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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 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 © 2025 Benzinga does not provide investment advice. All rights reserved. 登入存取你的投資組合
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4 days ago
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Pfizer's BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
Pivotal results from the Phase 3 BREAKWATER trial showed 51% risk reduction in death compared to standard-of-care treatment BRAFTOVI combination regimen also demonstrated 47% risk reduction in disease progression or death compared to standard-of-care treatment, meeting the trial's dual primary endpoint of progression-free survival First and only combination regimen with targeted therapy to improve survival outcomes for treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer NEW YORK, May 30, 2025--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These data will be presented today in an oral presentation (Abstract LBA3500) at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting and have been simultaneously 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; 95% Confidence Interval [CI], 0.38, 0.63, p<0.0001). Median OS was 30.3 months (95% CI, 21.7, Not Estimated) with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab (95% CI, 13.7, 17.7). 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; 95% CI, 0.41, 0.68, p<0.0001) as assessed by blinded independent central review (BICR). Median PFS was 12.8 months (95% CI, 11.2, 15.9) with the BRAFTOVI combination regimen compared to 7.1 months (95% CI, 6.8, 8.5). "Patients with metastatic colorectal cancer whose tumors harbor a BRAF V600E mutation generally face a daunting prognosis, as this aggressive tumor often does not respond well to standard-of-care chemotherapy," said Elena Élez, M.D., Ph.D., senior investigator at Vall d'Hebron Institute of Oncology in Barcelona, Spain, and co-principal investigator of the BREAKWATER trial. "The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant metastatic colorectal cancer in the first-line setting, representing a practice-changing breakthrough for patients." CRC is the third most common type of cancer in the world1 BRAF mutations are estimated to occur in 8-12% of people with mCRC and represent a poor prognosis.2 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in patients with CRC harboring this mutation is more than double that of patients with no known BRAF mutation present.2-4 "The BRAFTOVI combination helped significantly reduce the risk of disease progression or death, potentially altering the course of disease for people with metastatic colorectal cancer with a BRAF V600E mutation," said Johanna Bendell, M.D., Chief Oncology Development Officer, Pfizer. "These unprecedented results from the BREAKWATER trial further establish the benefit of the BRAFTOVI combination regimen and its potential to become a new standard-of-care, building on Pfizer's legacy in precision medicine and commitment to delivering breakthrough medicines that help people with cancer live better and longer lives." 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 (65.7%; 95% CI, 59.4, 71.4 and 37.4%; 95% CI, 31.6, 43.7, respectively). The estimated median duration of response and median time to response were also maintained from the prior primary analysis. Results from the primary analysis of ORR were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine in January 2025. Additional data from a separate arm of the BREAKWATER study evaluating BRAFTOVI in combination with cetuximab will also be presented at ASCO. "The risk of death for patients with BRAF V600E-mutant metastatic colorectal cancer is more than double compared to those with no known mutation," said Michael Sapienza, Chief Executive Officer, Colorectal Cancer Alliance. "These survival outcomes from the BREAKWATER study bring renewed hope to patients and their loved ones, providing the possibility of more time together. We are thrilled to see important cancer research propel us closer to our goal of ending this disease." At the time of this analysis, the safety profile of BRAFTOVI in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common side effects (≥30%) were nausea, anemia, diarrhea, decreased appetite, vomiting, neutrophil count decrease, arthralgia, and rash. Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 13.8% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI. 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.5 Continued approval for this indication is contingent upon verification of clinical benefit. The approval was among the first in the industry to be conducted under the FDA's Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease. The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language. Those interested in learning more can visit to access the summaries. About BREAKWATERBREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with mFOLFOX6 in participants with previously untreated BRAF V600E-mutant metastatic CRC. Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (control-arm) (n=243). The dual primary endpoints are ORR and progression-free survival (PFS) as assessed by blinded independent central review (BICR). Overall survival is a key secondary endpoint. About Colorectal Cancer (CRC)CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.6 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.6 In the U.S. alone, an estimated 154,270 people will be diagnosed with cancer of the colon or rectum in 2025, and approximately 53,000 are estimated to die from the disease each year.7 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.8 BRAF mutations are estimated to occur in 8-12% of people with mCRC and represent a poor prognosis for these patients.2 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in patients with CRC with the BRAF V600E mutation is more than double that of patients with no known BRAF mutation present.2-4 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.9,10 About BRAFTOVI® (encorafenib)BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC. Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea). INDICATION AND USAGEBRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is also indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC. IMPORTANT SAFETY INFORMATION Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for recommended dosing and additional safety information. WARNINGS AND PRECAUTIONS New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous, can occur. In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC) skin papilloma was reported in 2.6%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment. Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI. Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. Safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Hepatotoxicity: Hepatotoxicity can occur. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.2% for alkaline phosphatase, 1.3% for ALT, and 0.9% for AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Hemorrhage: In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%). In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 30% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), an increase of QTcF >500 ms was measured in 3.6% (8/222) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms. Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose. Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab, or in combination with cetuximab and mFOLFOX6. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for additional risk information. Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose. Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility. ADVERSE REACTIONS BREAKWATER Trial (previously untreated BRAF V600E mutation-positive mCRC) Serious adverse reactions occurred in 38% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (3.5%) and pyrexia (3.5%). Fatal gastrointestinal perforation occurred in 0.9% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were peripheral neuropathy (62% vs 53%), nausea (51% vs 48%), fatigue (49% vs 38%), rash (31% vs 4%), diarrhea (34% vs 47%), decreased appetite (33% vs 25%), vomiting (33% vs 21%), hemorrhage (30% vs 18%), abdominal pain (26% vs 27%), and pyrexia (26% vs 14%). Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were: increased lipase (51% vs 25%), decreased neutrophil count (36% vs 34%), decreased hemoglobin (13% vs 5%), decreased white blood cell count (12% vs 7%), and increased glucose (11% vs 2%). BEACON CRC Trial (previously treated BRAF V600E mutation-positive mCRC) Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%). Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab was pancreatitis. Most common laboratory abnormalities (all grades) (≥20%) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs 48%) and lymphopenia (24% vs 35%). DRUG INTERACTIONS Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose. Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers. Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations. Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval. View the full Prescribing Information. About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients' LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Disclosure NoticeThe information contained in this release is as of May 30, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and the BRAFTOVI® (encorafenib) plus cetuximab and mFOLFOX6 combination for the treatment of metastatic colorectal cancer (CRC) with a BRAF V600E mutation, including their potential benefits and discussions of the BREAKWATERsurvival data with regulatory authorities, including the FDA, to support potential conversion from accelerated approval to full approval for the combination regimen in this indication , that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BRAFTOVI plus cetuximab and mFOLFOX6; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when the accelerated approval for BRAFTOVI plus cetuximab and mFOLFOX6 for the treatment of patients with metastatic CRC with a BRAF V600E mutation will be converted to full approval in the U.S.; whether and when any drug applications may be filed in any additional jurisdictions for BRAFTOVI plus cetuximab and mFOLFOX6 for the treatment of patients with metastatic CRC with a BRAF V600E mutation or in any jurisdictions for any other potential indications for BRAFTOVI; whether and when any such other applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether BRAFTOVI plus cetuximab and mFOLFOX6 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI or BRAFTOVI plus cetuximab and mFOLFOX6; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and ERBITUX® is a registered trademark of Eli Lilly and Company its subsidiaries, or affiliates. References American Cancer Society. Global Cancer Facts & Figures 5th Edition. Available at: Last accessed: March 2025. Josep Tabernero et al., The Evolving Treatment Landscape in BRAF-V600E–Mutated Metastatic Colorectal Cancer. Am Soc Clin Oncol Educ Book 42, 254-263(2022). DOI:10.1200/EDBK_349561 Safaee Ardekani G, Jafarnejad SM, Tan L, et al. The prognostic value of BRAF mutation in colorectal cancer and melanoma: a systematic review and meta-analysis. PloS ONE. 2012;7(10):e47054. Schirripa M, Biason P, Lonardi S, et al. Class 1, 2, and 3 BRAF-Mutated Metastatic Colorectal Cancer: A Detailed Clinical, Pathologic, and Molecular Characterization. Clin Cancer Res. 2019;25(13):3954-3961. doi:10.1158/ Kopetz S, Yoshino T, Van Cutsem E, et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med. 2025;31(3):901-908. doi:10.1038/s41591-024-03443-3 American Cancer Society. Key Statistics for Colorectal Cancer. Available at: Last accessed: March 2025. American Cancer Society. Cancer Facts & Figures 2025. Available at: Last accessed: March 2025. Ciardiello F, Ciardiello D, Martini G, et al. Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin. 2022;72:372–40. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer. V.1.2025 © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 2025. To view the most recent and complete version of the guideline, go online to Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10–32. View source version on Contacts Media Contact:+1 (212) 733-1226PfizerMediaRelations@ Investor Contact:+1 (212) 733-4848IR@
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4 days ago
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Pfizer Inc. (PFE) Ends Acepodia Partnership Amid Depo-Provera Legal Woes
Pfizer Inc. (NYSE:PFE) is navigating a period of strategic upheaval and legal scrutiny as it ends its clinical collaboration with Acepodia and faces mounting lawsuits over its contraceptive, Depo-Provera. The decision to mutually terminate the partnership with Acepodia, which focused on autoimmune disease drug development, is attributed to PFE's global resource prioritization and not to Acepodia's capabilities. The wind-down is expected to have no impact on Acepodia's clinical programs, with both companies leaving open the possibility of future collaboration. Pixabay/Public Domain Simultaneously, Pfizer Inc. (NYSE:PFE) is embroiled in multidistrict litigation involving approximately 400 lawsuits alleging the company failed to adequately warn about the risk of brain tumors linked to long-term Depo-Provera use. Recent studies have intensified scrutiny, and hearings are scheduled as the company faces accusations of prioritizing profits over patient safety. Despite these challenges, Pfizer Inc. (NYSE:PFE)'s performance has remained stable, mirroring broader market trends. However, investor sentiment is cautious: the company's total shareholder return fell 11.11% over the past year, underperforming the US pharmaceuticals sector's 10.5% decline. Analysts note that the current share price reflects these uncertainties, with only a marginal upside projected, underscoring the importance of future earnings and revenue growth for PFE's outlook. While we acknowledge the potential of PFE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than PFE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
The Star
26-05-2025
- Business
- The Star
Long-term bond yields surge around the world
WASHINGTON: Around the world, yields on longer-dated sovereign debt have soared as investors question the ability of governments to cover massive budget deficits. In the United States, 30-year bond yields last week approached levels last seen in 2007 as President Donald Trump's tax bill is poised to swell the budget deficit. Those in Japan exceeded the highest on record in data since 1999, with auctions in both countries drawing tepid demand. Long-dated bonds in Britain, Germany and Australia also faced selling pressure. Meanwhile, banks in China lowered their benchmark lending rates for the first time in seven months, and Australia's central bank cut its key interest rate for a second time this year in a bid to mitigate the impact of US tariffs. Meanwhile, a pullback by central banks and pension funds from bond markets has marginalised a once-dependable source of funding. The giants of corporate America, from Pfizer Inc to Alphabet Inc, are borrowing in euros like never before as the anxiety triggered by Trump's tariff threats pushes them to hunt for alternative funding avenues in case their home market freezes up. In addition to the decisions by Australian and Chinese banks, Iceland, Jamaica, Sri Lanka, Egypt and Indonesia lowered rates. Officials in Angola, Nigeria, Zambia, Ghana and Paraguay kept borrowing costs unchanged. The detection of bird flu in a single poultry farm in southern Brazil is reverberating around the world, cutting supplies to voracious consumers from China to Europe. Shipments to top destinations, which also include Mexico and South Korea, have been suspended as the world's largest chicken exporter seeks to stop the deadly H5N1 strain from spreading. China, a dominant force in batteries and electric vehicle manufacturing, is also the undisputed leader in critical minerals refining – a position it has leveraged to retaliate against Trump's tariffs. Strategic concerns have preoccupied Beijing for decades, well before the United States and other Western nations began fretting about access to key metals and the fragility of industrial supply chains. On a corporate campus in north-west Taiwan, a rushed effort to bolster the island's defences against China is taking shape – with little help from the technology giants who turned this outpost into a global chipmaking hub. The military officials entering and exiting a factory run by Coretronic Intelligent Robotics Corp – located just kilometres from the beaches where Beijing's forces would land in an invasion – underscore the firm's role at the heart of Taiwan's homegrown efforts to arm itself with aerial drones. China imported the most gold in nearly a year last month despite record prices after heightened demand for the precious metal prompted the central bank to ease restrictions on bullion inflows. The rise in imports is likely due to the People's Bank of China allocating fresh quotas to some commercial banks in April, as the authority responds to strong demand from institutional and retail investors at the height of the trade war. Europe UK inflation jumped more than forecast to its highest rate in over a year as households were hit by a raft of price increases, prompting investors to pare bets on rate cuts from the Bank of England (BoE). Services inflation, watched closely by the BoE for signs of underlying price pressures, accelerated to 5.4% from 4.7%. Private-sector activity in the euro area unexpectedly shrank in May as services recorded their worst performance in 16 months. Bulgaria is close to clearing a major hurdle toward euro adoption, putting the Black Sea nation on course to join the currency area next year. US Chinese shipments of Apple Inc's iPhone and other mobile devices to the United States dived to their lowest levels since 2011 in April, underscoring how the threat of US tariffs choked off the flow of big-ticket goods between the world's two largest economies. US businesses are under mounting pressure to import goods while Trump's higher tariffs are on pause, and they're simultaneously navigating increasingly complex filing rules when their cargo crosses the border. Mexico's annual inflation accelerated more than expected early this month in a report that likely won't deter central bankers from cutting interest rates again in June, given the economy also posted weak growth. Argentina's economy grew less than expected in March as the country braced for a new programme with the International Monetary Fund. South America's second-largest economy has been showing consistent signs of momentum after two quarters of contraction exacerbated by austerity policies in the first half of 2024. — Bloomberg
Business Mayor
25-05-2025
- Business
- Business Mayor
Charting the Global Economy: US biz under pressure to import during tariff pause
In the US, 30-year bond yields this week approached levels last seen in 2007 as President Donald Trump's tax bill is poised to swell the budget deficit. Those in Japan exceeded the highest on record in data since 1999, with auctions in both countries drawing tepid demand. Long-dated bonds in the UK, Germany and Australia also faced selling pressure. Meanwhile, banks in China lowered their benchmark lending rates for the first time in seven months and Australia's central bank cut its key interest rate for a second time this year in a bid to mitigate the impact of US tariffs. Here are some of the charts that appeared on Bloomberg this week on the latest developments in the global economy, markets and geopolitics: World Investors are warning that governments can't keep borrowing at the pace they did when interest rates were close to zero, particularly since trade tensions and sticky inflation have diminished the probability that policymakers will dramatically ease monetary policy. Meanwhile, a pullback by central banks and pension funds from bond markets has marginalised a once-dependable source of funding. The giants of corporate America from Pfizer Inc. to Alphabet Inc. are borrowing in euros like never before as the anxiety triggered by Trump's tariff threats pushes them to hunt for alternative funding avenues in case their home market freezes up. In addition to the decisions by Australia and Chinese banks, Iceland, Jamaica, Sri Lanka, Egypt and Indonesia lowered rates. Officials in Angola, Nigeria, Zambia, Ghana and Paraguay kept borrowing costs unchanged. The detection of bird flu in a single poultry farm in southern Brazil is reverberating around the world, cutting supplies to voracious consumers from China to Europe. Shipments to top destinations, which also include Mexico and South Korea, have been suspended as the world's largest chicken exporter seeks to stop the deadly H5N1 strain from spreading. Read More May bank holiday: Supermarket opening times from Tesco to Aldi Asia A dominant force in batteries and EV manufacturing, China is also the undisputed leader in critical minerals refining, a position it's used to retaliate against Trump's tariffs. Strategic concerns have preoccupied Beijing for decades, well before the US and other Western nations began fretting about access to key metals and the fragility of industrial supply chains. On a corporate campus in northwest Taiwan, a rushed effort to bolster the island's defenses against China is taking shape — with little help from the technology giants who turned this outpost into a global chipmaking hub. The military officials entering and exiting a factory run by Coretronic Intelligent Robotics Corp. — located just miles from the beaches where Beijing's forces would land in an invasion — underscore the firm's role at the heart of Taiwan's homegrown efforts to arm itself with aerial drones. China imported the most gold in nearly a year last month despite record prices, after heightened demand for the precious metal prompted the central bank to ease restrictions on bullion inflows. The rise in imports is likely due to the People's Bank of China allocating fresh quotas to some commercial banks in April, as the authority responds to strong demand from institutional and retail investors at the height of the trade war. Europe UK inflation jumped more than forecast to its highest rate in over a year as households were hit by a raft of price increases, prompting investors to pare bets on rate cuts from the Bank of England. Services inflation, watched closely by the BOE for signs of underlying price pressures, accelerated to 5.4% from 4.7%. Private-sector activity in the euro area unexpectedly shrank in May as services recorded their worst performance in 16 months. Bulgaria is close to clearing a major hurdle toward euro adoption, putting the Black Sea nation on course to join the currency area next year. US Chinese shipments of Apple Inc.'s iPhone and other mobile devices to the US dived to their lowest levels since 2011 in April, underscoring how the threat of US tariffs choked off the flow of big-ticket goods between the world's two largest economies. US businesses are under mounting pressure to import goods while Trump's higher tariffs are on pause, and they're simultaneously navigating increasingly complex filing rules when their cargo crosses the border. Emerging Markets Mexico's annual inflation accelerated more than expected early this month in a report that likely won't deter central bankers from cutting interest rates again in June given the economy also posted weak growth. Argentina's economy grew less than expected in March as the country braced for a new program with the International Monetary Fund. South America's second-largest economy has been showing consistent signs of momentum after two quarters of contraction exacerbated by austerity policies in the first half of 2024.
