Pfizer Shares Gain on Promising Late-Stage Cancer Trial Data

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Pfizer has reported encouraging top-line results from a key late-stage clinical trial, BREAKWATER, evaluating its cancer therapy BRAFTOVI (encorafenib). The focus of the study is a combination treatment for a specific patient population: those with previously untreated metastatic colorectal cancer (mCRC) who have a BRAF V600E mutation. The central finding is a measurable benefit in slowing the progression of the disease.

The pharmaceutical giant now plans to discuss the complete data set with the U.S. Food and Drug Administration (FDA) and is considering filing for regulatory approval of this regimen as an initial treatment for this patient subgroup.

The positive data emerged from Cohort 3 of the global Phase 3 BREAKWATER study. Patients received a combination of BRAFTOVI, cetuximab (marketed as ERBITUX), and the chemotherapy regimen FOLFIRI.

• Primary Result: The treatment showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS). PFS measures the length of time during and after treatment that a patient lives with the disease but it does not get worse.
• Assessment: This critical secondary endpoint was evaluated through a blinded, independent central review, a method that strengthens the reliability of the result.
• Safety Profile: Investigators reported no new safety signals, with the combination's safety profile aligning with the known risks of the individual components.

Path to Potential First-Line Approval

Following these results, Pfizer's immediate next step is to engage with the FDA. The company will submit the detailed BREAKWATER findings and explore a regulatory application to establish the BRAFTOVI-based combination as a first-line standard of care for BRAF V600E-mutant metastatic colorectal cancer.

Existing Approval and Context

BRAFTOVI already holds an accelerated approval in the United States for use in mCRC, but under different conditions. It is approved in combination with cetuximab and the chemotherapy mFOLFOX6 for treatment-nae patients, and with cetuximab alone for previously treated patients. Pfizer notes that the continued approval for these existing indications may be contingent upon verification of clinical benefit in confirmatory trials.

The submission of the BREAKWATER data therefore represents a pivotal moment, potentially allowing Pfizer to formally position this combination therapy as a leading initial treatment option for this defined genetic subset of colorectal cancer patients.