Nicolas Girard, MD, on the rationale and design of the CheckMate 816 Phase 3 trial in resectable NSCLC


In an interview with CancerNetwork®, Nicolas Girard, MD, discussed the rationale for evaluating nivolumab and chemotherapy in resectable non-small cell lung cancer and the design of the Phase 3 CheckMate 816 trial. .

In an interview with CancerNetwork® during the American Association for Cancer Research (AACR) 2022 Annual MeetingNicolas Girard, MD, Professor of Respiratory Medicine at Versailles Saint Quentin University and Director of Institut Curie-Montsouris Thorax at Institut Curie in Paris, emphasized the rationale for evaluating nivolumab (Opdivo) and chemotherapy in resectable non-small cell lung cancer.

In addition to highlighting previous results with the combination, he detailed the design of the Phase 3 CheckMate 816 trial (NCT02998528), which evaluated the regimen versus chemotherapy alone in the aforementioned patient population.

Transcription:

We have numerous phase 2 studies that have demonstrated the benefit of neoadjuvant immunotherapy with immune checkpoint inhibitors targeting PD-1 or PD-L1, particularly in terms of pathological response. [As these were] only phase 2 studies, it has always been difficult to know if this is a real benefit compared to the reference treatment, which historically has been chemotherapy. In this study, Checkmate 816, we randomized 358 patients to receive a combination of nivolumab plus chemotherapy vs chemotherapy alone.

[The trial had] 2 main parameters [including] pathological complete response and event-free survival. The advantage of the neoadjuvant approach is to include all patients eligible for surgical resection of the tumour. With this, we treated patients for 3 cycles before surgery, and then surgery was performed in the majority of patients – 83.2% in the experiment [arm] and 75.4% in control [arm].

Reference

Forde PM, Spicer J, Lu S, et al. CheckMate Investigators 816. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N English J med. Published online April 11, 2022. doi:10.1056/NEJMoa2202170

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