Pfizer: BRAFTOVI Combination Regimen Shows Significant Improvement In PFS In Phase 3 Trial In MCRC

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(RTTNews) - Drug major Pfizer Inc. (PFE) announced Monday positive topline results from the progression-free survival or PFS analysis of the Phase 3 BREAKWATER study of BRAFTOVI (encorafenib) Combination Regimen.

BRAFTOVI in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer or mCRC harboring a BRAF V600E mutation showed a statistically significant and clinically meaningful improvement in PFS.

PFS, one of the trial's dual primary endpoints, was assessed by blinded independent central review (BICR), compared to patients receiving chemotherapy with or without bevacizumab.

Further, the BRAFTOVI combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint in the trial.

BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. The company noted that inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

The company noted that the BRAFTOVI combination regimen received accelerated approval by the U.S. Food and Drug Administration in December 2024 to treat nave patients with BRAFV600E-mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed objective response rate or ORR, the study's other dual primary endpoint.

The ORR results 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.

Roger Dansey, Chief Oncology Officer, Pfizer, said, "The BRAFTOVI regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation. We look forward to discussing these data with global health authorities to bring this treatment to more patients around the world, as soon as possible."

The approval of the BRAFTOVI combination regimen was conducted under the FDA's Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease.

Pfizer said it will share the latest results with the FDA to potentially support full approval for BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with mCRC with a BRAF V600E mutation.

Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Further, Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison in Israel and Pierre Fabre Laboratories in all other countries, including Europe and Asia (excluding Japan and South Korea).

In pre-market activity on the NYSE, Pfizer shares were trading at $26.31, down 0.79 percent.

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