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.
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.