Array BioPharma Inc.'s (ARRY - Free Report) shares increased more than 15% on Feb 6 after it announced encouraging overall survival (OS) data from a pivotal phase III study evaluating COMBO450, a combination medicine of binimetinib and encorafenib. Array along with partner Pierre Fabre have developed the combo therapy for treating patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
Notably, this combined regime is under review in both the United States and the EU for the aforementioned indication. A response from the FDA is expected on Jun 30, 2018. It was accepted for review based on encouraging progression-free survival data from the phase III study reported in September 2016.
Array’s shares have outperformed the industry in a year’s time. The stock has soared 54.6% compared with the industry’s increase of 0.2% in the same time frame.
The phase III COLUMBUS study is designed to examine the efficacy and safety of the combination therapy compared with Roche Holding AG's (RHHBY - Free Report) Zelboraf (vemurafenib) alone on BRAF-mutant melanoma patients. Data from the trial demonstrated a median OS of 33.6 months for patients treated with COMBO450 in comparison to 16.9 months for patients treated with vemurafenib as a monotherapy. This OS finding complements the median progression-free survival and overall response rate results, reported previously.
This combination cure was generally well tolerated during the study, which is in line with the outcomes reported earlier.
Array at present also evaluates encorafenib in collaboration with Eli Lilly and Company’s (LLY - Free Report) Erbitux (cetuximab) with or without binimetinib in the phase III BEACON CRC program on patients with BRAF V600E-mutant colorectal cancer. This study is being performed under a Special Protocol Assessment by the FDA. Patient enrollment for the same is awaited be completed in 2018.
We remind investors that Array had regained development and commercialization rights to binimetinib from Novartis Pharma AG (NVS - Free Report) back in March 2015.
It is important to note that French pharmaceutical company, Pierre Fabre Medicament SAS holds the right to commercialize binimetinib and encorafenib in Europe, Asia and Latin America. Whereas Array retains exclusive rights to commercialize both the drugs in the key markets namely the United States, Canada and Israel. Again, Ono Pharmaceutical, possesses exclusive rights to the products across Japan and South Korea.
Per the press release, around 200,000 new cases of melanoma are diagnosed each year, globally. Of this, approximately 50% has BRAF mutations, a key target in treating metastatic melanoma. Hence, approval of this combo therapy is likely to provide the company with access to a potentially strong and huge market.
In a separate press release, the company also announced its earnings of second-quarter fiscal 2018, reporting a loss of 17 cents per share, narrower than the Zacks Consensus Estimate of a loss of 23 cents.
The company reported revenues of $42.2 million, down 5.2% year over year. However, the top line surpassed the Zacks Consensus Estimate of $25 million. Both the releases drove the company's shares together.
Array carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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