Dr. Moghanaki on Remaining Questions Following the CheckMate-816 Trial in NSCLC

Drew Moghanaki, MD, MPH, the Stanley Iezman and Nancy Stark Endowed chair, Thoracic Radiation Oncology Research, professor, chief of Thoracic Oncology, Department of Radiation Oncology, the University of California, Los Angeles (UCA), discusses questions that still need to be addressed following the phase 3 CheckMate-816 trial (NCT02998528) of the neoadjuvant combination nivolumab (Opdivo) plus chemotherapy in patients with non–small cell lung cancer (NSCLC).

In March 2022, the FDA approved nivolumab plus platinum-doublet chemotherapy for adult patients with resectable NSCLC in the neoadjuvant setting, based on findings from CheckMate-816.

Data from the trial showed that patients treated with the combination (n = 179) experienced a median event-free survival of 31.6 months (95% CI, 30.2–not reached), compared with 20.8 months (95% CI, 14.0-26.7) with patients given chemotherapy alone (n = 179; HR, 0.63; 95% CI, 0.45-0.87; P =.0052). Additionally, nivolumab plus chemotherapy elicited a pathologic complete response (pCR) rate of 24% (95% CI, 18.0%-31.0%) vs 2.2% (95% CI, 0.6%-5.6%) with chemotherapy alone.

The trial included patients with newly diagnosed, resectable, stage IB to IIIA NSCLC who had an ECOG performance status of 0 or 1 and no known sensitizing EGFR mutations or ALK alterations.

Despite the benefits observed with the combination during the trial, the study did not address whether patients who are eligible to receive either pre-operative chemotherapy or chemoimmunotherapy checkpoint inhibitors should be treated with a chemoradiation approach instead, Moghanaki says.

Although outcomes can be good for patients who achieve a pCR, investigators next need to learn how to identify those patients who are not going to respond well to chemoimmunotherapy, according to Moghanaki. Clinicians must also identify patients with residual disease in order to know when to further escalate treatment to keep increasing the cure rate for this population, Moghanaki concludes.