Pfizer Inc. (PFE) has reported encouraging outcomes from the Phase 3 BREAKWATER study assessing the efficacy of BRAFTOVI (encorafenib) used alongside cetuximab (known in the market as ERBITUX) and the chemotherapy regimen mFOLFOX6 (comprising fluorouracil, leucovorin, and oxaliplatin) in treating patients with metastatic colorectal cancer (mCRC) possessing a BRAF V600E mutation.
The Phase 3 trial data reveal that the combination therapy with BRAFTOVI achieved an objective response rate of 61%, compared to a 40% response rate with the investigator’s preferred chemotherapy regimen, effectively doubling the likelihood of achieving a positive response to treatment.
According to the assessment by BICR, the median duration of response was estimated at 13.9 months for the group receiving BRAFTOVI along with cetuximab and mFOLFOX6. This is in contrast to 11.1 months for those treated with chemotherapy, with or without bevacizumab. Furthermore, 22.4% (n=15) of patients on the BRAFTOVI regimen experienced a response extending beyond 12 months, compared to just 11.4% receiving the alternative chemotherapy. The median time to response as per BICR's evaluation was 7.1 weeks with the BRAFTOVI combination and 7.3 weeks with the comparator chemotherapy regimen.
Pfizer has highlighted that although the overall survival data were not mature at the time of analysis, they suggest a favorable trend for the BRAFTOVI combination compared to chemotherapy with or without bevacizumab. Median overall survival for the BRAFTOVI group remains unspecified but was reported as 14.6 months for the comparator group. The BREAKWATER trial is continuing to evaluate overall survival as well as progression-free survival, with further results expected in 2025.
The material has been provided by InstaForex Company - www.instaforex.com
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