Array Biopharma stock got a bounce out of the upbeat assessment of the second part of its Phase III study of binimetinib combined with encorafenib, demonstrating their ability to significantly improve progression free survival rates for patients with BRAF-mutant advanced melanoma. The top-line results lay the foundation for an NDA, the company adds, which is expected to be delivered to the FDA this summer.
Array’s shares $ARRY surged 20% on Wednesday as investors and analysts got a chance to consider the data on the MEK/BRAF inhibitors. And while some of the analysts covering the biotech felt that the Phase III news was a definite plus, there was a feeling that a subsequently announced partnership with Merck involving Keytruda — in which the pharma giant will simply contribute a quantity of their checkpoint drug for a study — was a bit of a letdown after speculation that a money deal was in the works.
In Phase III part 2, investigators looked at a combination of 45 mg binimetinib twice daily plus 300 mg encorafenib daily against the control arm of 300 mg encorafenib alone. The combination achieved a better median PFS — 12.9 months vs. 9.2 months; HR = 0.77.
The surge in the stock price helped repair some of the damage done a couple of months ago when CEO Ron Squarer had to walk back a promise that they had the data needed for its first approval of binimetinib for NRAS-positive melanoma.
Noted Leerink’s Michael Schmidt:
Given the positive outcome of COLUMBUS trial Part 1 & 2, the likelihood of approval of the binimetinib/encorafenib combination in mid-2018 remains high which was expected by most investors.
Part 1 was a 3-arm trial design in 577 patients with a 450 mg encorafenib dose combined with binimetinib compared to Zelboraf. The median PFS rate for Array’s combo was 14.9 months vs. 7.3 months.
Schmidt was less impressed with Array’s deal with Merck to combine binimetinib with Keytruda for colorectal cancer in an early study to test its potential.
While this is incrementally positive for ARRY, we think a potential deal (or even a buy-out of ARRY) was widely expected by investors.
“The totality of the COLUMBUS results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of binimetinib plus encorafenib as an attractive treatment option for patients diagnosed with BRAF-mutant melanoma,” said Keith T. Flaherty, director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,400+ biopharma pros who read Endpoints News by email every day.Free Subscription