Latest news with #Arvinas
Yahoo
an hour ago
- Business
- Yahoo
Full Arvinas, Pfizer data confirm potential and limits of ‘Protac' drug in breast cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental breast cancer drug from Arvinas and partner Pfizer modestly slowed disease progression in people whose tumors had changes to a specific gene, but did not provide a clear benefit to others who lacked that mutation. Full study results set to be presented Saturday at the American Society of Clinical Oncology's annual meeting provide a clearer picture of the drug's potential — and its limitations — than were available in March, when the companies shared an overview of trial outcomes. While the findings suggest the drug, an oral pill called vepdegestrant, may be a new option for a subset of breast cancer patients, they likely mean its use will remain narrow, should it win an approval. In their Phase 3 trial, Arvinas and Pfizer tested vepdegestrant against the injectable drug fulvestrant in 624 people who had the most common type of advanced breast cancer — tumors positive for estrogen receptors but negative for a protein called HER2. Trial participants had been treated before with hormone therapy and another type of drug known as a CDK4/6 inhibitor. Two-hundred and seventy participants had mutations in the ESR1 gene, which is known to help tumors develop resistance to treatment. The detailed data unveiled Saturday show vepdegestrant extended progression-free survival in people with ESR1 mutations by a median of five months, compared to 2.1 months for those on fulvestrant. Among study participants overall, however, median progression-free survival was similar: 3.8 months on vepdegestrant versus 3.6 months on fulvestrant. PFS measures the time from a treatment response to when either disease progression or death. Speaking in a briefing with reporters ahead of ASCO, Jane Lowe Meisel, co-director of breast medical oncology at the Winship Cancer Institute of Emory University School of Medicine, described vepdegestrant as an 'exciting option.' Yet she noted in a statement how 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Fulvestrant, the drug Arvinas and Pfizer tested vepdegestrant against, is a common treatment for advanced breast cancers that are hormone receptor positive and HER2 negative. The drug, which has been on the market for over two decades, blocks growth signaling to tumors through those hormone receptors. But the therapy has drawbacks, such as monthly intramuscular injections and a range of side effects. Vepdegestrant works differently. The oral drug is what's known as a proteolysis-targeting chimera, or PROTAC. It is designed to break down estrogen receptors, thereby cutting off the signals that promote tumor growth. To date, vepdegestrant is the first PROTAC to advance through Phase 3 testing, and the first of its type to tested in people with advanced breast cancer. Study researchers also measured overall survival but data on that score remain 'immature.' Essentially, too few people have died in the trial to draw conclusions about the statistical differences between the vepdegestrant and fulvestrant groups. Side effects for both treatments were common. Just over one-fifth of participants taking vepdegestrant experienced side effects that were rated severe or life-threatening, compared to 17.6% on fulvestrant. More participants on vepdegestrant — 2.9% — stopped treatment due to side effects at 2.9%, compared to 0.7% among those on fulvestrant. While vepdegestrant held no apparent benefit among the overall population, the drug could still hold promise for breast cancer patients with the ESR1 mutation. Such a role would be valuable as treating ESR1-mutated breast cancer remains challenging. Research led by Memorial Sloan Kettering Cancer Center researchers a decade ago found ESR1 mutations change the shape of the estrogen receptor in such a way that keeps pushing the cancer to grow, even in the absence of an estrogen signal. ESR1 mutations are estimated occur in approximately 40% to 50% of patients who undergo first-line therapy for metastatic breast cancer. Testing for the mutation is now done regularly, but typically occurs only after cancer has progressed or returned. It's become more prevalent since the approval of Orserdu, which is cleared for use in people with ER-positive, HER2-negative breast cancer that is positive for ESR1 mutations. Pfizer and Arvinas in March said they will share data from their study with health regulators in support of potential drug approval applications. But since then, the companies have scaled back their development of vepdegestrant, removing plans for two other Phase 3 trials. Arvinas also cut one-third of its staff. Recommended Reading Arvinas gets positive breast cancer data, but finds differentiation a hard sell
Reuters
2 hours ago
- Business
- Reuters
Pfizer-Arvinas breast cancer drug tops AstraZeneca's in delaying progression
May 31 (Reuters) - An experimental treatment by Pfizer (PFE.N), opens new tab and Arvinas (ARVN.O), opens new tab delayed progression of breast cancer by more than three months compared to AstraZeneca's (AZN.L), opens new tab Faslodex in patients with a specific gene mutation, according to trial results announced on Saturday. The findings were presented in Chicago at the annual meeting of the American Society of Clinical Oncology and published in The New England Journal of Medicine. The trial found the experimental drug vepdegestrant increased survival without progression of the disease in patients with ESR1 mutations by five months, compared to about two months for Faslodex. The findings followed initial results of the study in March. Those showed the benefit of vepdegestrant in patients with the mutations but failed to show benefit in a larger set of patients, sending Arvinas' shares to a record low. Saturday's more detailed data showed vepdegestrant increased survival in the larger group of patients by 3.8 months, versus 3.6 months for Faslodex. The late-stage study enrolled 624 previously treated patients with a type of breast cancer that accounts for nearly 70% of all such cancers. Erica Hamilton, one of the authors of the study, said that Faslodex "clearly has some challenges now," adding that it is injected into a muscle, versus vepdegestrant's more convenient oral dosing. Vepdegestrant belongs to a novel class of drugs called PROTAC ER degraders, which are designed to harness the body's natural protein disposal system to specifically target and degrade proteins that spur tumor growth. Breast cancer accounts for about one-third of all new female cancers each year in the U.S., according to the American Cancer Society. Approved treatments for this type of advanced breast cancer include Eli Lilly's (LLY.N), opens new tab Verzenio, Pfizer's Ibrance and Novartis' (NOVN.S), opens new tab Kisqali. Leerink Partners analyst Andrew Berens expects vepdegestrant to earn $576 million in peak sales in 2032. Earlier this month, Arvinas said that it will not move forward with two other planned late-stage studies of the drug.
Yahoo
2 days ago
- Business
- Yahoo
Pfizer and Arvinas gamble to shift breast cancer treatment paradigm
Breast cancer (BC) is the most prevalent cancer among women globally with two million diagnosed cases each year. Oestrogen receptor (ER) is expressed in most invasive BC cases (70 to 80%). Many therapies have therefore been developed to target this receptor, including fulvestrant, and more recently the CDK4/6 inhibitors, which act synergistically with endocrine therapies. But following exposure to endocrine and CDK4/6 inhibitor therapy, many patients quickly acquire ER mutations (ESR1m), leading to treatment resistance and leaving a significant unmet need. Pfizer's and Arvinas' vepdegestrant is an oral proteolysis-targeting chimera (PROTAC) ER degrader. The drug exploits the ubiquitin-proteasome system, degrading the mutant ER complex and greatly slowing growth and increasing tumour survivability. As the drug drives degradation and more specific targeting than small-molecule ER inhibitor receptors in preclinical studies, this class could leave a more profound effect with a tolerable safety profile. In the Phase II VERITAC trial, the drug was well-tolerated in a heavily CDK4/6 inhibitor pre-treated BC patient setting. Of 35 patients receiving 200mg of vepdegestrant, there was only one discontinuation and no dose reductions. A press release by Arvinas announced the results from the Phase III trial, VERITAC-2. Significant improvements to progression-free survival were seen with a hazard ratio of 0.60 in the ESR1m patient subpopulation for patients receiving vepdegestrant monotherapy compared to fulvestrant. This improvement was not seen in the overall population, including non-ESR1m patients. These patients had previously experienced progression following CDK4/6 inhibitor treatment. The full trial results are to be announced on 31 May at the 2025 American Society of Clinical Oncology conference. While initial safety and efficacy results are positive, the recent controversy surrounding the efficacy of CDK4/6 inhibitors in improving overall survival for breast cancer patients will hurt sales and the growth of the market share accessible to vepdegestrant. Regardless, the projected impact of vepdegestrant is suspected to be strong for the ESR1m population, which currently affects up to 39% of endocrine-resistant metastatic BC cases. GlobalData's analyst consensus forecasts estimate the drug to reach $1.64 billion in sales for metastatic breast cancer by 2031. "Pfizer and Arvinas gamble to shift breast cancer treatment paradigm" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
3 days ago
- Business
- Business Wire
Kirby McInerney LLP is Investigating Potential Shareholder Claims Against Arvinas, Inc. (ARVN)
NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP reminds investors that the firm is investigating potential claims against Arvinas, Inc. ('Arvinas' or the 'Company') (NASDAQ:ARVN). The firm's ongoing investigation concerns whether Arvinas and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices. On May 1, 2025, Arvinas and its partner Pfizer announced that they would discontinue development of vepdegestrant, an oral SERD for HR-positive breast cancer. The move eliminated two planned Phase 3 studies, following the termination of VERITAC-3 in January. According to The Fly, a financial news platform, Oppenheimer & Co. 'was surprised by the announcement' and questioned whether 'Arvinas' management isn't telling us the whole story.' Arvinas had repeatedly pointed to clinical progress for vepdegestrant and the drug's commercial opportunity, leaving investors caught off guard by the abrupt pivot. On this news, the price of Arvinas shares declined by $2.39 per share, or approximately 25%, from $9.62 per share on April 30, 2025, to close at $7.23 on May 1, 2025. If you purchased or otherwise acquired Arvinas securities, have information, or would like to learn more about this investigation, contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@ or fill out the contact form below to discuss your rights or interests with respect to these matters without any cost to you. [CONTACT FORM] Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Yahoo
02-05-2025
- Business
- Yahoo
Here are 1 Main Capital Partners' Views on Arvinas (ARVN)
1 Main Capital, a boutique investment firm, released its first-quarter 2025 investor letter. A copy of the letter can be downloaded here. The fund returned (3.6)% net in the first quarter compared to (4.3)% and (9.5)% for the S&P 500 (SPX) and Russell 2000 (RTY). Since its inception in February 2018, the fund has returned annualized net returns of 19.5%, compared to 11.9% and 4.8% for the indexes. In addition, you can check the fund's top 5 holdings to find out its best picks for 2025. In its first-quarter 2025 investor letter, 1 Main Capital highlighted stocks such as Arvinas, Inc. (NASDAQ:ARVN). Arvinas, Inc. (NASDAQ:ARVN) is a clinical-stage biotechnology company. The one-month return of Arvinas, Inc. (NASDAQ:ARVN) was 4.78%, and its shares lost 77.71% of their value over the last 52 weeks. On May 1, 2025, Arvinas, Inc. (NASDAQ:ARVN) stock closed at $7.23 per share with a market capitalization of $527.728 million. 1 Main Capital stated the following regarding Arvinas, Inc. (NASDAQ:ARVN) in its Q1 2025 investor letter: "Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotech company developing targeted protein degraders, is down more than 90% from its 2021 highs due to investor disappointment with its trials. A biopharma executive in a meeting room discussing the clinical-stage of a new therapy. Arvinas, Inc. (NASDAQ:ARVN) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 32 hedge fund portfolios held Arvinas, Inc. (NASDAQ:ARVN) at the end of the fourth quarter, compared to 34 in the third quarter. While we acknowledge the potential of Arvinas, Inc. (NASDAQ:ARVN) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. In another article, we covered Arvinas, Inc. (NASDAQ:ARVN) and shared the list of stocks under $10 that will triple. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: Michael Burry Is Selling These Stocks and A New Dawn Is Coming to US Stocks. Disclosure: None. This article is originally published at Insider Monkey.
