Array BioPharma’s MEK/BRAF inhibitor combo handily beat out Roche’s Zelboraf on overall survival scores among a group of patients suffering from advanced melanoma with a BRAF mutation.
Already up for review at the FDA after posting positive progression-free survival data, the Boulder, CO-based company reported today that the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily — dubbed COMBO450 — produced a median OS of 33.6 months, doubling the 16.9 months recorded in the Zelboraf (vemurafinib) arm.
“Vemurafinib performed as expected,” Array CEO Ron Squarer told me in a preview of the release this morning. “COMBO450 was quite remarkable at three years. Just a few years ago expected survival was under a year. We’ve made tremendous progress.”
The PDUFA date is set for June 30, though the agency has a track record of sometimes speeding up its approvals for applications it feels strongly about. Squarer says the company has been busy laying the groundworks for a commercial rollout, and will be ready to roll in May.
While the new OS data may not be needed for the OK, it certainly won’t hurt the biotech’s commercial prospects.
Array’s investigational drug binimetinib has had a few ups and downs last year. In March, Array walked back plans to file an NDA after lackluster data in NRAS-positive melanoma diminished its prospects for approval, ahead of the combo success. More recently the biotech struck a deal with Pfizer $PFE to fund several cancer drug combo studies using the pharma giant’s PARP inhibitor talazoparib and the PD-L1 checkpoint avelumab.
Array is partnered with Pierre Fabre. Its stock price $ARRY jumped 11% Tuesday morning.
“We are excited to report these overall survival results from the COLUMBUS trial,” said Victor Sandor, the CMO at Array. “This encouraging overall survival finding further validates previously reported median progression-free survival and overall response rate results, and taken together with the attractive tolerability profile, these data suggest that the combination of encorafenib with binimetinib has the potential to become a promising new treatment option for these patients.”
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