Bristol-Myers Squibb Company has announced results from the Phase 2 single-arm CheckMate-063 study, an open-label trial evaluating Opdivo (nivolumab) in patients with advanced squamous cell non-small cell lung cancer (NSCLC). Data will be presented today at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology during the Plenary Session.
Opdivo is an investigational PD-1 immune checkpoint inhibitor given to patients with advanced squamous cell NSCLC who have progressed after a minimum of two prior systemic treatments, and administrated as a single agent.
Patients were followed up for at least 11 months and the observed objective response rate (ORR) was 15 percent (95% CI = 8.7, 22.2); this value was assessed by an independent review committee (IRC) using RECIST 1.1 criteria. The median duration of response rate was not reached. The estimated one-year survival rate was 41 percent (95% CI = 31.6, 49.7) and median overall survival (mOS) was 8.2 months (95% CI = 6.05, 10.91).
Lung cancer kills more than 1.5 million people each year, according the World Health Organization; it is the leading cause of cancer deaths worldwide. These facts alone account for the pertinence of this study and the impact its results present to the scientific community.
Suresh S. Ramalingam, MD, Professor and Director of Medical Oncology, Winship Cancer Institute of Emory University who will present the results noted in a press release: “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 (…) The results are also consistent with Phase 1 data previously reported from Study -003.”
Adverse events (AEs) were reported in 17.1 percent of the patients (grade 3-4 drug-related); the most common were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Twelve percent of patients with multiple comorbidities in the setting of progressive disease stopped treatment due to drug-related events and two patients died.
“Results from CheckMate -063 offer further clinical evidence of the potential of immuno-oncology as an innovative approach to treating this disease (…) We are committed to addressing the significant unmet medical needs of patients with lung cancer and have the broadest development program evaluating our approved and investigational immuno-oncology agents across multiple lines of therapy and histology,” said Michael Giordano, senior vice president, Head of Development, Oncology in a press release.
Bristol-Myers Squibb is evaluating its approved and investigational immunotherapies (as single and combined regimens) within therapy, histology and biomarker expression conducting wires. There are six ongoing Phase 3 trials: four of them are evaluating Opdivo (nivolumab) either in previously treated patients or in chemotherapy-naïve patients; the remaining two trials are evaluating Yervoy combined with chemotherapy in newly diagnosed small cell lung cancer and squamous cell NSCL.