Array Biopharma Inc (NASDAQ:ARRY) and Pierre Fabre today jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone.
“The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the combination of binimetinib plus encorafenib versus vemurafenib in patients with BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “We look forward to working with global regulatory authorities as they evaluate our planned submission.”
In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib (“combination”) was 14.9 months versus 7.3 months for patients treated with vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. The combination was generally well-tolerated and reported adverse events were overall consistent with previous combination encorafenib plus binimetinib clinical trial results in BRAF-mutant melanoma patients.
“The preliminary results from Part 1 of COLUMBUS suggest that the combination of encorafenib plus binimetinib represents a potentially unique therapy for the BRAF-mutant melanoma population,” said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School. “In addition to the robust activity observed in Part 1, the combination appeared to be generally well-tolerated.”
Analysis of a secondary endpoint comparing the PFS of patients treated with combination to patients treated with encorafenib showed a median of 14.9 months versus 9.6 months with HR (0.75), [95% CI 0.56-1.00], p=0.051, which did not reach statistical significance. A complete analysis of these results will be provided to global regulatory authorities as part of planned submissions. In addition, data from Part 2 of the COLUMBUS trial are anticipated in mid 2017 and will also be provided to global health authorities as part of planned regulatory submissions for approval of these product candidates.
Further results from Part 1 of the COLUMBUS trial, including objective response rates, disease control rates, safety endpoints, exploratory analyses such as a Part 1 PFS comparison of encorafenib to vemurafenib and pre-specified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at an upcoming medical meeting. Analysis of the secondary endpoint of overall survival (OS) was not planned as part of these initial results.
Frédéric Duchesne, Chief Executive Officer Pharmaceutical Division, Pierre Fabre remarked, “We are very pleased with the COLUMBUS Part 1 results and look forward to the possibility that, if approved, the combination of encorafenib plus binimetinib could offer a new treatment option for patients suffering from this devastating disease.” (Original Source)
Shares of Array Biopharma jumped nearly 56% to $5.70 in early trading Monday. ARRY has a 1-year high of $5.57 and a 1-year low of $2.39. The stock’s 50-day moving average is $3.53 and its 200-day moving average is $3.38.
On the ratings front, ARRY stock has been the subject of a number of recent research reports. In a report issued on August 31, Suntrust Robinson Humphrey analyst Peter Lawson reiterated a Buy rating on ARRY, with a price target of $7.00, which represents a potential upside of 50.5% from where the stock is currently trading. Separately, on August 30, Leerink Swann’s Michael Schmidt reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Peter Lawson and Michael Schmidt have a total average return of 10.7% and 25.1% respectively. Lawson has a success rate of 56% and is ranked #439 out of 4183 analysts, while Schmidt has a success rate of 68% and is ranked #34.
The street is mostly Bullish on ARRY stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $7.00, which represents a potential upside of 50.5% from where the stock is currently trading.
Array BioPharma Inc. is a biopharmaceutical company, which focuses on the discovery, development, and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Its proprietary drug development pipeline focuses on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important targets. It also collaborates with pharmaceutical and biotechnology companies under which the firm has out-licensed certain proprietary drug programs for further research, development, and commercialization.