Pfizer (PFE) said Saturday that its Phase 3 BREAKWATER study showed a 61% objective response rate for the BRAFTOVI combination therapy in patients with BRAF V600E-mutant metastatic colorectal cancer, compared to 40% for standard chemotherapy, based on an independent review.
The BRAFTOVI treatment, which includes cetuximab and mFOLFOX6, has been approved by the FDA for newly diagnosed patients with this mutation, the company stated.
Patients treated with the BRAFTOVI combination had a median response duration of 13.9 months, compared to 11.1 months for those receiving normal chemotherapy, while early overall survival data showed favorable results for the new treatment, Pfizer added.
Pfizer said the safety profile of the BRAFTOVI combination was in line with the known effects of the individual treatments.
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