Encorafenib

iStock, Marut Khobtakhob Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year. Pfizer arrived in Chicago this weekend for the American Society of Clinical Oncology’s annual conference fresh off a $10.5 billion deal with China’s Innovent Biologics, as the company seeks to bolster its oncology pipeline. “It is not a big [ASCO] year from the vantage-point of stock-moving data,” Leerink Partners analyst David Risinger told BioSpace . “The focus is looking forward to the Pfizer readouts ahead.” Risinger noted that the company’s most anticipated updates from an investor standpoint are set for later this year. The New York pharma giant showcased data across more than 40 abstracts at ASCO 2026, plus three late-breakers and several oral presentations. All told, the data ranged from striking, long-term results for approved drugs to previews of what’s coming, including some assets out of China. “We want to go big and make impact,” Johanna Bendell, Pfizer’s chief development officer of oncology, told BioSpace prior to the conference. China Pfizer bets up to $10.5B in 12-candidate cancer collab with China’s Innovent Pfizer continues its dealmaking spree by striking a back-heavy partnership with China’s Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer. May 29, 2026 · 2 min read · Tristan Manalac Read more Wins in lung, colorectal and prostate cancer In its late-breaking abstracts, Pfizer presented new data for drugs already in clinic, cementing them as strong treatment options or providing evidence for their use in earlier-stage disease. The company on Friday shared updated data from its Phase 3 CROWN trial , comparing ALK inhibitor Lobrena to its earlier-generation oral kinase inhibitor Xalkori in patients with previously untreated, ALK-positive advanced non-small cell lung cancer (NSCLC). At seven years, patients taking Lobrena saw an 81% drop in the risk of disease progression or death. These patients had a 55% likelihood of being alive without disease progression, compared to just 3% of those in the control arm. Overall survival (OS) data is not yet available, Bendell said. Pfizer is hoping to see this metric within the next year. “The durability of the benefit is unlike any trial we’ve seen,” Sarah Goldberg, chief of thoracic oncology at Yale Cancer Center, told BioSpace . “The CROWN data have looked good for a long time, but as we get longer-term follow-up, I think it’s more convincing that this should be our choice for first-line treatment.” Meanwhile, Bendell, who previously treated patients with gastrointestinal cancers, is particularly excited about new results from BREAKWATER . The trial evaluates Pfizer’s BRAF inhibitor Braftovi plus Eli Lilly’s Erbitux and the FOLFIRI chemotherapy regimen for previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer, compared to FOLFIRI with or without bevacizumab. FOLFIRI and FOLFOX are common chemo regimens for patients with colorectal cancer, and earlier BREAKWATER data showed strong benefit for Braftovi plus Erbitux and mFOLFOX6. The FDA granted Braftovi full approval in first-line metastatic colorectal cancer in February. In this latest readout from BREAKWATER, the Braftovi/FOLFIRI combo also cut the risk of progression or death, this time by 56%, and PFS nearly doubled to 15.2 months versus 8.3 months in the comparator arm. Risk of death also declined by 44%, according to Pfizer’s Monday press release . “You can choose whichever of the chemotherapy backbones. You’re still going to have a significant impact by bringing Braftovi in for these patients,” Bendell said. Meanwhile, adding Pfizer’s PARP inhibitor Talzenna to the company’s Xtandi resulted in better outcomes for men with HHR-altered metastatic castration-sensitive prostate cancer, according to results from the Phase 3 TALAPRO-3 trial . The combination resulted in a 52% reduction in risk of radiographic progression or death, compared to placebo plus Xtandi. At three years, some 77% of patients on the combination still had radiographic PFS (rPFS), compared to 56% of those in the control arm. The results from TALAPRO-3 could move the combination earlier into the disease course, before castration resistance, Bendell said. “The earlier you move the therapy, the more impact that you can have for patients.” The results could help support the growth of Talzenna going forward, as Xtandi is soon set to face generic competition, Risinger said, adding that those were very important results. A look ahead—and a patent cliff Elsewhere at ASCO, Pfizer unveiled new data from assets designed to be the future of its oncology business. One such drug is the company’s CDK4 inhibitor atirmociclib, the heir apparent to its blockbuster breast cancer drug Ibrance, which loses patent protection next year. Breast cancer Pfizer’s Ibrance Heir Reduces Risk of Death in Phase 2 Breast Cancer Test Pfizer has a lofty goal for the CDK4 inhibitor atirmociclib, the New York pharma’s answer to Ibrance’s loss of patent protection next year. In 2025, Ibrance led Pfizer’s oncology portfolio with $1.04 billion in sales. March 17, 2026 · 1 min read · Annalee Armstrong Read more The Phase 2 FourLight-2 trial evaluated neoadjuvant atirmociclib plus letrozole vs. letrozole alone among 121 patients with HR+/HER2- breast cancer. Based on Ki-67 biomarker data, the proportion of patients taking atirmociclib who achieved complete cell cycle arrest at two weeks was 88.2% compared to 17.9% in the comparator group. Patients on atirmociclib also had more side effects, with nearly 20% experiencing diarrhea. The efficacy was compelling, but the gastrointestinal toxicity is a key question going forward, Risinger said . Pfizer also put up data in the competitive PD-1/VEGF bispecific antibody space, where Summit Therapeutics and its Chinese biopharma partner Akeso made headlines with their candidate ivonescimab. BioNTech and Bristol Myers Squibb also presented solid data for their asset pumitamig. Immuno-oncology ASCO: Summit reached with China lung data but new climb begins to prove global benefit “King Keytruda’s reign continues,” analysts at BMO Capital Markets declared after Chinese data for Summit Therapeutics’ ivonescimab were revealed at the American Society for Clinical Oncology in Chicago. June 1, 2026 · 3 min read · Annalee Armstrong Read more In updated results from a Phase 2 trial of Pfizer’s bispecific PD-1/VEGF antibody SSGJ-707 (PF’4404), the confirmed objective response rate was 75.0% for patients with squamous-cell NSCLC and 63.6% for non-squamous cell NSCLC, with a median PFS of 8.9 months and 12.4 months, respectively. “The data were encouraging, but the jury is still out with respect to which agents will differentiate,” Risinger said. The compound also showed promise in endometrial cancer in a different Phase 2 trial . Among 29 patients with advanced or recurrent endometrial cancer, the confirmed objective response rate was 85.7% at a 5-mg/kg dose and 80.0% at 10 mg/kg. Pfizer paid $1.25 billion upfront to license the bispecific from 3SBio in 2025, and the company has since launched 12 clinical trials in the program and plans to start five more. As for key upcoming data, Risinger pointed to several readouts, including one around the middle of this year for Pfizer’s investigational antibody-drug conjugate (ADC) sigvotatug vedotin (SV) versus docetaxel in second-line NSCLC. Last week, Pfizer amended the primary endpoint to OS only, with the change likely to mildly increase the chance of success, analysts at BMO Capital Markets wrote in a note to investors last Wednesday. PFS will now be a descriptive secondary endpoint, the firm noted. “While such a change reduces our confidence in the robustness of PFS, OS remains the highest importance in NSCLC, making this change rationale for increasing SV’s chances to demonstrate clinically meaningful results,” the analysts wrote. “SV is expected to be a blockbuster for NSCLC,” Risinger said. Also awaited in the second half of 2026 are results from the Phase 3 MEVPRO-1 trial , evaluating the EZH2 inhibitor mevrometostat plus enzalutamide in patients with previously treated metastatic castration-resistant prostate cancer. Plus, this upcoming weekend, Phase 2 data will be presented for Pfizer’s monthly, long-acting injectable GLP-1 that it acquired from Metsera at the 2026 American Diabetes Association ’s Scientific Sessions, as the company builds out its obesity assets. As Risinger said, “there’s a broad pipeline at Pfizer that is needed to offset the patent cliffs ahead.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

Cohort 3 analysis from the Phase 3 BREAKWATER study showed a 56% reduction in the risk of disease progression or death compared to traditional chemotherapy regimen Overall survival benefit was also observed, with a 44% reduction in the risk of death BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy is the only approved targeted regimen for BRAF V600E-mutant metastatic colorectal cancer NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced detailed progression-free and overall survival results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These results will be presented today in a late-breaking oral presentation (Abstract LBA3503) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Annals of Oncology . As previously reported , Cohort 3 met its primary endpoint of objective response rate (ORR) by blinded independent central review (BICR). Results for the key secondary endpoint of progression-free survival (PFS) by BICR, being presented at ASCO, show median PFS was nearly doubled with the BRAFTOVI combination regimen (15.2 months) versus the comparator (8.3 months). A clinically meaningful and statistically significant 56% reduction in the risk of disease progression or death was observed for patients treated with the BRAFTOVI combination regimen versus the comparator (Hazard Ratio [HR] of 0.44; 95% Confidence Interval [CI], 0.27–0.70; p=0.0002). Updated overall survival (OS), a descriptive secondary endpoint, showed a 44% reduction in the risk of death for patients treated with the BRAFTOVI combination regimen versus the comparator (HR of 0.56; 95% CI, 0.34–0.94) with a median follow-up of approximately 20 months for both arms. At 18 months, 72% of patients receiving the BRAFTOVI combination regimen were expected to be alive compared to 54.5% of patients receiving the comparator. Median OS was not reached for the BRAFTOVI combination regimen versus a median of 20.3 months for the comparator. “For people with BRAF V600E-mutant metastatic colorectal cancer – a disease that historically has had no targeted treatment options and poor outcomes – these results strengthen confidence in how we can treat this disease,” said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “A nearly 60% reduction in risk of disease progression or death, combined with prolonged overall survival, reinforces the role of encorafenib in combination with cetuximab and FOLFIRI as a standard of care in the first-line setting for this patient population.” "These compelling results add to a robust body of evidence demonstrating the efficacy of the BRAFTOVI combination treatment across two different established chemotherapy regimens in BRAF V600E-mutant metastatic colorectal cancer,” said Jeff Legos, Chief Oncology Officer, Pfizer. “These findings reaffirm the established role of the BRAFTOVI combination regimen as a cornerstone of first-line treatment for patients and families facing this challenging diagnosis.” In this Cohort 3 analysis, the safety pro BRAFTOVI in combination with cetuximab and FOLFIRI continued to be consistent with the known safety pro each respective agent in the regimen, and no new safety signals were identified. The most common adverse events (AEs) (≥25%) in the BRAFTOVI regimen were nausea, diarrhea, vomiting, anemia, alopecia, fatigue, decreased neutrophil count, constipation, decreased appetite, neutropenia, arthralgia, asthenia, and abdominal pain. Grade ≥3 AEs (all causality) occurred in 70.4% of patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI compared to 80.9% of patients receiving FOLFIRI with or without bevacizumab. Treatment discontinuation occurred in 15.5% of patients receiving the BRAFTOVI combination compared to 10.3% for those receiving FOLFIRI. Based on the totality of the Phase 3 and Cohort 3 data in the BREAKWATER study, BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy received full approval with an expanded indication from the U.S. Food and Drug Administration (FDA) for patients with BRAF V600E-mutant mCRC in February 2026, offering flexibility in chemotherapy regimen used. 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 BREAKWATER BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in participants with previously untreated BRAF V600E-mutant mCRC. 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, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint. In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control-arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS as assessed by BICR is a key secondary endpoint; OS is a 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. 2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women. 2 In the U.S. alone, an estimated 158,850 people will be diagnosed with cancer of the colon or rectum in 2026, and approximately 55,000 are estimated to die from the disease each year. 3 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. 4 BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients. 5 The BRAF V600E mutation is the most common BRAF mutation, and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present. 5-7 Despite the high unmet need in BRAF V600E - mutant mCRC, prior to the BRAFTOVI accelerated FDA approval in this indication on December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E - mutant mCRC. 8,9 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 USAGE BRAFTOVI ® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. 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 and FOLFIRI for recommended dosing and additional safety information. WARNINGS AND PRECAUTIONS New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, 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%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. 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 noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous 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-authorized 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 multig