Bristol-Myers Squibb's Opdivo Succeeds Again In Lung Cancer Phase 2 Trial
By Cyndi Root
Bristol-Myers Squibb (BMS) has succeeded again in the CheckMate -063 Phase 2 trial testing Opdivo (nivolumab) against advanced squamous cell non-small cell lung cancer (NSCLC). The PD-1 immune checkpoint inhibitor was consistent with Phase 1 data from Study-003. BMS announced the results in a press release, stating that it initiated a rolling New Drug Application (NDA) with the Food and Drug Administration (FDA) and expects to complete the submission by the end of the year. The company is proceeding with its partner, Ono Pharmaceutical, to characterize the agent in multiple trials, pursue regulatory approvals, and proceed with manufacturing and marketing. Michael Giordano, Head of Oncology Development at BMS, said, “Results from CheckMate -063 offer further clinical evidence of the potential of immuno-oncology as an innovative approach to treating this disease.”
Opdivo
Opdivo (nivolumab) is a fully-human PD-1 immune checkpoint inhibitor that BMS is investigating for multiple cancer types, as a single treatment or in combinations. The FDA fast-tracked the agent for NSCLC, melanoma, and Renal Cell Carcinoma: (RCC) and gave it Breakthrough Designation for Hodgkin lymphoma. In Japan, Ono was able to secure the agent’s first approval for patients with unresectable melanoma. BMS and Ono refined their agreement in July 2014, and the two companies announced that they intended to jointly develop and commercialize multiple immunotherapies, including Opdivo.
CheckMate -063 Opdivo Study
An independent review committee (IRC) evaluated the results from the Phase 2 CheckMate study and found that the estimated one-year survival rate was 41 percent and the median overall survival (mOS) was 8.2 months. Patients with this type of NSCLC typically have one-year survival rates of 5.5 to 18 percent. BMS is presenting the data in Chicago at the Multidisciplinary Symposium on Thoracic Oncology. Adverse events were similar to previous results. Suresh S. Ramalingam, MD, Professor and Director of Medical Oncology at the Winship Cancer Institute of Emory University, commented, “The Phase 2 findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies.”
Immuno-Oncology
Long-term survival has remained elusive, with standard oncology treatments including surgery, radiation, cytotoxic, or targeted therapies. Quality of life has also been troubling for patients with advanced disease. Immunotherapy shows promise in changing the game, extending life, and improving the way patients live with cancer and cancer treatments.