Dive Brief:
- On Tuesday, Array BioPharma Inc. and Pierre Fabre Corp. announced results from a planned analysis of the COLUMBUS trial, which is evaluating a combination treatment of two drugs the company's are co-developing: encorafenib and binimetinib.
- In the Phase 3 study, patients treated with binimetinib 45 had median overall survival of 33.6 months, close to double the 16.9 months observed among patients dosed with Roche's Zelboraf. Patients treated with encorafenib alone had a median overall survival between the two, at 23.5 months.
- When paired together, encorafenib and binimetinib lowered the risk of death compared with Zelboraf with a hazard ratio of 0.61. The New Drug Applications for encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma have a target action date of June 30. Array's shares rose 15% over the course on Feb. 6, climbing further the following day.
Dive Insight:
Metastatic melanoma has low survival rates, and around half the cases of melanoma have the BRAF mutation. Roche's Zelboraf (vemurafenib), approved in 2011 for late-stage melanoma, is a key treatment, but Array's combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib doubled down on the approved drug in COLUMBUS, with a median survival of twice as long. Array's combo also has the potential advantage that it is designed to reduce the risk of resistance.
"This data suggests that the combination of encorafenib and binimetinib may have the potential to become a meaningful new therapy for patients with advanced BRAF-mutant melanoma," said Keith Flaherty, director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital Cancer Center, in a Feb. 6 statement.
The other key competitor to Array's combo is Novartis AG's combination of Tafinlar (dabrafenib) and Mekinist (trametinib), which has also been shown to improve overall survival. The potential approval in June for Array could rattle the market for both Roche and Novartis.
Array's two-drug combo is also under review in melanoma with the European Medicines Agency, the Swiss Medicines Agency and the Australian Therapeutic Goods Administration. Array is working on the combo with Pierre Fabre in Europe, Asia and Latin America, and with Ono Pharmaceutical Co. Ltd. in Japan and Korea. Encorafenib and binimetinib are also being studied in Phase 3 with Eli Lilly & Co.'s Erbitux (cetuximab) in BRAF-mutant colorectal cancer.