4-year update from CheckMate 816

In the pivotal, phase III CheckMate 816 study, neoadjuvant nivolumab in combination with chemotherapy was shown to significantly improve the pathological complete response rate (pCR) and event-free survival (EFS) in patients with resectable, non-small cell lung cancer (NSCLC). At ASCO 2024, 4-year follow-up data of this trial were presented. We asked Dr Nicolas Girard, medical oncologist at the Curie Institute in Paris, France, and co-investigator of CheckMate 816 to talk us through these updated results.

CheckMate 816 randomly assigned 358 patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. In this 4-year follow-up, the median EFS with neoadjuvant nivolumab + chemotherapy was reported at 43.8 months as compared to 18.4 months with chemotherapy alone (HR[95%CI]: 0.66[0.49-0.90]). At the 4-year landmark, 49% of patients in the nivolumab + chemotherapy arm were event free as compared to 38% with chemotherapy alone.

Also in terms of overall survival (OS) (HR[95%CI]: 0.71[0.47-1.07]) the addition of nivolumab to neoadjuvant chemotherapy proved to be beneficial, although this benefit did not yet reach the boundary for statistical significance.

For Dr Girard, these updated findings further support the use of neoadjuvant nivolumab plus chemotherapy in patients with resectable NSCLC. Interestingly, the Kaplan-Meier curve for EFS in patients treated with neoadjuvant nivolumab and chemotherapy appears to plateau at about 50% from year 4 onwards. For the years to come, one of the main research questions consists of the identification of patients who will obtain a long-term benefit with neoadjuvant chemo-immunotherapy and surgery alone and distinguish them from the ones who require further adjuvant therapy.