Nivolumab melanoma trial stopped early on efficacy

Bristol-Myers Squibb Co. (NYSE:BMY) said the Phase III CheckMate -066 trial was stopped early after an independent DMC said IV nivolumab ( BMS-936558) every two weeks met the primary endpoint of improving overall survival (OS) vs. dacarbazine as first-line treatment of melanoma. The double-blind, placebo-controlled, international trial enrolled 418 patients with unresectable wild-type BRAF stage III or stage IV melanoma. BMS said it will share the data will regulatory authorities, but declined to comment on plans for regulatory submissions for the human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279). CheckMate -066 was designed in consultation with EMA's CHMP.

Earlier this year, BMS started submission of a rolling BLA to FDA for nivolumab as third-line treatment of squamous non-small cell lung cancer (NSCLC). The pharma expects to complete the application by year end. Phase III trials in melanoma, NSCLC and renal cell carcinoma (RCC) are ongoing. BMS has worldwide rights to nivolumab from Ono Pharmaceutical Co. Ltd. (Tokyo:4528), excluding Japan, Korea and Taiwan, where Ono retains rights. Ono submitted an NDA in Japan for nivolumab to treat malignant melanoma in December. ...