Pfizer Reports Positive Results for Braftovi Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 hours ago
0mins
Should l Buy PFE?
Pfizer announced positive topline progression-free survival, or PFS, results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi - encorafenib - in combination with cetuximab - marketed as Erbitux - and Folfiri in patients with previously untreated metastatic colorectal cancer, or mCRC, with a BRAF V600E mutation. The Braftovi regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint vs. treatment with Folfiri with or without bevacizumab. Overall survival, a descriptive secondary endpoint, also showed clinically meaningful prolonged improvement with the Braftovi regimen. At the time of the PFS analysis, the safety profile of Braftovi in combination with cetuximab and Folfiri was consistent with the known profile of each regimen component and no new safety signals were identified. Braftovi in combination with cetuximab and Folfiri is an investigational regimen and is not currently approved. Braftovi in combination with cetuximab and mFOLFOX6 received accelerated approval by the FDA in December 2024 for patients with BRAF V600E-mutant mCRC. Continued approval for this indication is contingent upon verification of clinical benefit.
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Analyst Views on PFE
Wall Street analysts forecast PFE stock price to rise
16 Analyst Rating
5 Buy
11 Hold
0 Sell
Moderate Buy
Current: 27.580
Low
24.00
Averages
28.56
High
35.00
Current: 27.580
Low
24.00
Averages
28.56
High
35.00
About PFE
Pfizer Inc. is a research-based, global biopharmaceutical company. The Company is engaged in the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide. Its Biopharma segment includes the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division. Its product categories include oncology, primary care and specialty care. Its oncology products include Ibrance, Xtandi, Padcev, Adcetris, Inlyta, Lorbrena, Bosulif, Tukysa, Braftovi, Mektovi, Orgovyx, Elrexfio, Tivdak and Talzenna. Its primary care products include Eliquis, Nurtec ODT/Vydura, Zavzpret, the Prevnar family, Comirnaty, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix, Trumenba, and Paxlovid. Its specialty care products include Xeljanz, Enbrel (outside the United States and Canada), Inflectra, Abrilada, Cibinqo, Litfulo, Eucrisa, Velsipity, the Vyndaqel family, Genotropin, BeneFIX, Xyntha, Somavert, Ngenla, Hympavzi, Sulperazon, Zavicefta, Octagam and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Pfizer Reports Positive BREAKWATER Trial Results for BRAFTOVI
- Trial Results: Pfizer's BREAKWATER trial shows that the combination of BRAFTOVI with cetuximab and FOLFIRI significantly improves progression-free survival (PFS) in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), indicating a potential shift in treatment practices.
- Survival Rate Improvement: The overall survival (OS) also demonstrated clinically meaningful prolongation, further validating the efficacy of BRAFTOVI and potentially offering a new treatment option for previously untreated BRAF V600E-mutant mCRC patients, addressing a significant unmet need.
- Safety Profile: At the time of the PFS analysis, the safety profile of BRAFTOVI was consistent with known components, with no new safety signals identified, suggesting a favorable safety profile that enhances its clinical applicability.
- FDA Submission Plans: Pfizer plans to submit detailed results to the FDA to support the potential approval of BRAFTOVI in combination with cetuximab and FOLFIRI for BRAF V600E-mutant mCRC patients, further advancing the drug's market prospects.
See More
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- Survival Rate Improvement: The combination therapy also demonstrated a clinically meaningful benefit in overall survival among newly diagnosed patients with BRAF V600E-mutant metastatic colorectal cancer, reinforcing Braftovi's therapeutic potential in this challenging patient population.
- Safety Profile Consistency: No new safety signals were observed during the trial, and the tolerability of Braftovi combined with cetuximab and Folfiri remained consistent with established safety profiles of the individual treatments, validating the safety of this combination therapy.
- FDA Accelerated Approval: Pfizer plans to submit data from Cohort 3 of the BREAKWATER trial to seek FDA approval for the use of Braftovi in combination with cetuximab and Folfiri, further advancing the therapy's market application and potential impact on patient care.
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- Changing Competitive Landscape: As new drugs undergo clinical trials and enter the market, competition will intensify, particularly with companies like Eli Lilly leveraging their product portfolios to capture significant market share in the EU4 and Japan, showcasing strong market potential.
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- Patent Expiration Risks: Drug companies face challenges from patent expirations, with typical drug patents lasting 20 years; however, due to lengthy development times, effective market exclusivity often shrinks to just 10 to 12 years, necessitating continuous pipeline replenishment.
- Strategic Acquisition: Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on innovative drugs that manipulate genes and cells within patients, further solidifying its leadership in the lucrative GLP-1 drug category.
- Collaborative Development: Prior to the acquisition, Lilly entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, showcasing its strategic vision for global innovation in drug development.
See More
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- Pfizer Vaccine Impact: Pfizer's stock price surged from around $33 to nearly $60 in 2020 due to the rapid production and approval of its COVID-19 vaccine, but demand has since waned, leading to a drop to approximately $28, below pre-pandemic levels, highlighting the volatility in pharmaceutical demand.
- Patent Expiration Risks: Pharmaceutical companies face challenges from patent expirations, where the typical 20-year patent often results in only 10 to 12 years of effective market exclusivity due to lengthy development times, impacting long-term investment returns and competitive positioning.
- Eli Lilly Acquisition Moves: Eli Lilly recently announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on developing innovative drugs that treat diseases within the patient's body, demonstrating the company's proactive strategy in filling its drug pipeline and potentially driving future growth.
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See More
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- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
See More
Pfizer Reports Positive BREAKWATER Trial Results for BRAFTOVI
- Trial Results: Pfizer's BREAKWATER trial shows that the combination of BRAFTOVI with cetuximab and FOLFIRI significantly improves progression-free survival (PFS) in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), indicating a potential shift in treatment practices.
- Survival Rate Improvement: The overall survival (OS) also demonstrated clinically meaningful prolongation, further validating the efficacy of BRAFTOVI and potentially offering a new treatment option for previously untreated BRAF V600E-mutant mCRC patients, addressing a significant unmet need.
- Safety Profile: At the time of the PFS analysis, the safety profile of BRAFTOVI was consistent with known components, with no new safety signals identified, suggesting a favorable safety profile that enhances its clinical applicability.
- FDA Submission Plans: Pfizer plans to submit detailed results to the FDA to support the potential approval of BRAFTOVI in combination with cetuximab and FOLFIRI for BRAF V600E-mutant mCRC patients, further advancing the drug's market prospects.
See More
Pfizer's Braftovi Therapy Improves Colorectal Cancer Patient Survival
- Clinical Trial Success: Pfizer's Braftovi, in combination with cetuximab and Folfiri, significantly improved progression-free survival in colorectal cancer patients in Cohort 3 of the BREAKWATER trial, achieving a key secondary endpoint that underscores the therapy's clinical significance.
- Survival Rate Improvement: The combination therapy also demonstrated a clinically meaningful benefit in overall survival among newly diagnosed patients with BRAF V600E-mutant metastatic colorectal cancer, reinforcing Braftovi's therapeutic potential in this challenging patient population.
- Safety Profile Consistency: No new safety signals were observed during the trial, and the tolerability of Braftovi combined with cetuximab and Folfiri remained consistent with established safety profiles of the individual treatments, validating the safety of this combination therapy.
- FDA Accelerated Approval: Pfizer plans to submit data from Cohort 3 of the BREAKWATER trial to seek FDA approval for the use of Braftovi in combination with cetuximab and Folfiri, further advancing the therapy's market application and potential impact on patient care.
See More
Atopic Dermatitis Market Growth Insights
- Market Size Growth: The atopic dermatitis treatment market is expected to continue growing positively by 2034, with the United States holding the largest market share, reflecting strong demand for new therapies that drive overall market expansion.
- Introduction of New Therapies: The launch of new therapies such as Rocatinlimab and Amlitelimab is anticipated to transform the market landscape by providing more effective treatment options to meet the increasing patient demand.
- Rising Patient Numbers: In 2024, approximately 53 million diagnosed cases of atopic dermatitis are expected in the 7MM, with the increase in patient numbers directly fueling the demand for advanced treatment options and promoting market growth.
- Changing Competitive Landscape: As new drugs undergo clinical trials and enter the market, competition will intensify, particularly with companies like Eli Lilly leveraging their product portfolios to capture significant market share in the EU4 and Japan, showcasing strong market potential.
See More
Eli Lilly Acquires Orna Therapeutics to Enhance Drug Pipeline
- Market Volatility: Pfizer's stock surged from $33 to nearly $60 in 2020 due to rapid COVID-19 vaccine production, but after a significant drop in 2023, it now trades around $28, indicating the volatility in pharmaceutical demand.
- Patent Expiration Risks: Drug companies face challenges from patent expirations, with typical drug patents lasting 20 years; however, due to lengthy development times, effective market exclusivity often shrinks to just 10 to 12 years, necessitating continuous pipeline replenishment.
- Strategic Acquisition: Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on innovative drugs that manipulate genes and cells within patients, further solidifying its leadership in the lucrative GLP-1 drug category.
- Collaborative Development: Prior to the acquisition, Lilly entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, showcasing its strategic vision for global innovation in drug development.
See More
Investment Risks and Opportunities in the Pharmaceutical Industry
- Pfizer Vaccine Impact: Pfizer's stock price surged from around $33 to nearly $60 in 2020 due to the rapid production and approval of its COVID-19 vaccine, but demand has since waned, leading to a drop to approximately $28, below pre-pandemic levels, highlighting the volatility in pharmaceutical demand.
- Patent Expiration Risks: Pharmaceutical companies face challenges from patent expirations, where the typical 20-year patent often results in only 10 to 12 years of effective market exclusivity due to lengthy development times, impacting long-term investment returns and competitive positioning.
- Eli Lilly Acquisition Moves: Eli Lilly recently announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on developing innovative drugs that treat diseases within the patient's body, demonstrating the company's proactive strategy in filling its drug pipeline and potentially driving future growth.
- New Drug Development Partnerships: Eli Lilly also entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, further enhancing its competitive edge in the global market, although it was not recommended as a top investment by The Motley Fool.
See More
U.S. Medical Groups Sue CDC to Block Vaccine Advisory Meeting
- Lawsuit Initiated: Several medical groups, including the American Academy of Pediatrics and the American Public Health Association, filed a lawsuit on Friday to prevent the CDC from holding its next vaccine advisory meeting, arguing that the CDC's overhaul of immunization guidelines could jeopardize public health.
- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
See More
