Array Biopharma Inc (NASDAQ:ARRY) and its partner Pierre Fabre took the opportunity at the Society for Melanoma Research Annual Congress to share results for its COLUMBUS Phase 3 trial of binimetinib as a treatment for BRAF-mutant melanoma patients.
The aim of the study was to evaluate the efficacy and safety of Array’s candidate binimetinib as a combination treatment with another compound called encorafenib. As such, the trial was conveniently dubbed bini/enco study and as Array reported, the outcome was impressive and it hopes to bring the drug to market soon.
The study outcome
Array said bini/enco met the primary endpoint for both efficacy and safety. As for efficacy, the company said patients who received the combination treatment registered significant improvement in progression free survival (PFS) compared to the group of patients who received treatment of vemurafenib alone. Keep in mind vemurafenib is a BRAF inhibitor.
The median PFS (or mPFS) for patients who received bini/enco treatment was 14.9 months compared with 7.3 months for patients who received vemurafenib treatment.
Safety profile
Although patients who received bini/enco exhibited adverse events (AEs), Array reported the combination drug was generally well-tolerated. Furthermore, the adverse events were consistent with those noted in earlier clinical trials, thus raising no alarm for the safety profile of the drug.
Some 921 patients participated in the two-party study.
With the robust late-stage clinical results, Array is gearing up to submit the trial data for regulatory review in 2017. If successful, the drug could significantly boost Array’s financial performance.
F1Q17 earnings
Array posted EPS loss of $0.20 in the September quarter, or its F1Q17, beating the consensus estimate by $0.02. Revenue of $39.27 million rose sharply by more than 142% and easy beat the consensus estimate by nearly $7 million.
Array stock rose more than 7.4% in the last session to close at $6.51 despite the widespread scare in the stock markets following surprise victory of Donald Trump in the U.S. election. The stock is up more than 54% YTD.
