On Wednesday Arry Biopharma (ARRY) reported positive phase 3 results in patients with NRAS-mutant Melanoma. This phase 3 trial was known as the NEMO trial, which recruited 402 patients in total. The primary endpoint of the trial was to determine Progression-free Survival — PFS. There are no other FDA approved drugs used to treat this type of Melanoma. 

The trial met the primary endpoint of the drug Binimetinib, superior to the Dacarbazine treatment arm. The median PFS for the Binimetinib drug was conducted in a period of 2.8 months, and the Dacarbazine arm only 1.5 months. This means that Binimetinib was statistically significant compared to Dacarbazine , p-value of p < 0.001.

The company plans to submit an NDA for Binimetinib approval in the first half of 2016. The company is also currently running other phase 3 trials with its Binimetinib compound. The second phase 3 trial is known as the COLOMBUS trial targeting patients with BRAF-mutant Melanoma. The third phase 3 trial is known as the MILO trial and it is treating patients with low grade Ovarian Cancer. Binimetinib is also being studied in other earlier stage cancer trials. 

Shares of the company surged by 20% and considering it was a positive late-stage study I expect a further rise in share price over the coming weeks.

There can be further expected upside down the road if the other phase 3 trials are successful in their respective targets as well. 

Print Friendly, PDF & Email