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AACR 2022: Nivolumab Plus Chemotherapy for Resectable Lung Cancer in Phase III CheckMate 816 Trial

By: Joseph Fanelli
Posted: Monday, April 25, 2022

According to findings presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT012), patients with resectable non–small cell lung cancer (NSCLC) had a statistically significant and clinically meaningful improvement in event-free survival when treated with neoadjuvant nivolumab plus chemotherapy, compared with those treated with chemotherapy alone. The results of the phase III CheckMate 816 trial showed that  for patients with stage IB to IIIA resectable NSCLC, the combination regimen reduced the risk of disease recurrence, progression, or death by 37%. Nicolas Girard, MD, PhD, of the Institut du Thorax Curie-Montsouris, Paris, and colleagues also simultaneously published their findings in The New England Journal of Medicine. At 2 years, 83% of patients treated with the combination regimen were alive, compared with 71% given chemotherapy alone; upcoming study analyses will follow overall survival.

In the randomized CheckMate 816 study, the authors enrolled adults with stage IB to IIIA resectable NSCLC, an Eastern Cooperative Oncology Group performance status of at least 1, and no known EGFR/ALK alterations. Patients received either 360 mg of nivolumab plus chemotherapy (n = 179) or chemotherapy alone (n = 179).

After a median follow-up of 29.5 months, adding neoadjuvant nivolumab to chemotherapy significantly improved event-free survival in patients (31.6 months), compared with those who received chemotherapy alone (20.8 months). In the pooled patient population—with both groups combined—event-free survival was improved in patients with a pathologic complete response (median time not reached) versus patients without a pathologic complete response (21.1 months).

In regard to grade 3 or 4 treatment- and surgery-related adverse events, both treatment options yielded similar toxicity. Among patients receiving nivolumab plus chemotherapy, 33.5% reported treatment-related events, and 11.4% had surgery-related events, whereas 36.9% and 14.8% of patients treated with chemotherapy alone had treatment- and surgery-related events, respectively.

Disclosure: For a full disclosure of the study authors, visit abstractsonline.com.


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