Roche (RHHBY) announced that its phase III study, coBRIM, on pipeline candidate, cobimetinib, achieved its primary endpoint.
The data from the study showed that MEK inhibitor cobimetinib used in combination with Roche’s BRAF inhibitor Zelboraf was effective in treating patients with previously untreated BRAF V600 mutation-positive advanced melanoma. The combination helped patients to live significantly longer without their disease worsening as compared to Zelboraf alone.
Consequently, the study met its primary endpoint of progression free survival.
Roche expects to present data from the study at an upcoming medical meeting. Roche also expects to submit the data from the study to the FDA for a potential approval in the U.S.
Roche is developing cobimetinib in collaboration with Exelixis Inc. (EXEL). We remind investors that Zelboraf, a BRAFV600-targeted therapy, is approved for the treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma in more than 80 countries. The drug was launched in 2011.
Sales from Zelboraf came in at CHF 79 million in the first quarter of 2014, down 2% due to competition in the U.S.
The successful development and commercialization of cobimetinib will further boost Roche’s skin cancer franchise.
We note that cobimetinib is also being developed in combination with other candidates as an immunotherapy, in several tumor types, including non-small cell lung cancer and colorectal cancer.
Roche, a large cap pharma, currently carries a Zacks Rank #3 (hold). Some better-ranked large cap pharmas in the industry include AbbVie, Inc. (ABBV) and Johnson & Johnson (JNJ). Both the stocks carry a Zacks Rank #2 (Buy).