Array BioPharma has yanked its NDA to the U.S. regulator for its late-stage melanoma candidate binimetinib after the agency told the biotech its phase 3 Nemo data wouldn’t cut it.
The med was seeking a licence to treat a rare form of this deadly skin cancer, known as NRAS-mutant melanoma, but after talks with the FDA about Nemo, Array said it: “Concluded that the clinical benefit demonstrated in the phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.” Its PDUFA date had been at the end of June this year.
These data, posted last summer, showed that the drug was not too much better than older chemotherapy med dacarbazine, where its objective response rate was 15% for binimetinib versus 7% for dacarbazine, while median overall survival was estimated at 11 months for the experimental med, but 10.1 months for chemo.
In the brief update, the biotech said that other, ongoing trials for binimetinib would continue, and that this wouldn’t hit its planned phase 3 combo trial, known as Columbus, where it will be paired with encorafenib.
This combo therapy is targeting another melanoma mutation, known as BRAF (and is already catered for by several Big Pharmas), “which remains on track for mid-2017,” and is seen as the biotech’s main future revenue driver.
Analysts at Leerink said in a note to clients that while NRAS-positive melanoma was only a small value driver for the company: “We think this comes as a surprise to investors and is a clear setback for the company and management’s regulatory and commercial strategy.”
The $1.75 billion market cap biotech was hit on the news premarket, with its shares down nearly 18%.