Array BioPharma Inc. (ARRY - Free Report) , along with its partner Pierre Fabre, announced positive top-line data from part 1 of the phase III study, COLUMBUS, on a combination of encorafenib (BRAF inhibitor) and binimetinib (MEK inhibitor) for the treatment of BRAF-mutant advanced, unresectable or metastatic melanoma.
Array BioPharma’s shares gained 81.1% on the news and hit a new 52-week high of $6.65 on Sep 26, before closing a little lower at $6.61.
Results of the study showed that the combination significantly improved progression-free survival (PFS) in comparison to Roche Holding AG’s (RHHBY - Free Report) Zelboraf (vemurafenib) alone, thereby meeting the primary endpoint. Moreover, the combination was generally well tolerated and adverse events were consistent with the previous studies. However, the study failed to meet the secondary endpoint.
Meanwhile, data from the part II of the COLUMBUS study are expected in mid 2017. Results from the two parts will be submitted to regulatory authorities next year.
According to the American Cancer Society, it has been estimated that about 76,000 new cases of melanoma are expected to occur in the U.S. in 2016. Out of this, approximately 10,000 will die from the disease. The market for MEK/BRAF combination agents has high potential, with global annual sales expected to reach $1 billion worldwide.
Note that a New Drug Application (NDA) for binimetinib for the treatment of patients with advanced NRAS-mutant melanoma is currently under review in the U.S. The FDA has provided a Prescription Drug User Fee Act (PDUFA) of Jun 30, 2017.
Apart from melanoma, the encorafenib-binimetinib combination is also being evaluated in patients with advanced cancer. Currently, Array is evaluating encorafenib, in combination with Eli Lilly and Company’s (LLY - Free Report) Erbitux (cetuximab), with or without binimetinib, in the phase III BEACON CRC study in patients with BRAF V600E-mutant colorectal cancer. The study is being conducted under a Special Protocol Assessment (SPA) with the FDA. Patient enrollment is expected to be complete in 2018.
Array currently carries a Zacks Rank #3 (Hold).
A Stock to Consider
Corcept Therapeutics Incorporated (CORT - Free Report) is a better-ranked stock in the health care sector, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. The company witnessed an increase of 25% and 12.5% in its earnings estimates for 2016 and 2017, respectively, in the last 60 days. It has posted a positive earnings surprise thrice in the last four quarters, bringing the average beat to 100%. Corcept’s shares have surged 39.5% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>