Nicolas Girard, MD, on EFS Findings With Nivolumab and Chemotherapy in Resectable NSCLC
Nicolas Girard, MD, highlighted key findings from the CheckMate 816 trial, examining nivolumab and chemotherapy vs chemotherapy alone in resectable non–small cell lung cancer.
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, spoke with CancerNetwork® about key findings from the phase 3 CheckMate 816 trial (NCT02998528) assessing nivolumab and chemotherapy in patients with resectable non–small cell lung cancer.
Treatment with the combination resulted in a median event-free survival (EFS) of 31.6 months compared with 20.8 months in the chemotherapy-alone cohort (HR, 0.63; 97.38% CI, 0.43-0.91; P = .005). Additionally, the pathologic complete response (pCR) rate was 24.0% vs 2.2% in the 2 arms, respectively.1
Transcript:
During this meeting, I presented the EFS and the OS [findings]. What we see is that after a median follow up of 21 months, we had a benefit in terms of EFS with the combination of nivolumab plus chemotherapy. Median EFS was 31.6 months in the experimental arm vs 20.8 months with chemotherapy alone. This is an improvement by almost 1 year.
This translates into a trend for an overall survival benefit [that needs to be confirmed] and we have a hazard ratio of 0.57 [99.67% CI, 0.30-1.07]. This is likely to become statistically significant with more follow-up. In patients who had a surgical resection of the tumor, [we were able] to show that pathological complete response is a surrogate end point for survival. In the patients who achieved pCR, we have almost a flat curve for disease-free survival. This is very important because achieving PCR is probably a strong predictor of long-term survival in those patients. Benefit with a combination of nivolumab plus chemotherapy was observed in the majority of the subgroups. Even in patients with PD-L1–negative tumors, we had the PCR rate of 17%.This is correlated with EFS. Right now, nivolumab plus chemotherapy is a standard of care for patients with resectable non–small cell lung cancer. This combination has been approved by the FDA in the United States,2 and the results have been published in the New England Journal of Medicine.
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
- U.S. Food and Drug Administration approves Opdivo (nivolumab) with chemotherapy as neoadjuvant treatment for certain adult patients with resectable non-small cell lung cancer. News release. Bristol Myers Squibb. March 4, 2022. Accessed March 4, 2022. https://bit.ly/3INrdQA
These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.
