The phase III CheckMate-816 trial met a primary endpoint of pathologic complete response in resectable non-small cell lung cancer.
In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate-816 is the first and only phase III trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.
Opdivo is sponsored by Bristol Myers Squibb.
Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.
“Nivolumab has shown benefit as an adjuvant, or post-surgical, treatment option in other cancer types, and the positive results from CheckMate -816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer,” Mark Awad, clinical director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a statement.
The CheckMate-816 trial is ongoing to assess the other primary endpoint of event-free survival, to which the company remains blinded, as well as key secondary endpoints.
In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. To date, Opdivo has shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
