▎WuXiEdited by Kant Content Team
Pfizer, Inc. announced today in the Phase 3 clinical trial BREAKWATER, targetingBRAFPatients with V600E-mutated metastatic colorectal cancer (mCRC),The combination therapy consisting of Braftovi (encorafenib), cetuximab (brand name Erbitux), and the mFOLFOX6 regimen (including fluorouracil, leucovorin, and oxaliplatin) achieved positive preliminary results in the progression-free survival (PFS) analysis. According to an assessment by a Blinded Independent Central Review (BICR), the PFS in the combination therapy group showed a statistically significant and clinically meaningful improvement compared to patients treated with chemotherapy (with or without bevacizumab).Moreover, this combination therapy also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint — overall survival (OS).
Braftovi Combination Therapy Received U.S. FDA Approval in December 2024Accelerated Approval, used to treat carriers ofBRAFFor treatment-naïve mCRC patients with V600E mutation, the approval was based on the confirmed objective response rate (ORR) achieving statistically significant and clinically meaningful improvement in the study.The ORR was 61% in the group treated with Braftovi in combination with Erbitux and mFOLFOX6, compared to 40% in the group treated with chemotherapy alone or in combination with bevacizumab (p=0.0008).The median duration of response (DoR) in the combination therapy group was 13.9 months, compared to 11.1 months in the chemotherapy alone or chemotherapy plus bevacizumab group.Pfizer will share these latest results with the FDA to potentially support the Braftovi combination therapy treatment.BRAF Full approval for mCRC patients with V600E mutation.Colorectal cancer (CRC) is the third most common cancer globally, with approximately 1.8 million new cases in 2022, and it is also the second leading cause of cancer-related deaths. Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women. Among patients diagnosed with CRC, about 20% of cases have already metastasized or spread, making treatment more challenging, and up to 50% of patients with localized disease will eventually develop metastatic disease.▲To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long-press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.
References:
[1] Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial. Retrieved February 3, 2025, from https://www.businesswire.com/news/home/20250202068351/en
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