Arvinas, Pfizer announce VERITAC-2 trial did not reach statistical significance

Arvinas (ARVN) and Pfizer (PFE) announced detailed results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, MBC, whose disease progressed following prior treatment with cyclin-dependent kinase, CDK, 4/6 inhibitors and endocrine therapy. These data, which were highlighted in the American Society of Clinical Oncology press briefing and selected for Best of ASCO, will be presented today in a late-breaking oral presentation and have been simultaneously published in the New England Journal of Medicine. In the trial, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, PFS, among patients with an estrogen receptor 1, ESR1, mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant. The median PFS, as assessed by blinded independent central review, BICR, was 5.0 months with vepdegestrant versus 2.1 months with fulvestrant. Investigator-assessed PFS was consistent with the BICR-assessed PFS. In patients with ESR1 mutations, vepdegestrant demonstrated a consistent PFS benefit over fulvestrant across all pre-specified subgroups. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat population, with a median PFS of 3.7 months for vepdegestrant versus 3.6 for fulvestrant.

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Boston Globe

4 hours ago

• Boston Globe

What visuals show of damage to Iran's nuclear sites after US strike

In an image provided by Maxar Technologies, the ridge at the Fordow underground complex is seen after the United States struck the nuclear facility near Qom, Iran, on Sunday, June 22, 2025. SATELLITE IMAGE ©2025 MAXAR TECHNOLOGIES/NYT Advertisement Blast analysts cautioned against drawing conclusions too quickly, as underground impacts depend on a variety of factors, including depth of detonation and surrounding geology. Between 1:45 and 2:30 a.m. local time, satellites used for spotting fires and severe weather around the world appear to have detected significant heat-related events close to the Fordow site. The heat signatures were captured in a location that experts said was used for air defense at the site. Gen. Dan Caine, the chairman of the Joint Chiefs of Staff, said that as the B-2 stealth bombers carrying bunker-busting Massive Ordnance Penetrators approached Fordow and Natanz, U.S. forces deployed 'suppression weapons' against any potential Iranian surface-to-air threats. Ultimately, Iran's air-defense systems did not appear to fire at the U.S. aircraft on their way in and out of Iranian airspace, Pentagon officials said. Advertisement About 2:10 a.m. local time, Caine said, the lead B-2 bomber dropped the first two GBU-57 MOPs on the Fordow facility. The 30,000-pound precision-guided bombs are designed to destroy subterranean targets. In total, seven B-2s dropped 14 bombs at Fordow and Natanz, according to officials. Satellite images taken Sunday morning show two clusters of three entry points along the ridge above the Fordow facility, according to experts who reviewed imagery of the aftermath. In an image provided by Maxar Technologies, a crater is visible over the underground Natanz Enrichment Facility after it was hit by United States airstrikes, near Natanz, Iran, on Sunday, June 22, 2025. SATELLITE IMAGE ©2025 MAXAR TEC/NYT The analysts said the strikes appear to have targeted the 250-meter-long cascade hall - the main part of the facility where the centrifuges are located - which was built into the mountain and later covered. Clustering several munitions around a single point of impact is a common targeting method for destroying bunkers and well-hardened structures, said Wes Bryant, the former chief of civilian harm assessments at the Pentagon's Civilian Protection Center of Excellence. Satellite images from the days before the U.S. strike showed 'unusual truck and vehicular activity' at Fordow, according to a senior analyst at the satellite firm Maxar Technologies. On Thursday, there were 16 cargo trucks along the access road leading to the underground military complex. Images taken the next day show that most of the trucks had moved a little more than a half-mile northwest, farther from the facility, according to the analysis. Other trucks and bulldozers were positioned near the site's entrance, including one truck directly next to it. Spencer Faragasso, senior research fellow at the Institute for Science and International Security, who reviewed an image taken Saturday before the strikes, said among other reasons, the Iranians may have backfilled the tunnels as a precautionary measure to prevent the spread of hazardous material. Advertisement This satellite image provided by Maxar Technologies shows a close view of the Isfahan nuclear technology in Iran after U.S. strikes, Monday, June 22, 2025. Uncredited/Associated Press 'They probably shut things down and removed what they could, then sealed it up,' Jeffrey Lewis, director of the East Asia Nonproliferation Project at the Middlebury Institute's James Martin Center for Nonproliferation Studies, said in a message, leaving Washington and Jerusalem to play 'whack-a-mole with Iran.' Now, the tunnel entrances near where trucks were seen appear to be filled with dirt, either from the shock wave of the bombing or from previous Iranian activity. A coating of gray-blue ash made of debris from the facility lays across the sand. Jonathan Baran, Alex Horton and Souad Mekhennet contributed to this report.

Yahoo

2 days ago

• Yahoo

Pfizer vs BMY: Which Oncology Drugmaker Is a Better Choice for Now?

Pharma/biotech giants Pfizer PFE and Bristol Myers BMY boast of a dominant position in the lucrative oncology space. Oncology or cancer is one of the most sought-after areas in the pharma/biotech space. As the world at large continues to grapple with a significant increase in the number of cancer patients, the market for cancer medicines is expected to grow. Pfizer is one of the largest and most successful drugmakers in the field of oncology. Oncology sales comprise around 25% of its total revenues. Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space. Both drugmakers have strong footholds in their respective target markets, delivering consistent returns to shareholders. In such a scenario, choosing one stock over another can be challenging. Let us delve into their fundamentals, potential growth prospects, challenges and valuation levels to make a prudent choice. Pfizer has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immunotherapies that treat a wide range of cancers, including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and lung cancer. Approved drugs in the portfolio include Ibrance, Xtandi, Inlyta, Lorbrena, Bosulif, Braftovi, Mektovi, Orgovyx, Elrexfio and Talzenna. Among these, the breast cancer drug Ibrance is one of the top revenue generators. The acquisition of Seagen in December 2023 strengthened PFE's oncology portfolio by adding four ADCs — Adcetris, Padcev, Tukysa and Tivdak. This initiative boosted oncology sales in 2024 and the first quarter of 2025. Seagen also has some next-generation ADC candidates in its pipeline and their successful development should further strengthen its portfolio. PFE is working on the label expansion of many of its cancer drugs that should boost sales. Pfizer also has oncology biosimilars in its portfolio and markets six of them for cancer. Oncology biosimilars primarily include Retacrit, Ruxience, Zirabev, Trazimera and Nivestym. Pfizer is also advancing a robust pipeline of oncology candidates, with several entering late-stage development. By 2030, it expects to have eight or more blockbuster oncology medicines in its portfolio. Apart from oncology, Pfizer's portfolio has a variety of drugs and vaccines for diseases like COVID-19, inflammation & immunology diseases, rare diseases and migraine, among others. BMY is focused on extending and strengthening its leadership in immuno-oncology (IO), as well as diversifying beyond IO. Leading IO drug Opdivo, approved for several cancer indications, drives its oncology franchise along with Yervoy and Opdualag. The FDA recently granted approval to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. Per BMY, this new subcutaneous formulation of Opdivo should help extend the reach and impact of its immuno-oncology franchise to patients into the next decade. Reblozyl, approved for first-line MDS-associated anemia, continues to drive market share within the larger first-line ring sideroblasts negative population. The CAR-T cell therapy Breyanzi is approved to treat the broadest array of B-cell malignancies. BMY has also been active on the acquisition front to expand its oncology portfolio/pipeline. In 2024, BMY acquired Mirati, a commercial-stage targeted oncology company, obtaining the rights to commercialize lung cancer medicine Krazati and to further develop several clinical assets, including PRMT5 Inhibitor. Krazati, a KRAS inhibitor, is approved for second-line non-small cell lung cancer (NSCLC) and is in clinical development with a PD-1 inhibitor for first-line NSCLC. It is also FDA approved for advanced or metastatic KRAS-mutated colorectal cancer with cetuximab. In addition, PRMT5 Inhibitor is a potential first-in-class MTA-cooperative PRMT5 inhibitor, which is advancing to the next stage of development. The acquisition of RayzeBio, a leader in the field of radiopharmaceuticals for solid tumor oncology, provided BMY with RYZ101, a late-stage asset, an investigational new drug engine and in-house manufacturing capabilities. In 2022, BMY acquired Turning Point and added lead asset, repotrectinib, and other clinical and pre-clinical stage assets to its pipeline. Repotrectinib was approved by the FDA in November 2023 and is marketed under the brand name Augtyro. Augtyro, a kinase inhibitor, is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It is also intended for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Bristol Myers is also focused on developing drugs with presence in hematology, immunology, cardiovascular, neuroscience and other therapeutic areas. The Zacks Consensus Estimate for PFE's 2025 sales implies a year-over-year decrease of 0.6%, and that for earnings per share (EPS) suggests a year-over-year decline of 1.61%. EPS estimates for 2025 and 2026 have moved north in the past 60 days. Image Source: Zacks Investment Research The Zacks Consensus Estimate for BMY's 2025 sales implies a year-over-year decrease of 4.13% while that for EPS suggests an increase of 487.83%. The extraordinary EPS growth rate is attributed to an extremely low EPS figure in 2024 due to acquisition expenses. EPS estimates for both 2025 and 2026 have moved south in the past 60 days. Image Source: Zacks Investment Research From a price-performance perspective, PFE has performed better than BMY so far this year. Shares of PFE have declined 6.8%, while those of BMY have lost 15.4%. The large-cap pharma industry has declined 0.3% in the said period. Image Source: Zacks Investment Research From a valuation standpoint, we use the P/E ratio of the large-cap pharma industry to compare these companies. Going by the same, PFE is slightly more expensive than BMY. PFE's shares currently trade at 7.77X forward earnings, higher than 7.22 for BMY. Image Source: Zacks Investment Research PFE and BMY's attractive dividend yield is a strong positive for investors. However, PFE's dividend yield of 7.2% is higher than BMY's 5.29%. Large pharma/biotech companies are generally considered safe havens for investors interested in this sector. However, with both PFE and BMY stocks currently carrying a Zacks Rank #3 (Hold), choosing one over the other is a complex task. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. PFE has a strong and diverse portfolio but faces challenges like declining sales of its COVID-19 products and U.S. Medicare Part D headwinds in 2025. Several of its key products face patent expirations. Nonetheless, drugs like Vyndaqel, Padcev and Eliquis, and newly acquired products should continue to drive top-line growth. BMY's efforts to revive the top line in the face of generic challenges for key drugs are commendable. However, we believe there is still time before the efforts reap harvest for the company. The outlook for 2025 indicates challenges as of now. Hence, PFE is a better pick at present (despite its slightly pricey valuation), primarily due to the diversity of its portfolio and higher dividend yield compared to BMY. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Newsweek

4 days ago

• Newsweek

Mexican Sewage Flooding Into California Can Be Seen From Space

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A NASA instrument aboard the International Space Station has detected contamination from Mexican sewage that spilled into the Pacific Ocean off the coast of Southern California. Why It Matters The Tijuana River flows from Mexico into California and drains into the Pacific Ocean, transporting millions of gallons of untreated sewage along with it. This long-standing issue has raised alarms over its impact on both public health and the environment. What To Know The instrument, known as the Earth Surface Mineral Dust Source Investigation (EMIT), was originally used to map minerals in desert regions but is now offering insights into water quality. In a recent study, EMIT was able to identify phycocyanin—a pigment found in cyanobacteria—within a massive wastewater plume off the mouth of the Tijuana River. A plume spreads out to sea in this image captured off San Diego by the Sentinel-2 satellite on March 24, 2023. A plume spreads out to sea in this image captured off San Diego by the Sentinel-2 satellite on March 24, 2023. SDSU/Eva Scrivner/NASA Cyanobacteria are an organism capable of causing illness in humans and animals through ingestion or inhalation, NASA said. EMIT operates by analyzing light reflected from Earth's surface, breaking it down into hundreds of visible and infrared color bands. Each material, including pollutants, has a unique spectral signature that allows scientists to identify it. Researchers matched EMIT's satellite data of the Tijuana River plume with results from ground-tested water samples. Both methods identified a spectral signature indicating the presence of phycocyanin. The findings come as Southern California beaches near the United States-Mexico border have repeatedly faced closures due to contamination. Millions of gallons of wastewater enter the Tijuana River annually, emptying into the ocean and posing a health hazard to swimmers and military personnel stationed in the area. San Diego County beaches have seen 1,000 days' worth of closures in recent years, and a report from the Department of Defense's Office of Inspector General documented 1,100 cases of illness among Navy SEALs and other service members exposed to polluted waters​. What People Are Saying Christine Lee, a scientist at NASA's Jet Propulsion Laboratory and a co-author of the study, said: "From orbit you are able to look down and see that a wastewater plume is extending into places you haven't sampled. "It's like a diagnostic at the doctor's office that tells you, 'Hey, let's take a closer look at this.'" Eva Scrivner, a doctoral student at the University of Connecticut and the study's lead author, said that the findings "show a 'smoking gun' of sorts for wastewater in the Tijuana River plume." What Happens Next Lee Zeldin, the administrator of the Environmental Protection Agency, stated in May that the U.S. International Boundary and Water Commission was expediting an expansion of the South Bay International Wastewater Treatment Plant, which treats sewage and wastewater from Tijuana, by 10 million gallons per day in an effort to mitigate the crisis.