Nicolas Girard, MD, on the Rationale and Design of the Phase 3 CheckMate 816 Trial in Resectable NSCLC

In an interview with CancerNetwork® during the American Association for Cancer Research (AACR) 2022 Annual Meeting, Nicolas Girard, MD, professor of respiratory medicine at Versailles Saint Quentin University and head of Curie-Montsouris Thorax Institute of Institut Curie in Paris, highlighted the rationale for assessing nivolumab (Opdivo) and chemotherapy in resectable non–small cell lung cancer.

In addition to highlighting previous findings with the combination, he detailed the design of the phase 3 CheckMate 816 trial (NCT02998528), which assessed the regimen vs chemotherapy alone in the aforementioned patient population.

Transcript:

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

[The trial had] 2 primary end points [including] pathological complete response and event-free survival. The advantage of the neoadjuvant approach is to include all the patients eligible for surgical resection of the tumor. With that, we treated the patients for 3 cycles before surgery and then surgery was performed in the majority of patients—83.2% in the experimental [arm] and 75.4% in the control [arm].

Reference

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