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Datopotamab Deruxtecan improved progression-free survival versus chemotherapy in patients with previously treated non-small cell lung cancer in TROPION-Lung01 Phase 3 Trial

  • Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors
  • Datopotamab deruxtecan is the first antibody drug conjugate to demonstrate statistically significant improvement in PFS over docetaxel in this setting of high unmet need

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Positive results from the pivotal TROPION-Lung01 phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.

 

These data, the second of two positive late-breaking presentations (LBA12) from the datopotamab deruxtecan clinical development program, were featured during Presidential Symposium 3 at the European Society for Medical Oncology (#ESMO23) 2023 Congress.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

 

Datopotamab deruxtecan reduced the risk of disease progression or death by 25% compared to docetaxel (hazard ratio [HR]=0.75; 95% confidence interval [CI]: 0.62-0.91; p=0.004) as assessed by blinded independent central review (BICR). Median PFS was 4.4 months in patients treated with datopotamab deruxtecan compared to 3.7 months with docetaxel. Results also showed a confirmed objective response rate (ORR) of 26.4% in patients treated with datopotamab deruxtecan compared to an ORR of 12.8% in patients treated with docetaxel. Median duration of response (DoR) was 7.1 months (95% CI: 5.6-10.9) in the datopotamab deruxtecan arm compared to 5.6 months (95% CI: 5.4-8.1) in the docetaxel arm.

 

In patients with non-squamous NSCLC, datopotamab deruxtecan demonstrated a clinically meaningful benefit, reducing the risk of disease progression or death by 37% compared to docetaxel (HR=0.63; 95% CI: 0.51-0.78) as assessed by BICR. Median PFS was 5.6 months in patients treated with datopotamab deruxtecan compared to 3.7 months in those treated with docetaxel. A confirmed ORR of 31.2% was observed in the datopotamab deruxtecan arm, including four complete responses (CRs), versus 12.8% with docetaxel which elicited no CRs. Median DoR was 7.7 months in the datopotamab deruxtecan arm compared with 5.6 months in the docetaxel arm. Datopotamab deruxtecan did not demonstrate a PFS benefit in patients with squamous NSCLC.

 

For the dual primary endpoint of overall survival (OS), interim results numerically favored datopotamab deruxtecan over docetaxel in the overall population (HR=0.90; 95% CI: 0.72-1.13) and in patients with non-squamous tumors (HR=0.77; 95% CI: 0.59-1.01), however, results did not reach statistical significance at the time of this data cut-off. The trial is ongoing and OS will be assessed at a final analysis.

 

“For patients with advanced non-small cell lung cancer, current standard of care second-line docetaxel is associated with limited benefit and substantial toxicity,” said Aaron Lisberg, MD, UCLA Health, Thoracic Medical Oncology and investigator in the trial. “The improvement in progression-free survival observed with datopotamab deruxtecan, particularly in patients with non-squamous tumors, and the improved tolerability of this antibody drug conjugate compared to docetaxel, represent a meaningful advance for patients with lung cancer.”

 

In the TROPION-Lung01 trial, no new safety concerns were identified with datopotamab deruxtecan. The median treatment duration for datopotamab deruxtecan was 4.2 versus 2.8 months for docetaxel. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 25% and 41% of patients in the datopotamab deruxtecan and docetaxel arms, respectively. The most common grade 3 or higher TRAEs were neutropenia (1% vs. 23%), stomatitis (6% vs. 1%), anemia (4% vs. 4%), asthenia (3% vs. 2%), nausea (2% vs. 1%) and fatigue (1% vs. 2%) for datopotamab deruxtecan versus docetaxel, respectively. Grade 3 or higher adjudicated drug-related interstitial lung disease (ILD) events occurred in 3% and 1% of patients in the datopotamab deruxtecan and docetaxel arms, respectively. In the datopotamab deruxtecan arm, there were seven grade 5 ILD events (2%) adjudicated as drug-related by an independent committee. The primary cause of death in four of these cases was attributed to disease progression by the treating investigator. Of the seven adjudicated grade 5 ILD events, four (1.7%) were in patients with non-squamous NSCLC and three (4.6%) were in patients with squamous NSCLC. In the docetaxel arm, one adjudicated drug-related grade 5 ILD event (0.3%) occurred.

 

“These results shown at ESMO from the second of two pivotal trials of datopotamab deruxtecan provide further support for the practice-changing potential of our DXd antibody drug conjugate technology across different targets and types of cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The benefit seen in patients with non-squamous tumors is particularly impressive and, coupled with the data from TROPION-Lung05, provides promising evidence that datopotamab deruxtecan may play an important role in treating patients with non-small cell lung cancer who currently have limited effective options following initial treatment.”

 

“Datopotamab deruxtecan is central to the future we envision where antibody drug conjugates improve upon and ultimately displace entrenched standards of care, like chemotherapy, in multiple cancer types,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “The TROPION-Lung01 results demonstrate for the first time that an antibody drug conjugate can delay disease progression or death for longer than conventional chemotherapy in patients with advanced non-small cell lung cancer. This is particularly noteworthy considering datopotamab deruxtecan was also associated with a lower burden of treatment-related severe adverse events than chemotherapy.”

 

Patient enrollment by tumor histology was consistent across treatment arms and with real world incidence with 78% and 77% of patients in the datopotamab deruxtecan and docetaxel arms, respectively, having non-squamous tumors.1 In the datopotamab deruxtecan arm, patients were previously treated with platinum containing therapy (99%), anti-PD-1/PD-L1 therapy (88%) or targeted therapy (15%). In the docetaxel arm, patients were previously treated with platinum containing therapy (100%), anti-PD-1/PD-L1 therapy (88%) or targeted therapy (16%). In both arms, 17% of patients had tumors expressing actionable genomic alterations, such as epidermal growth factor receptor (EGFR) mutations. At the March 29, 2023 data cut-off, 52 patients remained on treatment with datopotamab deruxtecan and 17 remained on docetaxel.

 

Summary of TROPION-Lung01 Efficacy Results

Overall Trial Population

Datopotamab Deruxtecan (n=299)

Docetaxel (n=305)

Median PFS (months)i (95% CI)

4.4 months (4.2-5.6)

3.7 months (2.9-4.2)

Hazard Ratio (95% CI)

0.75 (0.62-0.91)

p-valueii

p=0.004

Median OS (months) (95% CI)iii

12.4 months (10.8-14.8)

11.0 months (9.8-12.5)

Hazard Ratio (95% CI)

0.90 (0.72-1.13)

ORR (confirmed), % (95% CI)i, iv

26.4% (21.5-31.8)

12.8% (9.3-17.1)

CR rate, %

1.3%

0%

PR rate, %

25.1%

12.8%

Median DoR (months)i (95% CI)

7.1 months (5.6-10.9)

5.6 months (5.4-8.1)

Non-Squamous Histology

Datopotamab Deruxtecan (n=229)

Docetaxel (n=232)

Median PFS (months)i (95% CI)

5.6 months (4.4-7.0)

3.7 months (2.9-4.2)

Hazard Ratio (95% CI)

0.63 (0.51-0.78)

OS Hazard Ratio (95% CI)

0.77 (0.59-1.01)

ORR (confirmed), %i, iv

31.2%

12.8%

Median DoR (months)i

7.7 months

5.6 months

Squamous Histology

Datopotamab Deruxtecan (n=70)

Docetaxel (n=73)

Median PFS (months)i

2.8 months (1.9-4.0)

3.9 months (2.8-4.5)

Hazard Ratio (95% CI)

1.38 (0.94-2.02)

OS Hazard Ratio (95% CI)

1.32 (0.87-2.00)

ORR (%)i, iv

9.2%

12.7%

Median DoR (months)i

5.9 months

8.1 months

CI, confidence interval; CR, complete response; DoR, duration of response; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response

i As assessed by BICR

ii p-value prespecified boundary of 0.008

iii With median follow-up of 11.8 and 11.7 months for the datopotamab deruxtecan and docetaxel arms, respectively; OS data were not mature

iv ORR is (complete response + partial response)

 

TROPION-Lung05 Results

Initial results from the TROPION-Lung05 phase 2 trial showed datopotamab deruxtecan demonstrated encouraging antitumor activity in patients with heavily pretreated locally advanced or metastatic NSCLC with actionable genomic alterations including those with EGFR mutations and anaplastic lymphoma kinase (ALK) rearrangements. The data were presented in a mini-oral session on Saturday, October 21 at the ESMO 2023 Congress (1314MO).

 

In the overall population (n=137), datopotamab deruxtecan demonstrated a confirmed ORR of 35.8% (95% CI: 27.8-44.4), including four CRs and 45 partial responses, and a disease control rate (DCR) of 78.8%. Median PFS was 5.4 months (95% CI: 4.7-7.0). In patients with EGFR mutations (n=78), the largest group of genomic alterations, datopotamab deruxtecan demonstrated an ORR of 43.6% and DCR of 82.1%.

 

In the TROPION-Lung05 trial, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) were stomatitis (10%), anemia (6%), decreased appetite (4%) and fatigue (4%). There were five ILD events (4%) adjudicated as drug-related by an independent committee, including four grade 1 or 2 events and one grade 5 event.

 

About TROPION-Lung01

TROPION-Lung01 is an ongoing global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations previously treated with at least one prior therapy. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and an approved targeted therapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

 

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by BICR and OS. Key secondary endpoints include investigator-assessed PFS, ORR, DoR, time to response, DCR as assessed by both BICR and investigator, and safety.

 

TROPION-Lung01 enrolled approximately 600 patients at sites in Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

 

About TROPION-Lung05

TROPION-Lung05 is an ongoing global, multicenter, single-arm, open-label phase 2 study evaluating the efficacy and safety of datopotamab deruxtecan in patients with locally advanced or metastatic NSCLC with actionable genomic alterations with disease progression on or after at least one tyrosine kinase inhibitor and at least one regimen of platinum-based chemotherapy (with or without other systemic therapies). Patients with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET and who received up to four prior lines of treatment were eligible for the study.

 

The primary trial endpoint is ORR as assessed by BICR. Secondary efficacy endpoints include DoR, best percentage change in the sum of diameters of measurable tumors, DCR, clinical benefit rate, PFS, time to response and OS. Safety endpoints include TEAEs and other safety parameters. TROPION-Lung05 enrolled 137 patients globally. For more information visit ClinicalTrials.gov.

 

About Non-Small Cell Lung Cancer

More than one million people worldwide are diagnosed with advanced NSCLC each year.2,3 Approximately 30% and 70% of NSCLC tumors are of squamous or non-squamous histology, respectively, the latter including adenocarcinoma and large cell carcinoma.1 While immunotherapy and targeted therapies have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive chemotherapy.4,5,6 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC in the absence of other treatment options and despite limited effectiveness and known side effects.4,5,6

 

TROP2, a transmembrane glycoprotein, is broadly expressed in a large majority of NSCLC tumors.7 There are currently no TROP2 directed ADCs approved for the treatment of lung cancer.8,9

 

About Datopotamab Deruxtecan (Dato-DXd)

Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of six ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

A comprehensive development program called TROPION is underway globally with more than 12 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple tumors, including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer. Beyond the TROPION program, datopotamab deruxtecan also is being evaluated in novel combinations in several ongoing trials.

 

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

References

1 National Cancer Institute. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer, 2015. Accessed October 2023.

2 Siegel R, et al. CA Cancer J Clin. 2021;71:7-33.

3 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed October 2023.

4 Chen R, et al. J Hemal Oncol. 2020;13(1):58.

5 Majeed U, et al. J Hematol Oncol. 2021;14(1):108

6 Pircher A, et al. Anticancer Research. 2020;70(5):287-294.

7 Mito R, et al. Pathol Int. 2020;70(5):287-294.

8 Rodríguez-Abreau D et al. Ann Onc. 2021 Jul;32(7): 881-895.

9 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer. Accessed October 2023.

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations:
DaiichiSankyoIR@daiichiankyo.co.jp

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A Twitter user since 2007 reflects on leaving due to Elon Musk swapping stasis at the company for chaos

Leaving Twitter

I was on Twitter since 2007, and built a meaningful part of my career on it, and I won’t be posting at all for the foreseeable future

Benedict Evans:

 

 

—  Twitter always used to look a lot like Craigslist.

 

It stumbled into something that a lot of people found very useful, with very strong network effects, and then it squatted on those network effects for a generation, while the tech industry moved on. Twitter, as a technology company, has been irrelevant to everything that’s going on for a decade. It was the place where we talked about what mattered, but Twitter the company didn’t matter at all – indeed it did nothing for so long that people got bored of complaining about it.

 

Meanwhile, lots of people tried to build a better Craigslist and a better Twitter, but though a better product was pretty easy, the network effects were too strong and none of them really worked. Instead, we unbundled use cases one by one. As Andrew Parker pointed out in 2010, a whole range of people from Airbnb to Zillow to Tinder unbundled separate pieces of Craigslist into billion dollar companies that didn’t look like Craigslist and solved some individual need much better. This is often the real challenge to tech incumbents: once the network effects are locked in, it’s very hard to get people to switch to something that’s roughly the same but 10% better – they switch to something that solves one underlying need in an entirely new way.

 

Hence, Mastodon has been around since 2016 without getting much traction, but slices of conversation, content or industry have been unbundled to Reddit, LinkedIn, Instagram, Signal, Discord or, more recently, Substack, which someone joked was Twitter’s paywall.

 

Meanwhile, Twitter itself drifted aimlessly for a decade, becoming known in Silicon Valley as a place where no-one could get anything done. This is a big part of why Elon Musk was able to buy it – $44bn was a top-of-the-market price, but even Snap was worth $75bn in January 2022, when he started building a stake – how much bigger should Twitter have been? And so, when he made his bid, there was, briefly, a lot of enthusiasm in tech: pent-up frustration with the existing product and a sense of how much better it could be; enthusiasm that there could be innovation and new product ideas (and, from a small but noisy group, frustration with the politics of Twitter’s content policies, of which more in a moment).

 

It didn’t work out like that. The last year swapped stasis for chaos. Stuff breaks at random and you don’t know if it’s a bug or a decision. The advertisers have fled, and no-one knows what will be broken by accident or on purpose tomorrow. The example that’s closest to home for me was that the in-house newsletter product was shut down – and then links to other newsletters were banned. Pick one! It’s hard to see anyone who depends on having a long-term platform investing in anything that Twitter builds, when it might not be there tomorrow.

 

There are various diagnoses for this. Tesla has sometimes been run in chaos as well, but the pain of that is on the employees, not the customers: you can’t wake up in the middle of the night and decide the car should have five wheels and ship that the next day, but you can make those kinds of decisions in software, and Elon Musk does, all the time. Perhaps it’s a fundamental failure to understand how you run a community. Or something else. But whatever the explanation, Twitter now feels like the Brewster’s Millions of tech – ‘Watch One Man Turn $40bn Into $4 In 24 Months!’

 

Meanwhile, beyond the chaos, there has been no sense for the actual users of where we’re going. There was a plan, both ruthless and chaotic, to reset a broken and grotesquely overstaffed company culture and turn it into a place that can execute, but no coherent sense of what it should be executing. What should those newly hard-core engineers be shipping? A ‘super app’? A universal content platform with no external links? Your financial life? Seriously?

 

And then, there are the Nazis.

 

This is a debate with baggage. Part of the criticism of Old Twitter was a perceived tendency to trigger-happy moderation, and there is in fact a pretty mainstream view in the content moderation world that you shouldn’t (or indeed can’t, practically) try to ban and block anything you don’t like (unless it’s actually illegal), but instead you should have a spectrum of what’s objectionable and control things within that by controlling visibility. Keep things out of the recommendations and suggestions, down-rank them in the feed and replies, and don’t let them monetise or advertise. There will be some bad stuff, but the worse it is the fewer people will see it. Meanwhile, pour your effort into stopping scammers and state manipulation, and think about how your product design might encourage or discourage the rest of us from being mean. Reasonable people can disagree about that. But.

 

But it didn’t work out like that. The teams that looked for bots, scammers and state actors were mostly fired, and the scammers, Nazis and propagandists all bought the ‘Blue Ticks’. These little badges used to mean ‘notable person’ (in a chaotic and inconsistent way typical of the old Twitter) and are now supposed only to mean ‘real person’ (but often don’t) – and they give you both amplification in all the algorithms and a share of revenue if you drive a lot of replies. The more you troll, and the more furious replies you generate, the more Twitter promotes you and the more Twitter pays you. We saw this at its logical conclusion in the last week, with deliberate misinformation promoted by what we used to call ‘fake accounts’ that now get promoted by the algorithm because they pay their $8/month. It turns out that social networks are harder than rocket science.

 

And then, there’s Elon.

 

I once called Elon Musk ‘a bullshitter who delivers’ – he says a lot of stuff, and yet, there are the cars and the self-landing rockets. People generally struggle with one or other of these – they will refuse to accept the problem in selling a car that can’t drive itself as ‘full self driving’, or they will say ‘he didn’t found Tesla!’, forgetting that he’s run it for the last 15 years. Most of what you see at Tesla or SpaceX really is his creation – but half of what he says is bullshit.

 

Until recently, though, the bullshit was mostly about cars or tunnels. It wasn’t repeating obvious anti-semitic dog-whistles. It wasn’t telling us that George Soros is plotting to destroy western civilisation. It wasn’t engaging with and promoting white supremacists. It wasn’t, as this week, telling us all to read a very obvious misinformation account, with a record of anti-semitism, as the best source on Israel. Of course, it had bought a Blue Tick.

 

In talking about this, I am reminded very much of talking about the last leader of the UK’s Labour Party, Jeremy Corbyn, who had somehow spent much of a career devoted to anti-racism, well, supporting and praising anti-semites (‘the world’s most unlucky anti-racist’). The Chief Rabbi declared that British Jews were afraid of a Labour election victory, and yet too many people with a tribal loyalty to the party just refused to read, see or hear any of this. They decided to blind themselves.

 

If you see a man claim that he’ll have ‘full self-driving’ working ‘next year’ for half a decade and can’t make fun of that just a little, you are probably blinding yourself too, but it does’t matter much. And maybe you don’t care much about this, or have decided not to see it. But I was on Twitter since 2007, and built a meaningful part of my career on it, and I won’t be posting at all, for the foreseeable future, because I think it does matter.

 

 

— Techmeme

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‘Taylor Swift: And the Clothes She Wears’ is finally here — and it’s already a no. 1 bestseller on Amazon

No surprise: “Taylor Swift: And the Clothes She Wears,” the newest fashion book from style expert Terry Newman, is an immediate bestseller upon its release this week.

 

The 160-page coffee table book tracks the intriguing style evolution of one of the biggest pop-stars of our generation, from her earliest days as a teenage country singer in Nashville to her show-stopping red carpet looks at events such as the Met Gala, Grammys and, of course, her most recent “Eras Tour.”

 

“A born storyteller, her outfits mark the different phases of her whirlwind life every bit as clearly as her songs,” the book’s logline reads. “From cowboy boots to cottage-core, Saint-Laurent to sci-fi, onstage and on the street, her clothes are always carefully chosen to match the moment. These pages reveal those moments in gorgeous photographic detail with reliably astute analysis.”

 

The Swift book is the most recent in a long line of celebrity style anthologies from Newman, who has worked in the fashion industry for more than 20 years as an editor and writer. Earlier bestselling books include “Harry Styles: And the Clothes He Wears,” “Rihanna: And the Clothes She Wears”
and “Beyonce: And the Clothes She Wears,” among others.

 

The release comes at a particularly apt time, following the singer’s record-breaking “Eras Tour,” which mostly concluded in August (aside from 15 additional shows scheduled for next year). Despite taking a break from the stage, she’s remained in the headlines: her “Eras Tour” concert film landed the best box office debut of all time for a concert film, and her recent NFL appearances have broken national television ratings record.

 

Given the current media frenzy surrounding Swift, it’s no surprise that Newman’s new book on the pop star is already a No. 1 bestseller on Amazon.

 

 

— Variety

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Business International & World Regulations & Security Technology

WIPO: In 2022, Chinese entities applied for 29,853 AI patents, up from 29,000 in 2021, almost 80% more than the 16,800 US filings, down from 17,800 in 2021

—  Patent filings from China almost doubles the sum of US in 2022 

— Top players like Baidu, Alibaba race to monetize AI products

 

 

Bloomberg:

 

China is increasing its lead over the US in AI patent filings, underscoring the Asian nation’s determination to shape and influence a technology that could have broad implications for the world’s richest economies.

Chinese institutions applied for 29,853 AI-related patents in 2022, climbing from 29,000 the year prior, according to data that the World Intellectual Property Organization provided to Bloomberg News. That’s almost 80% more than US filings, which shrank 5.5%. Overall, China accounted for more than 40% of global AI applications over the past year, the data from the United Nations-affiliated agency showed. Japan and South Korea rounded out the 2022 leaders, with a combined 16,700 applications.

 

 

R&D Drive

Patent applications for AI-related inventions

World Intellectual Property Organization

Data are subject to revision

 

The numbers illustrate how Beijing has pushed Chinese companies and agencies to gain an edge in areas such as chipmaking, space exploration and military sciences. More recently, President Xi Jinping has ordered the nation to accelerate fundamental research in response to US efforts to curtail its access to advanced technologies. That’s triggered a flood of investment by Chinese companies in AI and quantum computing.

Baidu Inc. is now vying with Alibaba Group Holding Ltd. and Tencent Holdings Ltd.  as well as startups such as Baichuan and Zhipu to develop a local answer to US rival OpenAI’s groundbreaking generative AI chatbot ChatGPT.

 

China is Leading the World in AI Patents Filing

It overtook the US in 2017 and has widened the gap since

Source: WIPO

 

Academics close to decision-makers in Beijing have argued that building an arsenal of patents is one of the most effective ways to counter Washington’s campaign of restrictions. Not all patent filings result in real-world inventions, but Chinese firms such as Huawei Technologies Co.  have established a track record of leading innovation in the past in sectors such as networking, supercomputing and image recognition.

China surpassed the US in the number of AI filings as far back as 2017, when local firms accelerated the use of algorithms in an array of businesses from car-hailing to online shopping.

 

— With assistance by Thomas Pfeiffer and Yuan Gao

— Techmeme

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Business Healthcare Lifestyle Science

KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) reduced risk of death by more than half versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer

KEYTRUDA plus enfortumab vedotin significantly prolonged overall survival (OS) by 53% – an improvement in median OS of more than 15 months – compared to chemotherapy in the total patient population

Late-breaking results from the Phase 3 KEYNOTE-A39/EV-302 trial were selected for the official Press Briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2023

 

 

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, on Sunday announced results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, compared to chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

 

Findings from its first pre-specified analysis showed that KEYTRUDA plus enfortumab vedotin significantly improved overall survival (OS), reducing the risk of death by 53% compared to chemotherapy (median OS, 31.5 months vs. 16.1 months, respectively), an improvement in median OS of more than 15 months; (HR=0.47 [95% CI, 0.38-0.58]; p<0.00001). KEYTRUDA plus enfortumab vedotin also achieved a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 55% (median PFS, 12.5 months vs. 6.3 months, respectively); (HR=0.45 [95% CI, 0.38-0.54]; p<0.00001). Results were consistent across all predefined subgroups, including patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, patients whose tumors expressed both high (Combined Positive Score [CPS] ≥10) or low (CPS <10) levels of PD-L1, and patients with or without liver metastases. These late-breaking data are being presented for the first time today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA6) and are included in the official ESMO Press Briefing.

 

“As an investigator in this trial and a physician who treats patients with advanced urothelial cancer, I can attest to the challenging nature of this diagnosis for patients and their families,” said Dr. Thomas Powles, KEYNOTE-A39 primary investigator, professor of Genitourinary Oncology and director, Barts Cancer Center. “These results, showing a 53% reduction in the risk of death for the combination compared to chemotherapy, are striking and may open a new chapter for the treatment of these patients diagnosed with advanced urothelial carcinoma, who face an urgent need for new therapies.”

 

“Our goal is to extend the lives of patients with cancer, and these unambiguous survival findings from KEYNOTE-A39 showing that KEYTRUDA plus enfortumab vedotin reduced the risk of death by half when compared to chemotherapy are important to patients and the medical community alike,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These results – the first positive Phase 3 results combining a PD-1 inhibitor and an antibody-drug conjugate in this patient population – have the potential to change the treatment paradigm for previously untreated patients with advanced urothelial cancer regardless of whether patients are eligible or ineligible for cisplatin.”

 

The Phase 3 KEYNOTE-A39 trial is intended to serve as the basis for global regulatory submissions and as the confirmatory trial for the current U.S. accelerated approval of KEYTRUDA plus enfortumab vedotin as first-line treatment for patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy. The accelerated approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K.

 

As announced, data spanning more than 15 types of cancer are being presented from Merck’s broad oncology portfolio and investigational pipeline at the ESMO Congress 2023.

 

Study design and additional data from KEYNOTE-A39 (EV-302)

The KEYNOTE-A39 trial (ClinicalTrials.gov, NCT04223856) is an open-label, randomized, controlled Phase 3 trial evaluating KEYTRUDA plus enfortumab vedotin compared to chemotherapy (gemcitabine plus cisplatin or carboplatin) for the treatment of patients with previously untreated la/mUC. The trial enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status. The dual primary endpoints are PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and OS. Secondary endpoints include objective response rate (ORR) per RECIST v1.1 by BICR, time to pain progression and duration of response (DOR) per RECIST v1.1 by BICR. The study enrolled 886 patients, randomized to receive either:

  • KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first) plus enfortumab vedotin (125 mg/m2 by IV on Days 1 and 8 of each three-week cycle for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs); or
  • Gemcitabine (administered as IV infusion on Days 1 and 8 of each three-week cycle) plus platinum-containing chemotherapy (either carboplatin [administered by IV on Day 1 of each three-week cycle] or cisplatin [administered by IV on Day 1 of each three-week cycle]) for a maximum of six cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

 

In KEYNOTE-A39, KEYTRUDA plus enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in the secondary endpoints of ORR and DOR. Confirmed ORR by BICR was 67.7% (95% CI, 63.1%-72.1%) in the KEYTRUDA plus enfortumab vedotin arm and 44.4% (95% CI, 39.7%-49.2%) in the chemotherapy arm (p<0.00001). Median DOR was not reached in the KEYTRUDA plus enfortumab vedotin arm; in the chemotherapy arm, median DOR was seven months.

 

59% of patients in the chemotherapy arm received a PD-1/PD-L1 inhibitor as first subsequent systemic therapy, either as maintenance or second-line therapy.

 

The safety profile for KEYTRUDA plus enfortumab vedotin was consistent with results observed in the Phase 1/2 KEYNOTE-869/EV-103 trial. Treatment-related adverse events of any grade occurring in ≥20% of patients include peripheral sensory neuropathy, pruritus, alopecia, maculo-papular rash, fatigue, diarrhea, decreased appetite, and nausea.

 

About bladder and urothelial cancer

Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis and some other organs. In the U.S., it is estimated that approximately 82,300 people will be diagnosed with bladder cancer in 2023. Globally, it is estimated that approximately 573,000 new cases of bladder cancer are reported annually. Approximately 12% of cases are la/mUC at diagnosis. Many patients with advanced urothelial carcinoma face a poor prognosis and experience disease progression following initial treatment with chemotherapy.

 

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Urothelial Carcinoma

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

 

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

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

  • who are not eligible for any platinum-containing chemotherapy, or
  • who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

See additional selected indications for KEYTRUDA in the U.S. after the Selected Important Safety Information.

 

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. 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 KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, 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 adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus 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. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

 

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

 

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

 

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. 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 indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

 

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

 

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

 

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

 

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

 

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Chrissy Trank

(640) 650-0694

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

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Mobile Academy to launch AACCNJ Entrepreneur Academy

TRENTON, NJ – The African American Chamber of Commerce New Jersey’s (AACCNJ) Mobile Academy is pleased to announce the formation of the AACCNJ Entrepreneur Academy.

 

This eight-part program is tailored to empower new entrepreneurs and those considering business ownership by equipping them with the knowledge and skills needed to succeed in their ventures. All classes will be free of charge, facilitated by seasoned entrepreneurs and consultants, and held in-person at Mill One located at 1 N. Johnston Ave., Hamilton, NJ.

 

“We are excited to offer this opportunity to aspiring entrepreneurs in New Jersey,” said John E. Harmon Sr., IOM, Founder, President and CEO of AACCNJ.

 

“The AACCNJ Entrepreneur Academy empowers individuals from all backgrounds to take the next step toward realizing their dreams of self-sufficiency and generational wealth creation. By providing this program at no cost, we aim to remove barriers and ensure that all interested individuals have the chance to participate.”

 

The AACCNJ Entrepreneur Academy will cover a wide range of topics crucial to entrepreneurial success, including:

 

  1. ABCs of Starting a Small Business
  2. Writing a Business Plan/QuickBooks
  3. Goal Setting
  4. Marketing Your Business
  5. 5 Cs of Credit/Access to Capital
  6. Accounting Do’s and Don’ts and Taxes
  7. Networking 101
  8. Excellent Customer Service
  9. How to Obtain MBE or WMBE Certifications

 

The academy is a testament to AACCNJ’s ongoing commitment to fostering economic growth and equity in disadvantaged communities. This initiative aligns with AACCNJ’s mission to provide resources, opportunities, and information to individuals looking to make a meaningful impact in the business world.

About the African American Chamber of Commerce of New Jersey

The African American Chamber of Commerce of New Jersey (AACCNJ) performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centered on education and public policy. The AACCNJ serves as a proactive advocacy group and holds a 501(c)(3) tax exemption, as does the National Black Chamber of Commerce, with which the AACCNJ is affiliated.

 

Click here to be considered for the academy’s inaugural cohort. For any inquiries or assistance, please send an email to mobileacademy@aaccnj.com.

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The AZEK® Company named in 2024 best companies to work for: List by U.S. News & World Report

CHICAGO — (BUSINESS WIRE) — The AZEK Company Inc. (NYSE: AZEK) (“AZEK” or the “Company”), the industry-leading manufacturer of beautiful, low-maintenance and environmentally sustainable outdoor living products, including TimberTech® decking and railing, Versatex® and AZEK® Trim, and StruXure™ pergolas, was awarded a place on the U.S. News & World Report inaugural list of best companies to work for in the construction and materials category.

 

“It is an honor to be recognized for our continued focus on prioritizing employee growth and well-being as well as creating a workplace where our employees feel fulfilled, engaged, empowered, and valued,” said Sandra Lamartine, Chief Human Resources Officer at The AZEK Company.

 

“Each one of our team members makes our workplace special and I’m excited for what this means for them and for our future.”

 

The global authority in rankings and consumer advice, U.S. News & World Report ranked AZEK among the 349 best publicly traded companies to work for across 20 industries, considering quality of pay, work-life balance, belongingness and esteem, and opportunities for professional development and advancement by industry.

 

The evaluation of how a company performs on each metric was based on subjective analysis and editorially curated selections of publicly available employee sentiment and other data that demonstrates how a company supports the everyday experience of its workers. The editors compared each company to its peers in one of 20 broad industry groups, awarding “Best” status only to the top 20 percent.

 

The full U.S. News & World Report 2024 list of Best Companies to Work For is currently available here.

 

About The AZEK® Company

The AZEK Company Inc. (NYSE: AZEK) is the industry-leading designer and manufacturer of beautiful, low maintenance and environmentally sustainable outdoor living products, including TimberTech® decking and railing, Versatex® and AZEK Trim® and StruXure™ pergolas. Consistently recognized as a market leader in innovation, quality and aesthetics, products across AZEK’s portfolio are made from up to approximately 90% recycled material and primarily replace wood on the outside of homes, providing a long-lasting, eco-friendly and stylish solution to consumers. Leveraging the talents of its approximately 2,000 employees and the strength of relationships across its value chain, The AZEK Company is committed to accelerating the use of recycled material in the manufacturing of its innovative products, keeping millions of pounds of waste out of landfills each year, and revolutionizing the industry to create a more sustainable future. The AZEK Company has recently been named one of America’s Climate Leaders by USA Today, a Top Workplace by the Chicago Tribune and a winner of the 2023 Real Leaders® Impact Awards. Headquartered in Chicago, Illinois, the company operates manufacturing and recycling facilities in Ohio, Pennsylvania, Idaho, Georgia, Nevada, New Jersey, Michigan and Minnesota. For additional information, please visit azekco.com.

Contacts

AZEK Media Contact:
Amanda Cimaglia

312-809-1093

media@azekco.com

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Digibee appoints Nithin Bose as chief customer officer

Following a $60 million series B round and CRO hire, Digibee further expands its C-suite with an industry veteran who will be a critical touch point for Digibee customers, investors and teams


WESTON, Fla. — (BUSINESS WIRE) — Digibee, an integration-platform-as-a-service (iPaaS) company that helps organizations build flexible, highly scalable integration architecture with low code, on Thursday announced the appointment of Nithin Bose as chief customer officer.

 

With over 20 years of experience in building and deploying enterprise data products, Bose is a seasoned leader in customer success, sales engineering, professional services and support. He has a proven track record of scaling product and customer success organizations, driving revenue growth and enhancing product-market fit. He will report to CEO Rodrigo Bernardinelli and serve as a member of the leadership team, unifying customer success, customer support, professional services and solution architecture functions under one umbrella to drive optimal outcomes for the company’s global customers.

 

“Following a successful series B funding round, it is critical that Digibee have the right leaders in place to scale the company through the next stage of growth and beyond. Nithin’s passion, dedication, and impressive work in customer success will help advance our leadership position in digital transformation and customer service, experience and success,” said Bernardinelli.

 

“I joined Digibee because I was drawn to the company’s strong platform, passionate customer-focused team and disruptive approach to integration in a fast-growing market. There is a massive opportunity to bring Digibee’s cloud-native, low-code and high-productivity approach to more enterprise integration customers and complex use cases. The timing is right for Digibee’s success as a leading integration platform to be advanced globally,” said Bose.

 

Bose previously served as vice president of product and customer success at Very Good Security, a data security platform which secures the storage and exchange of the world’s payment data while maximizing its utility. There, he was the executive responsible for the post-sale customer journey including adoption, expansion and renewals for hundreds of customers. He improved net retention to more than 130% while growing the overall business by over 500%. He established customer engagement programs driving the Net Promoter Score (NPS) to 60 and built a global team from the ground up to drive sales engineering, customer success, professional services and customer support. He also launched multiple new product offerings to better serve customers and rebuilt product management, product marketing and design functions to drive innovation. He also held customer success leadership roles at Splunk, Deloitte, ServiceSource and other B2B IT product organizations.

 

Bose holds a Bachelor of Engineering degree in computer science from the R.V. College of Engineering, Bangalore, India, and a Master of Science degree in computer engineering from the New Jersey Institute of Technology. He is based in the San Francisco Bay Area.

 

About Digibee

The Digibee integration platform allows enterprises to compete and excel in today’s rapidly changing digital environment. The technology is cloud native, low code, fully recyclable and discoverable — connecting applications, processes and people for faster time to market without a major investment. Digibee is the preferred iPaaS solution for 250-plus corporate customers including Assai, B3, Barkley, Bauducco, GoPro, Oobe, Payless, and others. For more information visit Digibee.com.

Contacts

Sara Black

Bospar

prfordigibee@bospar.com

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Organon to report third quarter results and host conference call on Nov. 2, 2023

JERSEY CITY, N.J. — (BUSINESS WIRE) — Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its third quarter 2023 financial results on Nov. 2, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

 

Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website.

Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link: https://conferencingportals.com/event/VfCOQYEG.

 

Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call.

 

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, Twitter and Facebook.

Contacts

Organon Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Organon Investor:

Jennifer Halchak

(201) 275-2711

Alex Arzeno

(203) 550-3972

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Altus Power and Brightcore Energy announce completion of multiple solar projects across New Jersey

Clean electric power to benefit local residents through New Jersey’s Community Solar program

 

STAMFORD, Conn. — (BUSINESS WIRE) — Altus Power, Inc., (NYSE: AMPS), the leading commercial-scale provider of clean electric power, and Brightcore Energy, a leader in developing and implementing renewable energy solutions for the commercial and institutional market, on Thursday announced the completion of 19 solar arrays across New Jersey utilizing rooftops from Brennan Investment Group’s portfolio of logistics buildings. In total, the assets will represent 7.4 megawatts (MWs) of solar arrays which will be owned and operated by Altus Power and will offer the benefits of clean, electric power to the local community.

 

“New Jersey has one of the fastest growing community solar programs in the country and Altus Power and Brightcore Energy have been working together to make this program a reality,” said Gregg Felton, co-CEO and co-founder, Altus Power. “Brennan has proven to be an important partner for Altus in developing and constructing solar projects that will benefit the entire community.”

 

“We are pleased to have the opportunity to work with Altus Power and Brennan to develop this project to bring green, sustainable energy to the surrounding communities. This project was rather unique in that it encompassed so many locations within one project. There was quite a bit of coordination to align all the logistics,” said Mike Richter, President of Brightcore Energy.

 

The 7.4 MWs add to Altus Power’s total of 120 MWs across New Jersey as of June 30th of this year and is part of the expected 40 MWs to be completed in the state by the end of 2023. The Brennan assets are expected to produce clean electricity avoiding the equivalent of 5,200 metric tons of carbon dioxide annually.

 

Altus Power serves more than 20,000 Community Solar subscribers nationwide. Community Solar provides homeowners and renters of diverse income brackets access to the benefits of clean energy and power bill savings without the requirement of roof space or home-installation of solar panels. Customers interested in the benefits of clean energy can learn more by visiting www.altuspower.com.

 

About Altus Power

Altus Power, based in Stamford, Connecticut, is the leading commercial-scale provider of clean electric power serving commercial, industrial, public sector and Community Solar customers with end-to-end solutions. Altus Power originates, develops, owns and operates locally-sited solar generation, energy storage and charging infrastructure across the nation. Visit www.altuspower.com to learn more.

 

About Brightcore Energy

Brightcore Energy, based in Armonk NY, is a leading provider of end-to-end clean energy solutions to the commercial and institutional market. Solutions include high-efficiency heating and cooling systems (geothermal) for both new construction and existing building retrofits, commercial-grade solar, LED lighting and controls, energy storage, electric vehicle (EV) charging stations, smart building solutions, and other emerging technologies. Brightcore’s turnkey, end-to-end solutions encompass; preliminary modeling & feasibility, design & engineering, financing & incentive management, construction & implementation, and system performance monitoring. Visit www.BrightcoreEnergy.com to learn more.

Contacts

For More Information:
Chris Shelton

Head of Investor Relations

mediarelations@altuspower.com