Results from Bristol-Myers Squibb Company’s phase 2 clinical trial CheckMate -063 studying Opdivo (nivolumab) in patients with advanced squamous cell non-small cell lung cancer (NSCLC) indicated a 15% objective response rate for treated patients. Full data will be discussed at the 2014 Chicago Multidisciplinary Symposium of Thoracic Oncology held today.
“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,” said Suresh S. Ramalingam, MD, Professor and Director of Medical Oncology at Winship Cancer Institute of Emory University, in a news release from Bristol-Myers Squibb. “The results are also consistent with Phase 1 data previously reported from Study -003.”
Impressively, patients treated during the trial had an average estimated one-year survival rate of 41%–the historic rate for third-line squamous cell NSCLC is less than 18%. Median overall survival was 8.2 months.
“Results from CheckMate -063 offer further clinical evidence of the potential of immuno-oncology as an innovative approach to treating this disease,” said Michael Giordano, senior vice president and Head of Development in the Oncology Department. “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.”
The immuno-oncology agent Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor. It binds to the checkpoint receptor PD-1 on activated T-cells, allowing them to attack tumor cells trying to evade detection. Bristol-Myers Squibb is interested in using Opdivo against multiple tumor types in more than 35 clinical trials, either as a stand-alone monotherapy, such as that used in CheckMate -063, or as a combination therapy. So far, more than 7,000 patients have been enrolled in these trials.
CheckMate -063 was initiated to evaluate the overall response rate of advanced squamous cell NSCLC patients who saw improvements following both platinum-based therapy and one additional systemic therapy. Overall survival and adverse events were also assessed.
Opdivo was granted Fast Track designation by the US Food and Drug Administration. Designation will enable more rapid approval for marketing and patient treatment, should clinical trials continue to show promising results.