Pfizer's (PFE.US) Braftovi therapy trial has achieved remarkable success, with over 60% of colorectal cancer patients responding positively to the treatment.

Pfizer (PFE.US) announced on Saturday that its colorectal cancer treatment Braftovi (encorafenib) showed significant clinical effects in a late-stage trial, shrinking tumors. The New York-based pharmaceutical giant said that the combination drug based on Braftovi showed safety consistent with previous trials of its components after it released data from its third phase BREAKWATER trial.

Its detailed results showed that the objective response rate of Braftovi combination therapy was 61%, with both clinical and statistical significance, compared with 40% for chemotherapy patients. In addition, the median duration of response for Braftovi combination therapy was 13.9 months, while that for chemotherapy was 11.1 months.

BREAKWATER will evaluate the objective response rate as a double primary endpoint. The trial is ongoing to assess overall survival (secondary endpoint) and progression-free survival (double primary endpoint), with the latter data expected to be released this year.

Braftovi is an oral small molecule kinase inhibitor, and Pfizer sells the drug in Japan and South Korea with Ono Pharmaceutical. The drug received accelerated approval from the FDA in December for the treatment of metastatic colorectal cancer (mCRC) with BRAF V600E mutation.

The BREAKWATER trial is designed to evaluate Braftovi in combination with Eli Lilly's (LLY.US) colorectal cancer treatment drug ERBITUX, with or without another cancer treatment regimen called mFOLFOX6, for the treatment of newly diagnosed BRAF V600E mutation-positive mCRC patients.