Array up by more than half on PhIII melanoma combo data


Array BioPharma ($ARRY) was up about 57% in early trading on top-line Phase III data for its combo of two investigational skin cancer candidates. The study met its progression-free survival endpoint (PFS), in which the combination of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK162 (binimetinib) offered improved PFS versus Genentech’s BRAF inhibitor Zelboraf (vemurafenib) alone.

The second part of the Phase III study, known as COLUMBUS, has data due in mid-2017; that’s anticipated to offer the basis for regulatory submissions for approval for this combo and has a similar primary endpoint. The indication is specifically for BRAF-mutant advanced, unresectable or metastatic melanoma.

Array has already submitted an NDA for binimetinib to treat NRAS-mutant melanoma, which the FDA has accepted with a June 30, 2017, review date.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

Binimetinib and encorafenib are partnered by Array with Pierre Fabre under a $455 million deal that dates back to November 2015. That deal came about after Novartis ($NVS) ended a collaboration with Array around the assets; the pharma was still on the hook to fund the ongoing trials to completion.

"The preliminary results from Part 1 of COLUMBUS suggest that the combination of encorafenib plus binimetinib represents a potentially unique therapy for the BRAF-mutant melanoma population," said Dr. Keith Flaherty, Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, said in a statement. "In addition to the robust activity observed in Part 1, the combination appeared to be generally well-tolerated."

A secondary endpoint of PFS for encorafenib treated patients did not reach statistical significance, but data for the combination are expected to take primacy with the FDA.

“Both the secondary endpoint reported today and COLUMBUS Part 2 are designed to provide evidence to allow for the review or the satisfaction of what's generally known as the combination rule,” said Array CEO Ron Squarer on a conference call about the data.

He continued, “And what we are aware of both from the regulations as well as precedence is that the regulators specifically, the FDA often look at a broad range of sources in order to address this question and certainly the information we will provide, but there are certainly precedence for them to look at both the other clinical and non-clinical sources of evidence in order to answer this question.”

Array hit a market cap of about $830 million on the news.

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its "Star Trek"-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.