Bristol-Myers Squibb announced that its Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.
CheckMate-066 is a double-blind study of patients with previously untreated BRAF wild-type unresectable Stage III and IV melanoma that randomized 418 patients to receive either nivolumab 3mg/kg every two weeks or DTIC 1000mg/m2every three weeks. The primary endpoint was overall survival.
Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. BMS is investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.
The global development program for nivolumab includes trials in non-small cell lung cancer melanoma (NSCLC), renal cell carcinoma (RCC), head and neck cancer, glioblastoma, and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for nivolumab in NSCLC, melanoma and RCC. In May 2014, the FDA granted nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.
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