Bristol Myers announces positive results from phase 3 CheckMate -816 trial of neoadjuvant nivolumab in combo with chemotherapy to treat resectable NSCLC

Bristol Myers Squibb announced results from the phase 3 CheckMate -816 trial, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) in combination with chemotherapy significantly improved event-free survival (EFS), a primary endpoint, compared to chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC). With a minimum follow-up of 21.0 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 37% (Hazard Ratio [HR] 0.63; 97.38% Confidence Interval [CI]: 0.43 to 0.91; p=0.0052) across randomized patients when administered before surgery. In patients receiving the combination, median EFS was 31.6 months, compared to 20.8 months for patients treated with chemotherapy alone. Additionally, while the data are still immature and the analysis did not reach statistical significance, favourable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy (HR 0.57; 99.67% CI: 0.30 to 1.07). At two years, 83% of patients treated with neoadjuvant Opdivo and chemotherapy were alive, compared to 71% with chemotherapy alone. OS will continue to be followed for upcoming analyses. CheckMate -816 represents the first phase 3 study with an immunotherapy-based combination to show a significant improvement in EFS, as well as in the other primary endpoint of pathologic complete response (pCR), in the neoadjuvant setting of NSCLC. The EFS data presented for the first time during the Neoadjuvant and Perioperative Immunotherapy Clinical Trials Plenary Session (Abstract #CT012) at the American Association for Cancer Research (AACR) Annual Meeting 2022 on Monday, April 11, 2022.

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