Array Biopharma Inc (NASDAQ:ARRY) has published the detailed results of phase 3 Columbus trial of the new formulations Binimetinib and Encorafenib in patients with metastatic melanoma or unselectable and mutant advanced disease on March 21, 2018.
The median free progression survival of the patients treated with a combination of Binimetinib (45 mg daily) and Encorafenib (450 mg daily) is reported to be around 14.9 months when compared to the 7.3 months in patients treated with 960 mg of vemurafenib (daily twice).
According to the Director at Massachusetts General Hospital Cancer Center, Dr. Keith T. Flaherty, M.D., the 15 months of median progression free survival for the patients (suffering from advanced BRAF-mutant metastatic melanoma) treated with a combination of Binimetinib and Encorafenib is clinically meaningful.
An overall median survival of the patients treated with a combination of these drugs is 33.6 months when compared to the survival period of 16.9 months in patients treated with vemurafenib monotherapy. It is a secondary end point, which is not included in the published results.
According to Dr. Keith T. Flaherty, it is a great achievement in prolonging the survival rate of patients suffering from advanced BRAF-mutant metastatic melanoma using a combination of binimetinib and encorafenib. It is a promising therapy for the patients in the oncology.
The toleration levels of these drugs are also great in patients with advanced BRAF-mutant metastatic melanoma. The median duration to treat patients using binimetinib is 50.6 months whereas for the treatment using encorafenib is 51.2 weeks. Only mild side effects like hypertension (6%), creatine phosphokinase (7%), and gamma-glutamyltransferase (9%) are observed in more than 5% of the treated patients.
The US FDA is currently reviewing the effectiveness of the treatment provided using a combination of binimetinib and encorafenib to the patients with BRAF-mutant metastatic melanoma in advanced stages. The target action date for both the drugs is set on June 30, 3018. The marketing authorization applications for both of the drugs is under active review by Australian Therapeutic Goods Administration, the Swiss Medicines Agency, and the European Medicines Agency.
The new drugs will provide a promising therapy for the life threatening skin cancer (Metastatic melanoma) that is related to lower survival rates. Annually around 200,000 new cases of Metastatic melanoma is reported worldwide.