Neoadjuvant Opdivo plus chemotherapy significantly improves event-free survival.

In a prespecified interim analysis, Opdivo (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. This combination previously showed a significant improvement of pathologic complete response (pCR), the trial’s other primary endpoint. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.

“While the intent of surgery is curative in resectable non-small cell lung cancer, between 30% to 55% of patients experience recurrence after surgery and ultimately succumb to the disease, presenting a strong need for additional options that can disrupt this cycle,” said Nicolas Girard, M.D., Ph.D., professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris. “The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer.”

The company will complete a full evaluation of the available CheckMate -816 data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. Previous results from the CheckMate -816 trial were presented at the 2021 American Association for Cancer Research (pCR data) and 2021 American Society of Clinical Oncology (surgical outcomes) Annual Meetings.

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. The scientific rationale for using immunotherapy in the neoadjuvant setting is twofold: the presence of a tumor during immunotherapy treatment may enable a stronger immune response, potentially making the treatment more effective against a primary tumor, while offering an opportunity to target covert micro-metastasis. 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.