Families of some who perished have written pointedly about the virus in remembrances. They tell of agonizing final days. They plead for wearing of masks.
Also, the U.S. starts the vaccine rollout as shots are given in New York. High-risk health care workers are being given priority as the U.S. surpassed more than 300,000 virus-related deaths. Australia and New Zealand intend to establish a travel bubble.
— NYT: Top Stories
The Capitol is seen in Washington, Monday, Nov. 16, 2020, as the House and Senate return to work. (AP Photo/J. Scott Applewhite)
WASHINGTON (AP) — A bipartisan group of lawmakers was unveiling a detailed COVID-19 aid proposal Monday as Congress labored toward a final agreement on a new round of virus relief.
Progress was being reported on other fronts, too, as lawmakers cobbled together a year-end catchall funding package that will be the basis for the last significant legislation of the Trump presidency.
The dozen or so lawmakers sealed agreement on their COVID relief plan over the weekend and decided to offer two bills. One is a $748 billion aid package containing money for struggling businesses, the unemployed, schools, and for vaccine distribution. The other bill proposes a $160 billion aid package for state and local governments and provisions shielding businesses from COVID-related lawsuits, a dynamic favored by Senate Republicans.
The path forward for their proposals — and for COVID-19 aid more generally — remains unclear. Parallel negotiations over virus relief and government funding are proceeding on the leadership level involving House Speaker Nancy Pelosi, D-Calif., and Treasury Secretary Steven Mnuchin. Senate Majority Leader Mitch McConnell, R-Ky., remains central to any agreement. Outstanding issues include a potential second round of direct payments to individuals, a plan for $300 bonus unemployment benefits, state and local aid, and the GOP-sought liability shield against lawsuits.
There’s a hoped-for deadline of midnight Friday to deliver the completed package to President Donald Trump, which is when a partial government shutdown would arrive with the expiration of last week’s temporary funding bill. But there’s no guarantee that the massive year-end measure will be completed in time. If the talks drag, further temporary bills could be needed.
Meanwhile, negotiations on a $1.4 trillion catchall spending bill are “essentially finished,” said a congressional aide participating in the talks. While details are closely held, “the status quo is prevailing.” That means Trump would get another $1.4 billion or so for a final installment to continue construction of his long-sought U.S.-Mexico border wall.
Republicans have succeeded in killing a $12 billion plan to break last year’s budget mini-agreement by using accounting maneuvers to pad veterans health care funding to accommodate big cost increases from expanding access to health care services from private providers. Instead, a different set of moves is being employed to provide for equivalent spending increases for other domestic programs.
At issue are two long-delayed pillars of Capitol Hill’s agenda under divided government — COVID-19 relief and the annual appropriations process by which Congress passes day-to-day agency funding bills. Election-year politics and the maddening dysfunction of the Senate have stalled legislation on both topics for months.
The post-election lame-duck session is the last chance to wrap up the unfinished work this year, a goal of all involved, though they have been slow until now to forge the often-tricky compromises required to pull the measure together.
Pelosi and Mnuchin spoke Sunday afternoon and are likely to be the crucial pair to watch going down the stretch. She has by no means thrown in the towel on her drive to obtain state and local aid, which was part of the almost $2 trillion CARES Act in March.
President-elect Joe Biden wants as much COVID relief as possible but has no direct influence on the negotiations. While he’ll empower Democrats after taking office next year, GOP leaders like McConnell are playing hardball and have forced Pelosi to scale back her demands. And while McConnell supported a $300 per week bonus unemployment benefit this summer, he’s pulled back after the November election.
No. 2 House Democrat Steny Hoyer of Maryland displayed flexibility in an appearance on CNN on Sunday that Republicans interpreted as a harbinger of further Democratic retreat.
“The legislative process is a give and take and the items that I just mentioned are absolutely critical to get done, and although I think state and local assistance is critically important, the others are critically important too,” Hoyer said.
Also in the mix is a deal to curb “surprise medical bills,” the astonishingly high fees charged to patients with health insurance when they are treated by a doctor or hospital outside of their insurer’s provider network. It’s a particular problem for people getting emergency services and for patients undergoing complex surgeries where another specialist might have to be called in.
Although there’s agreement among most lawmakers and the White House that patients should not face thousands of dollars in unexpected bills, legislation has been slow to gel. It’s been blocked by a lobbying war between consumer groups and insurers on one side, and on the other, doctors and investors in medical practices. The potential compromise would ban surprise bills for emergency room visits and scheduled procedures, but McConnell has yet to endorse the agreement.
___
Associated Press writer Ricardo Alonso-Zaldivar contributed.
— Associated Press
People wait in line to vote in Evans, Ga., Monday, Dec. 14, 2020. Early in-person voting began Monday in Georgia for the state’s twin U.S. Senate runoffs. (Michael Holahan/The Augusta Chronicle via AP)
ATLANTA (AP) — What could be the main event in Georgia’s two U.S. Senate runoffs — early in-person voting — got underway Monday, with lines trending shorter than during the first days of early voting for the general election.
More than half of the record 5 million votes in the Nov. 3 general election were cast during its three-week early voting period. Early in-person voting could be even more important in the Jan. 5 runoffs because of the short time frame for voters to request and send back ballots by mail, as the two races decide which party will control the U.S. Senate.
No one expects turnout to be as high as Democrats Raphael Warnock and Jon Ossoff try to oust Republican U.S. Sens. Kelly Loeffler and David Perdue, respectively. But Bernard Fraga, an Emory University professor who studies voting, said overall turnout could reach 4 million.
President Donald Trump has relentlessly pushed baseless claims of widespread fraud in the general election. In an overnight tweet just hours before early voting started, he continued his ongoing attack on Georgia Gov. Brian Kemp, pushing him to take action or risk harming Perdue and Loeffler’s chances.
“What a fool Governor @BrianKempGA of Georgia is,” the president tweeted. “Could have been so easy, but now we have to do it the hard way. Demand this clown call a Special Session and open up signature verification, NOW. Otherwise, could be a bad day for two GREAT Senators on January 5th.”
In contrast to the first day of early voting in October, when more than 125,000 people cast ballots and some people lined up for hours, few long lines were reported Monday.
One question is how many mail-in ballots will be cast in the election. By Friday, 1.2 million mail-in ballots had been requested and 200,000 returned. In the general election, Democrat Joe Biden won 65% of the 1.3 million absentee ballots that were returned in Georgia, a record fueled by the coronavirus pandemic.
Fraga said it’s possible that mail-in ballots, if anything, will be even more favorable for Democrats in the runoff because of attacks on the integrity of mail-in voting by Trump and many Georgia Republicans.
That means early in-person voting, which Trump narrowly won in November, could be even more important for Republicans. Both parties may also drive voters toward the early polls with Christmas and New Year’s holidays looming before Jan. 5.
Republican attacks on mail-in voting also worry some Democrats. Meghan Shannon, 36, voted in person for Ossoff and Warnock on Monday at State Farm Arena in downtown Atlanta partly driven by fears that absentee ballots will be overly scrutinized.
“I think the absentee ballots are going to be questioned when they count the votes,” the architect said. “I wanted to be here in person so my vote is counted and it’s uncontested.”
Melissa McJunkin, 40, voted in Rome, a solidly Republican area in northwest Georgia, and cast her ballot for Perdue and Loeffler, saying they “will help make decisions based on what I think is the right choice.” She’d heard allegations of voter fraud in the general election and was a bit worried about the integrity of the vote in the runoff.
“I’ve never had a problem before now trusting it, but now I feel like there may be something going on that I don’t trust,” she said.
Towanda Jones voted in downtown Atlanta for Ossoff and Warnock and dismissed the fraud allegations, which have been repeatedly denied by election officials.
“The system is working as it should, and I think our current president is just a sore loser,” she said.
The 54-year-old Black hairstylist said police reform was her main priority.
“I have two grown sons,” Jones said. “The amount of Black lives that have been lost due to police brutality upset me.”
Deborah Harp Gibbs of Lilburn said she voted for Perdue and Loeffler “to keep America great.”
Gibbs said it’s important for people to acknowledge the United States as a Christian nation. “I want prayer in school and God Bless America and apple pie,” Gibbs said, adding that she thinks the Republicans could keep things on “the right track.”
Tony Christy, 62, said he was concerned about the balance of power in Washington as he voted in Kennesaw, a conservative-leaning city just northwest of Atlanta, for the two Republicans. If the Democrats win, there will be 50 senators from each party and Vice President-elect Kamala Harris would break a tie.
That would give too much power to the Democrats, he said, because “then not only will they have the presidency, but they’ll have the House and the Senate, which is not a good balance to have.”
But Araya Araya of Lilburn said he voted for Warnock in part to give Biden a chance to get things done.
“I didn’t want the Senate to be majority Republican where everything President-elect Biden is preparing to do is going to get blocked,” Araya said.
Each of Georgia’s 159 counties must offer at least one early voting location during business hours, with many in metro Atlanta offering multiple locations, extended hours and weekend voting. Early voting will continue through Dec. 31 in some places.
Preparation for early voting saw squabbles over cuts to the number of early polling places. The Center for New Data, a nonprofit group, counted 42 early polling sites statewide scheduled to close for the runoff. In some cases, polling places were relocated.
___
Associated Press writers Haleluya Hadero and Kate Brumback in Atlanta; Jeff Martin in Kennesaw, Georgia; and Sophia Tulp in Rome, Georgia; contributed to this report.
— Associated Press
Georgia’s secretary of state infuriated Donald Trump when he stood by Georgia’s presidential election results. Now he has the critical task of overseeing two U.S. Senate runoffs that will determine the fate of the nation.
— NYT: Top Stories
Its excellence in the computer chip market puts it at the center of the battle for global technological supremacy.
— NYT: Top Stories
A nurse in Queens received the coronavirus vaccine during a news conference with Gov. Andrew Cuomo.
— NYT: Top Stories
The tech giant’s popular services like Gmail, Hangouts, Meet and YouTube went offline, halting work across the globe.
— NYT: Top Stories
TOKYO & MUNICH & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced the initiation of TROPION-Lung01, a global pivotal phase 3 head-to-head study of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), versus docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy.
Patients with advanced or metastatic NSCLC without actionable genomic alterations (such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET exon 14 skipping) have demonstrated an unmet need after currently approved front-line and second-line therapies are exhausted. Current treatment guidelines recommend varying combinations of platinum-based chemotherapy and/or immune checkpoint inhibitors in the front-line and second-line settings based on lung cancer subtype, immune biomarker status and other factors.1 For patients whose cancer progresses after initial treatment containing a platinum-based chemotherapy and a checkpoint inhibitor, therapeutic options are limited.1
TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in the majority of adenocarcinoma and squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.
“We recognize the need to continue to improve treatment for patients with NSCLC who are not eligible for currently approved targeted therapies, particularly those who progress following initial treatment with an immunotherapy and platinum-based chemotherapy,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting.”
“TROP2 is highly expressed in NSCLC and other cancers, making it a promising target for therapeutic development,” said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “This trial will provide an opportunity to evaluate a targeted approach with datopotamab deruxtecan, a potent ADC specifically designed to enhance selective tumor cell death, while reducing systemic exposure to chemotherapy.”
TROPION-Lung01 was initiated following the encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated advanced NSCLC observed in the ongoing TROPION-PanTumor01 phase 1 trial, which completed enrollment of patients with lung cancer in October of 2020. Preliminary data from TROPION-PanTumor01 was recently presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program (#ASCO20) and updated data will be presented at an upcoming medical meeting.
About TROPION-Lung01
This global, multicenter, randomized, open-label phase 3 trial will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with advanced or metastatic NSCLC without actionable genomic alterations and with progression on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy received either in combination or sequentially.
Approximately 590 patients will be randomized into two arms in a 1:1 ratio to receive either datopotamab deruxtecan or docetaxel. Randomization will be stratified by histology (squamous versus nonsquamous), most immediate prior therapy and geographic region.
The primary trial endpoints are progression-free survival and overall survival. Secondary endpoints include overall response rate, duration of response, time to response, disease control rate and patient reported outcomes. Safety endpoints include treatment emergent adverse events and other safety parameters. Pharmacokinetic and immunogenicity endpoints will also be evaluated.
The study will enroll patients at sites in North America, South America, Europe and Asia. For more information visit ClinicalTrials.gov.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.5 NSCLC accounts for 80 to 85 percent of all lung cancers.6
For patients with advanced NSCLC that do not carry actionable genomic alterations (i.e., for which no targeted therapies are approved), treatment has traditionally been limited to platinum chemotherapy.7 The introduction of immune checkpoint inhibitors in the past two decades has offered improved survival rates over traditional chemotherapy regimens, creating new options and shifting treatment to a more personalized approach for subsets of patients with NSCLC. Over the past five years, immunotherapies have become part of the treatment paradigm.7
About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers.8 TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in up to 64% of adenocarcinoma and up to 75% of squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.
About Datopotamab Deruxtecan (Dato-DXd; DS-1062)
Datopotamab deruxtecan (Dato-DXd; DS-1062) is one of three lead DXd antibody drug conjugates (ADCs) in the oncology pipeline of Daiichi Sankyo.
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker with a drug-to-antibody ratio (DAR) of four.
TROPION is the broad and comprehensive clinical development program to evaluate the efficacy and safety of datopotamab deruxtecan across multiple TROP2 cancers as both a monotherapy and in combination with other anticancer treatments. In addition to TROPION-Lung01, datopotamab deruxtecan is currently being evaluated in a number of clinical trials, including TROPION-Lung05, a phase 2 study in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with a kinase inhibitor and platinum chemotherapy and TROPION-PanTumor01, a phase 1 study in patients with advanced solid tumors that have progressed on standard treatments or for whom no standard treatment is available, which has completed enrollment of patients into a unresectable advanced NSCLC cohort and is currently enrolling patients into a triple negative breast cancer (TNBC) cohort.
Datopotamab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.
About the Collaboration between Daiichi Sankyo and AstraZeneca
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.
References
1 NCCN Guidelines for NSCLC Version 1.2021.
2 Pak M, et al. World J Surg Oncol. 2012; 10:53.
3 Li Z, et al. Biochem Biophys Res Commun. 2016; 470:197-204.
4 Liu T, et al. PLoS One. 2013; 8:e75864.
5 Bray F, et al. CA: Cancer J. Clin. 2018;68:394-424. Global Cancer Statistics 2018.
6 American Cancer Society. Types of Non-Small Cell Lung Cancer. 2019.
7 Kim SY, et al. Lung Cancer Manag. 2020;9(3): LMT36.
8 Inamura K, et al. Oncotarget. 2017; 8(17):28725-28735.
Contacts
Global/US:
Victoria Amari
Daiichi Sankyo, Inc.
vamari@dsi.com
+1 908 900 3010 (mobile)
EU:
Lydia Worms
Daiichi Sankyo Europe GmbH
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)
Japan:
Masashi Kawase
Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
Like mother like daughter — Beyonce’s daughter, Blue Ivy Carter, is officially a Grammy nominee.
— FOX News
Some House Republicans plan to try to use Congress’ tallying of electoral results on Jan. 6 to tip the election to President Trump. The attempt will put Republicans in a pinch.
— NYT: Top Stories