(Reuters) - Array BioPharma Inc said its experimental drug helped patients with a form of skin cancer live longer without their cancer progressing, in an ongoing late-stage study.
The company’s stock jumped as much as 36 percent in heavy trading on the Nasdaq on Wednesday.
Data showed that patients with advanced NRAS-mutant melanoma treated with the drug, binimetinib, lived for a median of 2.8 months before their disease worsened, compared with 1.5 months for patients treated with the chemotherapy dacarbazine.
So far, there have been no drugs approved to specifically treat this mutation.
Array is the first, and likely the only company developing an agent specifically to target this difficult-to-treat population - at least for the foreseeable future, Chief Executive Ron Squarer told Reuters.
The Boulder, Colorado-based biotechnology company in March regained the rights to the compound from Novartis AG. It had granted the Swiss drugmaker the license to develop and market binimetinib in 2010. (bit.ly/1B7hRoH)
In a research note published last month, Wells Fargo’s Matthew Andrews noted that former partner Novartis had originally designed the study expecting the drug to improve progression-free survival to roughly 4 months compared to dacarbazine.
Nearly 74,000 new cases of melanoma and nearly 10,000 deaths from the disease are projected for 2015, according to Array. NRAS mutations occur in about 15 to 20 percent of patients whose disease has advanced, which roughly translates into an addressable global population of 6,000-8,000 patients per year.
On average, those with the stubborn mutation live an average of 8.5 months once diagnosed.
Detailed results from the 402 patient trial “NEMO”, which included patients who had first tried immunotherapy and those that not been previously treated, will be presented at a medical meeting next year.
This data will determine what utility the drug has in both categories of patients, which in turn will shape Array’s marketing application for NRAS melanoma, Squarer said.
He declined to provide any details on pricing.
The drug is also being tested in separate late-stage studies in patients with BRAF-mutant melanoma and ovarian cancer.
Array on Wednesday said it plans to submit an application to market binimetinib to treat NRAS-mutant melanoma in the first half of 2016. If all goes well, the drug could hit the U.S. market by the end of next year or early 2017, the company said.
The company’s shares were up 22 percent at $4.68 in midday trade.
Reporting by Natalie Grover in Bengaluru; Editing by Shounak Dasgupta
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