate -214 in advanced renal cell carcinoma, CheckMate -743 in malignant pleural mesothelioma and CheckMate -648 in esophageal squamous cell carcinoma.

About CheckMate -227

CheckMate -227 is a multi-part open-label Phase 3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC) across non-squamous and squamous tumor histologies.

There are two primary endpoints in Part 1 for Opdivo plus Yervoy (versus chemotherapy): overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a) and progression-free survival (PFS) in patients with tumor mutational burden (TMB) ≥10 mutations/megabase (mut/mb) across the PD-L1 spectrum (assessed in patients enrolled across Parts 1a and 1b). Patients were dosed as follows:

  • Part 1a: Opdivo (3 mg/kg every 2 weeks) plus Yervoy (1 mg/kg every 6 weeks) or Opdivo monotherapy (240 mg every 2 weeks) versus chemotherapy (every 3 weeks for up to four cycles) in patients whose tumors express PD-L1 (≥1%)
  • Part 1b: Opdivo plus Yervoy or Opdivo (360 mg every 3 weeks) plus chemotherapy (every 3 weeks for up to four cycles) versus chemotherapy (every 3 weeks for up to four cycles) in patients whose tumors do not express PD-L1 (<1%)

Part 1 met both its co-primary endpoints of PFS with the Opdivo plus Yervoy combination versus chemotherapy in patients whose tumors have high (≥10 mut/mb) TMB, regardless of PD-L1 expression, and OS demonstrating a superior benefit for Opdivo plus Yervoy versus chemotherapy in first-line NSCLC patients whose tumors expressed PD-L1 ≥1%.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic NSCLC, the five-year relative survival rate is approximately 6%.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

Indications

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Important Safety Information

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY . Early identification and management are essential to ensure safe use of OPDIVO and YERVOY . Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY . In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis , which may be fatal . A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%) and Grade 2 (5%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO monotherapy in Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients. In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%) and Grade 2 (2.5%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.

Contacts

Bristol Myers Squibb

Media Inquiries:
Media@BMS.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

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Categories
Business Technology

Samsung unveils National Winners in $2 Million STEM competition for innovations that Address urban sustainability, social justice and isolation-induced depression amid COVID-19

 

 

Schools in Michigan, Pennsylvania and Texas recognized for tackling pressing issues in 11th annual Samsung Solve for Tomorrow Contest

 

RIDGEFIELD PARK, N.J. — (BUSINESS WIRE) — Samsung Electronics America, Inc. announced today the three grand prize National Winners in the 11th annual Samsung Solve for Tomorrow Contest – a $2 million* national competition that challenges public school students in grades 6-12 to use STEM (science, technology, engineering and math) skills to address real-world change in their communities. Revealed during a livestream virtual celebration event, each National Winner school will receive $130,000 in technology and supplies to meet the needs of their classrooms.

 

Three National Winners were selected following a virtual pitch event where students presented their STEM projects to a panel of judges. From urban sustainability to social justice and isolation-induced depression from COVID-19, each National Winner used problem-based learning to respond to an issue of national importance impacting their local communities. Throughout the academic school year – while learning in virtual and hybrid environments – students and teachers forged new pathways using creativity and innovation to create their STEM solutions.

 

“We are in awe of the resilient, bright young minds who remained nimble despite a challenging school year. Met with virtual and hybrid learning environments, their ability to empathetically approach three of the most critical issues facing our society and each transform an idea into a STEM innovation is nothing short of incredible,” said Ann Woo, Senior Director of Corporate Citizenship at Samsung Electronics America. “Tackling social justice, the pandemic and health of our planet, these are the problem-solvers and changemakers who build hope for our future.”

 

The three National Winners in the 11th annual Samsung Solve for Tomorrow Contest and their grand prize-winning STEM innovations are:

 

1. Hope of Detroit Academy – Detroit, Michigan

The student’s local community in southwest Detroit faces excessive amounts of garbage, used tires left in open spaces and unsecured abandoned homes. In Detroit, a significant percentage of housing parcels in the city are vacant, and abandoned lots are prevalent throughout residential areas. The students created an app – the Green Warrior – that tracks these sites and reports them to local community organizations that help lead clean-up efforts. For example, Green Tree Plastics will help collect plastic from abandoned sites and convert it into park benches, and Cass Community Social Services will help pick up and recycle tires.

View Hope of Detroit Academy’s project video here: https://youtu.be/hfY23Gzbmek

 

2. Northwest Pennsylvania Collegiate Academy – Erie, Pennsylvania

After witnessing recent events locally and nationally where people were challenged while advocating for social justice, the students recognize that many people fear encounters with law enforcement during protests, rallies or traffic stops. Wanting to be allies and protect the civil rights of people using their voice in potentially threatening situations, the students created a voice-activated mobile app that turns the phone into a body camera or dash cam to record the events and interactions.

In addition to being named a National Winner, Northwest Pennsylvania Collegiate Academy has also been named the Samsung Employee Choice Award Winner,winning an additional $15,000.

View Northwest Pennsylvania Collegiate Academy’s project video here: https://youtu.be/bqrckcWFrjk

 

3. Porter High School – Porter, Texas

As many as one in four elderly individuals report having anxiety or depression amid the COVID-19 pandemic, and a study by the CDC showed that isolation and loneliness are associated with a 50% increased risk of developing dementia, a 32% increased risk of stroke, and a nearly fourfold increased risk of death among heart failure patients. To combat isolation-induced depression and loneliness, students created an app-website combo, Gen-Bridge, that enables students and others to connect in various ways – including video calls, games and more – with seniors residing in assisted living facilities.

 

View Porter High School’s project video here: https://youtu.be/camCTwrC2EY

 

Students and teachers from each National Winner school have met with local representatives to discuss their respective projects.

 

In addition to the three National Winners, Tulare Union High School in Tulare, California, and Tucker Middle School in Tucker, Georgia, were named Community Choice Winners for generating the most social media votes for their inventions addressing traffic collisions and human trafficking, respectively. These two schools will each receive an additional $15,000 in technology on top of $65,000 in technology for being named National Finalists in this year’s competition.

 

The three National Winners, two Community Choice Award Winners and Samsung Employee Choice Award Winner were revealed in a virtual celebration event, which brought together dozens of students and teachers from the 10 National Finalist schools. The event included remarks from Samsung executives and employee mentors as well as Solve for Tomorrow alumni and can be seen here. The event also included a guest appearance by artist and animator, Danny Casale.

 

Anchored in Samsung’s guiding vision of ‘Together for Tomorrow! Enabling People’, Solve for Tomorrow launched in 2010 to encourage innovative thinking, creative problem-solving and teamwork to discover and nurture social innovation ideas aimed at resolving society’s most pressing problems. What began as an environment-focused essay contest has transformed into a problem-based learning initiative that fosters critical thinking and creative problem solving. Since its inception, the Samsung Solve for Tomorrow Contest has awarded $18 million in Samsung technology and classroom materials to more than 2,500 public schools in the United States.

 

To learn more about the contest and this year’s winners, please visit: ​www.samsung.com/solve or follow us at on Instagram @solvefortomorrow. For official rules and judging criteria, click here.

 

*Prize is based on an estimated retail value. | Not open to the general public: No purchase necessary to enter or win. Open to employees at eligible schools in the fifty (50) United States/DC twenty-one (21) years of age or older. To enter/official rules: visit www.Samsung.com/Solve to complete the application form. | The school is responsible for ensuring the proper handling and security of all data potentially shared and/or collected as part of their project. Samsung takes privacy very seriously and encourages all Semi-Finalists to consider how information that is part of their project is being handled. | The school is responsible for ensuring safety, security, bias and privacy matters related to artificial intelligence (AI) as part of their project. Samsung takes privacy very seriously and encourages all Semi-Finalists to consider all safety precautions related to their projects throughout development.

 

About Samsung Electronics America, Inc.

Headquartered in Ridgefield Park, N.J., Samsung Electronics America, Inc. (SEA), is a leader in mobile technologies, consumer electronics, home appliances and enterprise solutions. A wholly owned subsidiary of Samsung Electronics Co., Ltd., SEA is pushing beyond the limits of today’s technology and providing consumers and organizations with a portfolio of groundbreaking products and services across mobile devices, connected appliances, home entertainment, 5G networks and digital solutions. To discover more about Samsung, please visit www.samsung.com. For the latest Samsung News please visit news.samsung.com/us and follow us @SamsungNewsUS.

Contacts

Olivia Gust

Allison+Partners for Samsung

1-503-528-6768

SamsungSFT@allisonpr.com

Categories
Business Technology

NICE Enlighten AI recognized with Product of the Year Award for enabling organizations to meet and exceed next-gen customer expectations

CUSTOMER Magazine honors NICE Enlighten AI as an innovative CX solution and highlights dedication to quality that benefits the overall customer experience while driving ROI

 

HOBOKEN, N.J. — (BUSINESS WIRE) — #NICE—NICE (Nasdaq: NICE) today announced that NICE Enlighten AI for Customer Satisfaction has been named a winner of the 2021 CUSTOMER Magazine Product of the Year Award by integrated media company TMC. Highlighting products that enable their clients to meet and exceed customers’ expectations, the award recognizes organizations that are advancing the call center, CRM and teleservices industries one solution at a time.

Barry Cooper, President, NICE Workforce and Customer Experience Group, said, “We are in the business of empowering organizations to boost brand loyalty by enabling every customer’s experience to be personalized and contextual. As organizations prioritize the delivery of next-gen CX, we’re proud to shine a light on how embedding smart AI everywhere helps measurably boost customer satisfaction and employee engagement.”

NICE Enlighten AI for Customer Satisfaction enables businesses of all sizes to proactively make every customer interaction exceptional. NICE Enlighten AI interprets and objectively measures the human behaviors proven to influence customer satisfaction. Out of the box Enlighten AI behavior models accurately and immediately score nine specific agent behaviors, such as demonstrating ownership, being empathetic, questioning effectively and more, as well as customer sentiment on every interaction and presents them on the agent and manager’s dashboards. As a result, agents can proactively adapt and self-improve their behavior in real-time while managers can identify coaching opportunities to drive longer term development.

About NICE

NICE (Nasdaq: NICE) is the world’s leading provider of both cloud and on-premises enterprise software solutions that empower organizations to make smarter decisions based on advanced analytics of structured and unstructured data. NICE helps organizations of all sizes deliver better customer service, ensure compliance, combat fraud and safeguard citizens. Over 25,000 organizations in more than 150 countries, including over 85 of the Fortune 100 companies, are using NICE solutions. www.nice.com.

Trademark Note: NICE and the NICE logo are trademarks or registered trademarks of NICE Ltd. All other marks are trademarks of their respective owners. For a full list of NICE’s marks, please see: www.nice.com/nice-trademarks.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including the statements by Mr. Cooper, are based on the current beliefs, expectations and assumptions of the management of NICE Ltd. (the “Company”). In some cases, such forward-looking statements can be identified by terms such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” “estimate,” or similar words. Forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results or performance of the Company to differ materially from those described herein, including but not limited to the impact of changes in economic and business conditions, including as a result of the COVID-19 pandemic; competition; successful execution of the Company’s growth strategy; success and growth of the Company’s cloud Software-as-a-Service business; changes in technology and market requirements; decline in demand for the Company’s products; inability to timely develop and introduce new technologies, products and applications; difficulties or delays in absorbing and integrating acquired operations, products, technologies and personnel; loss of market share; an inability to maintain certain marketing and distribution arrangements; the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners;, cyber security attacks or other security breaches against the Company; the effect of newly enacted or modified laws, regulation or standards on the Company and our products and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”). For a more detailed description of the risk factors and uncertainties affecting the company, refer to the Company’s reports filed from time to time with the SEC, including the Company’s Annual Report on Form 20-F. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contacts

Corporate Media Contact
Christopher Irwin-Dudek, +1 201 561 4442, ET, chris.irwin-dudek@nice.com

Investors
Marty Cohen, +1 551 256 5354, ET, ir@nice.com

Categories
Business

Barrie House Coffee Roasters expands in-store presence with retailers in New York and New Jersey

Gristedes, D’Agostino, Morton Williams, Foodtown, And Key Food Are Among the Key Retailers to Showcase New Product Launch and Rebranding

 

ELMSFORD, N.Y. — (BUSINESS WIRE) — #BarrieHouse—Barrie House Coffee Roasters, a family-owned coffee roaster that produces premium, fair trade, organic coffee, has recently expanded distribution in the New York Metro area, specifically in NYC, Long Island and Westchester County, as well as Northern New Jersey. Following the success of their product line launch and rebranding in September 2020, grocery retailers including Gristedes, D’Agostino, Morton Williams, Foodtown, and Key Food are carrying the new Barrie House Coffee line either chainwide or in select stores. Barrie House products can also be found in a number of independent, natural, and specialty retailers throughout the Tri-State area.

“After completing the Barrie House rebranding and product launch this past year, our team is very excited to see the new products stocked on the shelves of these retailers,” said John C. Fallon, Chief Marketing Officer of Barrie House Coffee Roasters. “Our goal is to make Barrie House the go-to choice for sustainably sourced, Fair Trade and Organic coffee at a reasonable price.”

 

Barrie House’s partnership with these retailers is a big step forward as the company establishes the brand in the New York City area – its own backyard. All of these retailers align with the Barrie House brand in that they are popular mainstays in the New York Metro area, are privately and/or independently owned, and provide a customer experience focused on quality and value.

 

Barrie House’s new product line offers a wide selection of coffees across three distinctive collections: The Estate Blends, Signature Flavors, and Single Origins. These coffees are available in 10 oz. and 2 lb. bags, as well as 10 count and 24 count single-serve capsules that are Keurig 2.0 compatible. In addition to being sold in-store, the line is available online at Barriehouse.com, as well as many other online sites including Amazon, SamsClub.com, Walmart.com, FreshDirect, and more. Photo Link.

 

“We want to thank these signature metro New York retailers for their partnership and support as well as our distribution partners UNFI, KEHE, and BCS Royal for executing this new distribution,” said Michele Abo, Chief Sales Officer, Barrie House Coffee Roasters. “We are also excited about growing our food service business with our new coffees and are thrilled to have our new partners Ammirati Coffee and Whole Latte Love join our existing network of great distributors in these efforts.”

 

For more information or to find a location near you that sells Barrie House coffee, use the Store Locator at BarrieHouse.com.

 

About Barrie House Coffee Roasters:

Founded in 1934 outside of New York City, Barrie House is a family-owned coffee roaster that produces premium, handcrafted coffee. For over 85 years, Barrie House Coffee Roasters have carefully selected, blended, roasted, and packed what they believe to be the world’s finest coffee. Today, Barrie House is a leading roaster and manufacturer for private label and branded coffee products sold through the retail, e-commerce, food service, and hospitality channels. Barrie House has partnered with Martha Stewart for a co-branded coffee line and with The Headstrong Project for a special Heroes Reserve line of which 100% of the profits are donated to the organization. They rank in the Top 10 of all Fair Trade coffee providers in the U.S.

Stay updated on all Barrie House news by following us @BarrieHouseCoffee on Instagram and Facebook.

Contacts

Christina Rae

Buzz Creators, Inc.

(914) 610-8558

crae@buzz-creators.com

Categories
Business Technology

Precision Spine® reaches milestone with the Reform® Modular Pedicle Screw System

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — The Reform® Modular Pedicle Screw System, first introduced by Precision Spine in April 2016, today reaches a monumental milepost, its 30,000th modular screw implantation. This historic milestone is most impressive when highlighted by the fact that there have been no reported dissociations to date.

 

The Reform® Modular Pedicle Screw System provides surgeons with increased flexibility, versatility, and visibility to meet the varying requirements of degenerative and trauma procedures. The cobalt chrome and titanium tulips are available in both 5.5 and 4.75mm sizes, with standard and reduction options. The system features Tru-Lock Technology that allows the tulip to be attached with a consistent attachment force, as well as a helpful audible click and tactile feel to confirm attachment. The titanium modular cannulated and non-cannulated screws feature a minimally tapered, triple lead thread, as well as a self-starting aggressive screw tip and enlarged T25 drive feature ─ the combination of which delivers more immediate, secure bone engagement and maximum control during insertion. The system’s modularity is intended to help increase the surgeon’s visibility in order to permit more thorough decortication of the surrounding fusion bed. A full complement of offset connectors, dominoes, hooks, and cross connectors increases procedure flexibility.

 

“The system’s modular design greatly enhances O.R. versatility and efficiency,” said Vikram Udani, M.D., “assisting surgeons with intraoperatively assembling a construct that achieves immediate bone purchase, with a pull-out strength that provides optimal security.”

 

“We are pleased and proud to document this event in our company annals,” said Chris DeNicola, the company’s Chief Operating Officer, “as it is further evidence of our continuing mission to provide patients and surgeons worldwide with safe and effective solutions for complex spinal pathologies. We view this milestone as validation of the great trust placed in the company by our distribution partners and the surgeons they serve and support.”

 

About Precision Spine

Precision Spine, Inc. is a privately held company headquartered in Parsippany, NJ, with manufacturing facilities in Pearl, MS. Precision Spine is dedicated to providing innovative, quality spine products that are made in the USA, and designed to help treat serious orthopedic medical conditions in a cost-effective manner. For more information, visit www.precisionspineinc.com.

Contacts

Chris DeNicola, Chief Operating Officer: chris.denicola@precisionspineinc.com

Categories
Business

Spinnaker Insurance Company names Risk Veteran Torben Ostergaard as CEO

Ostergaard joins from USAA, where he served as executive vice president and chief risk officer, and will strengthen Spinnaker’s position as a best-in-class fronting carrier with the backing of parent company Hippo’s technology

Former CEO Dave Ingrey, will transition to chief operating officer, a critical role as the company scales to new categories by utilizing innovative technology, data and analytics to deliver industry leading services

 

BEDMINSTER, N.J. — (BUSINESS WIRE) — Spinnaker Insurance Company, a national property and casualty insurer licensed in 50 states and rated A- (Excellent) by A.M. Best Company, wholly owned by Hippo Enterprises Inc., today announced the appointment of Torben Ostergaard as its new president and chief executive officer. Ostergaard joins Spinnaker after more than a decade in c-suite roles at insurance and financial services firm USAA. Dave Ingrey, who previously held the CEO position, will transition to chief operating officer and continue to play an integral role in shaping Spinnaker’s future.

Most recently a Fortune 100 executive, Ostergaard brings 25 years’ experience as a risk officer working across the financial services industry. At USAA, he served as executive vice president, chief risk officer and a member of the executive council that manages the day-to-day operations of the company, including property & casualty insurance, banking and life insurance. Prior to USAA, he was chief credit officer at HSBC Financial in Canada. He is currently serving on Opendoor’s risk advisory board.

 

After three successful years with Spinnaker as its leading fronting carrier partner, Hippo, the home insurance group that created a new standard of care and protection for homeowners, closed its acquisition of the company in August 2020. Spinnaker has pioneered value-added fronting insurance by creating products that benefit the producer, the insurer, the reinsurer, and the end-customer. Spinnaker-backed Hippo products are currently available to consumers in more than 34 states.

 

“I’ve been blown away by the combination of innovation and technology that Hippo has deployed alongside Spinnaker and am thrilled to be joining Spinnaker as its CEO,” said Ostergaard. “I look forward to building on the great work of the team that’s established Spinnaker as a premier fronting company to bring its world-class fronting services and technology to the next level for the benefit of our existing partners and as we expand into new categories of business.”

 

Spinnaker recently announced several new partnerships and will continue expanding its support for industry-leading insurance managing general agents (MGAs) across multiple categories. A 2020 Conning study on MGAs showed a 6.3 percent increase in MGA premium volumes from 2018 to 2019 to $45.4 billion.

 

“Torben’s risk management and financial expertise, public company experience at USAA and Fortune 100 executive leadership makes him exceptionally qualified to lead Spinnaker to its next chapter of growth,” said Richard McCathron, President of Hippo Enterprises and Chairman of Spinnaker Insurance Company. “We are incredibly grateful to Dave for bringing the Spinnaker business to this stage and having him remain in a critical leadership role will provide continuity and accelerate business growth, innovation, and expansion into new channels.”

 

About Spinnaker

Spinnaker Insurance Company is a national property and casualty insurer rated A- (Excellent) by A.M. Best Company. With the ability to offer admitted insurance products in 50 states and the District of Columbia, Spinnaker utilizes program administrators and managing general agents to access niche markets, focusing on short-tail business (with an emphasis on homeowners, renters, and small commercial), certain specialty lines, and fronting opportunities. Learn more at www.spinnakerins.com.

 

About Hippo

Hippo Insurance Services offers a different kind of home insurance, built from the ground up to provide a new standard of care and protection for homeowners. Our goal is to make homes safer and better protected so customers spend less time worrying about the burdens of homeownership and more time enjoying their homes and the life within. Harnessing real-time data, smart home technology, and a growing suite of home services, we are creating the first integrated home protection platform. Hippo is headquartered in Palo Alto, California with offices in Austin and Dallas, Texas and insurance products available to more than 70 percent of U.S. homeowners in 34 states. Hippo Insurance Services is a licensed property casualty insurance agent with products underwritten by various insurance companies. For more information, including licensing information, visit http://www.hippo.com.

Contacts

Hippo Insurance Services

Andrea Collins

acollins@hippo.com

Categories
Science Technology

Oncology and hematology specialists, P.A. and Deep Lens partner to integrate clinical trial matching solution VIPER™ into network, expanding offering to patients

COLUMBUS, Ohio & MORRISTOWN, NJ. — (BUSINESS WIRE) — #clinicalresearch—Deep Lens and Oncology and Hematology Specialists, P.A. today announced that they will partner to deploy artificial-intelligence (AI)-based trial matching solution, VIPER™, into the New Jersey-based cancer network. The Deep Lens’ VIPER platform uses proprietary cloud-based technology to facilitate, triage and accelerate the clinical trial recruitment process. Oncology and Hematology Specialists, P.A. is one of the largest cancer care networks in Northern New Jersey, serving patients across Morris county with offices in Morristown and Mountain Lakes. The cancer center utilizes Cardinal Health Specialty Solutions’ distribution and technology services, and was one of the first sites to integrate VIPER into their network since the launch of Cardinal Health™ Navista™ TS. Navista TS is a comprehensive and integrated suite of oncology-focused tech solutions designed to help community oncologists improve outcomes and costs associated with patient treatment as they transition to value-based care. VIPER is a key component of the Navista TS offering.

“Our practice has always focused on adopting and providing the newest, most innovative approaches to cancer care to our patients — from cutting-edge therapeutics to supportive services and wellness events. We are delighted to further expand this offering to our patient community by broadening our clinical trial program through the deployment of VIPER,” said Fazal Bari, M.D. at Oncology and Hematology Specialists, P.A. “VIPER will not only assist our staff in identifying the right trials for our patients, but the larger partnership with Deep Lens will assist in bringing more precision-based trials to our network, thereby giving more opportunities for our patients to access emerging new drugs in development.”

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; however, patient participation in these trials is often as low as three percent. Limited site capacity and resources play a role in the challenge to recruit and enroll, as well as low patient engagement. All of these challenges have been magnified by the current global pandemic. VIPER automates the clinical trial screening process and seamlessly matches patients — at the time of diagnosis — to appropriate trials through the ingestion and analysis of customized genomic data, electronic medical records and pathology data.

“We are delighted to partner with the Oncology and Hematology Specialists’ team to enhance the comprehensive suite of cancer care resources they offer to their patient community,” said Greg Andreola, chief revenue officer at Deep Lens. “We are confident that the inclusion of VIPER will not only help more cancer patients in Northern New Jersey access potentially life-changing new therapies, but it will position the cancer center prominently as a leading clinical research institution. We look forward to helping Oncology and Hematology Specialists optimize the stellar care they are already providing to the patient community in New Jersey.”

Deep Lens’ VIPER will be integrating directly to the Oncology and Hematology Specialists, P.A.’s EMR (Flatiron Health’s OncoEMR), molecular data feeds (Foundation Medicine, Caris Life Sciences and Guardant Health), pathology and imaging feeds to automatically identify qualified patients for clinical trials. Like Oncology and Hematology Specialists, P.A., any practice that utilizes OncoEMR can easily integrate VIPER and all other Deep Lens screening services free of charge.

About Oncology Hematology Specialists, P.A.

Oncology and Hematology Specialists P.A. was founded in 1976 and is one of the leading cancer care facilities in New Jersey. The practice provides care for more than 100 patients per day in two convenient, community-based locations, Morristown and Mountain Lakes. The talented healthcare provider team at Oncology and Hematology Specialists, P.A. manages diagnostic, treatment, nutritional, and prescription-based services for most patients. For more information, please visit www.ohsnj.com.

About Deep Lens

Deep Lens is a software company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials. VIPER, Deep Lens’ integrated cloud platform, provides care teams with visibility and workflows that combine lab, EMR, and genomic data to match cancer patients to clinical trials and precision therapies at the time of diagnosis, accelerating recruitment and compressing study timelines to bring game-changing therapies to market sooner. Growing with sponsors, providers, and strategic partners, Deep Lens challenges the status quo so that patients can get the best therapies. For more information, visit www.deeplens.ai.

Contacts

Deep Lens media contact: Adrienne Kemp, media@deeplens.ai, +1 (949) 922-0801

Oncology Hematology Specialists, P.A. contact: contact@ohsnj.com