Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%
Pfizer Inc. (NYSE:PFE) on Friday released data from Phase 3 BREAKWATER trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
The study showed statistically significant and clinically meaningful survival results.
The data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.In a second interim analysis of overall survival (OS), a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab (Hazard Ratio [HR] 0.49).
Median OS was 30.3 months with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab.
In the primary analysis of progression-free survival (PFS), the BRAFTOVI combination regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab (HR 0.53) as assessed by blinded independent central review (BICR).
Median PFS was 12.8 months with the BRAFTOVI combination regimen compared to 7.1 months.
The updated objective response rate (ORR) by BICR confirmed the improvement previously observed with the BRAFTOVI combination regimen compared to patients receiving chemotherapy with or without bevacizumab.
The prior primary analysis also maintained the estimated median duration of response and median time to response.
The BRAFTOVI combination regimen received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, the study's other dual primary endpoint.
Continued approval for this indication is contingent upon verification of clinical benefit.
The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025.
Price Action: PFE stock is up 0.51% at $23.57 at the last check on Friday.
Read Next:Photo via Shutterstock
Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.
Get the latest stock analysis from Benzinga?
PFIZER (PFE): Free Stock Analysis Report
This article Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50% originally appeared on Benzinga.com
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
登入存取你的投資組合
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
an hour ago
- Business Upturn
OGN FRAUD ALERT: Organon & Co. Investors are Reminded of Ongoing Securities Fraud Class Action — Contact BFA Law by July 22 Legal Deadline (NYSE:OGN)
NEW YORK, June 22, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting Investors have until July 22, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Organon securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned: Hauser v. Organon & Co., et al. , No. 25-cv-05322. Why was Organon Sued for Securities Fraud? Organon is a global healthcare company focused on women's health that has historically rewarded its shareholders with a healthy dividend. In October 2024, Organon completed a $1.2 billion acquisition of Dermavant, a biopharmaceutical company focused on dermatological conditions. As alleged, while the acquisition increased Organon's debt, the Company assured investors it would maintain its dividend, which Organon asserted was its '#1 capital allocation priority.' In truth, Organon had shifted its capital allocation priority after the Dermavant acquisition to focus on reducing its debt, ultimately leading the Company to severely cut its dividend. The Stock Declines as the Truth is Revealed On May 1, 2025, Organon announced that management reset the Company's dividend payout from $0.28 per share to $0.02 per share. Organon's CEO explained that the Company 'reset our capital allocation priorities to accelerate progress towards deleveraging' and that '[b]y deleveraging more rapidly, we will continue to strengthen the future prospects of the company.' Organon's CFO added, '[t]he biggest issues we face . . . relate to managing our leverage and relate to growth. And we need capital to solve both of those issues, and so returning capital to shareholders is right now, less of a priority.' On this news, the price of Organon stock declined roughly 27%, from $12.93 per share on April 30, 2025, to $9.45 per share on May 1, 2025. Click here if you suffered losses: What Can You Do? If you invested in Organon you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212-789-3619
Business Upturn
an hour ago
- Business Upturn
RDDT FRAUD ALERT: Reddit, Inc. Investors are Reminded of Ongoing Securities Fraud Class Action — Contact BFA Law by August 18 Legal Deadline (NYSE:RDDT)
NEW YORK, June 22, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Reddit, Inc. (NYSE: RDDT) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in Reddit, you are encouraged to obtain additional information by visiting: Investors have until August 18, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Reddit securities. The case is pending in the U.S. District Court for the Northern District of California and is captioned Tamraz, Jr. v. Reddit, Inc., at al. , No. 25-cv-05144. Why was Reddit Sued for Securities Fraud? Reddit owns and operates the eponymous social news aggregation, forum, and social media platform. Reddit receives a significant portion of its user traffic from individuals seeking answers to questions using Google Search. The complaint alleges that Reddit misrepresented and downplayed the impact that Google's use of Artificial Intelligence ('AI') technology in Google's search results had on Reddit's user growth. In truth, Google's use of AI dented Reddit's user growth by eliminating the need for individuals to visit and click through to Reddit to get answers to their questions. Rather, the answers appeared through Google's AI search results. The Stock Declines as the Truth is Revealed On May 1, 2025, Reddit reported a significant slowdown in daily active user growth. On this news, the price of Reddit stock declined $4.96 per share, or more than 4%, from $118.79 per share on May 1, 2025, to $113.83 per share on May 2, 2025. Then, on May 21, 2025, Wall Street analyst Baird cut its Reddit stock price target over concerns that Google's AI capabilities are stifling Reddit's user growth. On this news, the price of Reddit stock fell $9.79 per share, or over 9%, from $105.64 per share on May 20, 2025, to $95.85 per share on May 21, 2025. Click here for more information: What Can You Do? If you invested in Reddit you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212-789-3619
Business Upturn
an hour ago
- Business Upturn
CIVI FRAUD ALERT: Civitas Resources, Inc. Investors are Reminded of Ongoing Securities Fraud Class Action — Contact BFA Law by July 1 Legal Deadline (NYSE:CIVI)
NEW YORK, June 22, 2025 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Civitas Resources, Inc. (NYSE: CIVI) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in Civitas you are encouraged to obtain additional information by visiting Investors have until July 1, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Civitas securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned Lin v. Civitas Resources., et al. , No. 25-cv-03791. Why was Civitas Sued for Securities Fraud? Civitas is an oil and gas exploration and production company with its key assets located in the Denver-Julesburg Basin in Colorado and the Permian Basin in Texas and New Mexico. The complaint alleges that Civitas stated that both basins had 'enhanced recovery potential' and that it had 'driven production ahead of plans,' while touting 'enhanced margins through reduced operating costs' and insisting that 'costs are below expectations.' In truth, the Company's oil production peaked in 2024, and increasing production would require Civitas to spend significant capital to acquire additional land, driving up costs. The Stock Declines as the Truth is Revealed On February 24, 2025, Civitas announced disappointing Q4 and full year 2024 results, and reduced its oil production guidance. The Company explained that oil production had peaked and it would need to spend hundreds of millions of dollars to acquire thousands of acres of new land to produce more oil. Civitas also announced that it was implementing a 10% reduction in its workforce to 'solidify the Company's low-cost structure.' On the same day, Civitas announced the immediate firings of its Chief Operating Officer and Chief Transformation Officer. On this news, the price of Civitas stock declined more than 18%, from a closing price of $49.30 per share on February 24, 2025, to $40.35 per share on February 25, 2025. Click here if you suffered losses: What Can You Do? If you invested in Civitas you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact:Ross Shikowitz [email protected] 212-789-3619
