Bristol-Myers Squibb, Ono Report Survival Benefit For Opdivo In Melanoma
By Cyndi Root
Bristol-Myers Squibb (BMS) and its partner on Opdivo (nivolumab), Ono Pharmaceuticals, report that the immunotherapy boosted overall survival in patients with melanoma. The companies announced the findings in a press release, stating that results from the CheckMate-066 trial were presented at the Society for Melanoma Research 2014 International Congress in Zurich, Switzerland. Prof. Caroline Robert of the Institute Gustave Roussy and lead investigator, said, “The results from CheckMate -066 are significant as they represent the first time a PD-1 immune checkpoint inhibitor has shown a survival benefit in a randomized Phase 3 trial.”
Opdivo (nivolumab) is a PD-1 immune checkpoint inhibitor, Food and Drug Administration (FDA) fast-tracked for Renal Cell Carcinoma (RCC), non-small cell lung cancer (NSCLC), and melanoma. The FDA also gave the agent Breakthrough Therapy designation for Hodgkin lymphoma. BMS and Ono have partnered to develop Opdivo and other immunotherapies. BMS is conducting over 50 trials of Opdivo worldwide on several different types of cancer.
Opdivo in Melanoma
BMS and Ono reported the findings in the CheckMate-066 trial of Opdivo in 418 treatment-naïve patients with wild-type BRAF advanced melanoma. The Phase 3 trial compared Opdivo to dacarbazine (DTIC), a chemotherapy treatment. The results showed that Opdivo conferred a survival benefit, meeting the primary endpoint. At one year, Opdivo patients had a 73 percent overall survival rate (OS) vs. 42 percent in the DTIC group. This benefit was true for PD-L1 positive and PD-L1 negative patients. The objective response rate was higher with Opdivo than DTI — 40 percent vs. 14 percent. Investigators also noted fewer adverse events in Opdivo patients.
Opdivo in Lung Cancer
Recently, BMS and Ono reported that Opdivo did well in a Phase 2 trial for lung cancer, the CheckMate -063 trial. Based on the results, BMS stated that it initiated a rolling New Drug Application (NDA) with the FDA for the agent in NSCLC. The trial showed an independent review committee (IRC) that Opdivo allowed patients a one-year survival rate of 41 percent, which is significant due to the usual 5 to 18 percent one-year survival of most NSCLC patients.