Nivolumab with chemotherapy improve outcomes in resectable non-small-cell lung cancer: NEJM

A new phase 3 clinical trial revealed that standard treatment with neoadjuvant nivolumab in combination with chemotherapy significantly improved the outcomes for patients with resectable non-small-cell lung cancer (NSCLC). The key findings of this study were published in the recent issue of The New England Journal of Medicine.

This comprehensive study included adults with resectable stage IIA to IIIB NSCLC and randomly assigned participants to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus a placebo. The treatments were administered every three weeks for four cycles. Following surgery, the patients received either adjuvant nivolumab or placebo every four weeks for one year. The primary aim of this study was to evaluate event-free survival based on a blinded independent review.

The interim analysis was conducted at a median follow-up of 25.4 months that demonstrated a substantial improvement in event-free survival for the patients treated with nivolumab. The 18-month event-free survival rate was 70.2% in the nivolumab group when compared to 50.0% in the chemotherapy group. This translated to a hazard ratio for disease progression, recurrence, abandoned surgery or death of 0.58 (97.36% confidence interval [CI], 0.42 to 0.81; P<0.001) that indicated a 42% reduction in the risk of these events for the patients receiving nivolumab.

A pathological complete response was observed in 25.3% of patients in the nivolumab group when compared to just 4.7% in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97). Also, a major pathological response occurred in 35.4% of patients who received nivolumab against the 12.1% in the chemotherapy group (odds ratio, 4.01; 95% CI, 2.48 to 6.49). While treatment-related adverse events of grade 3 or 4 were somewhat higher in the nivolumab group (32.5%) when compared to the chemotherapy group (25.2%), the overall safety profile was consistent with previous studies, with no new safety concerns observed.

These findings illuminate the potential of perioperative treatment with nivolumab to significantly improve the clinical outcomes for patients with resectable NSCLC. The notable improvement in event-free survival, coupled with higher rates of pathological complete and major pathological responses, positions nivolumab as a formidable addition to the current standard of care for lung cancer.

Reference:

Cascone, T., Awad, M. M., Spicer, J. D., He, J., Lu, S., Sepesi, B., Tanaka, F., Taube, J. M., Cornelissen, R., Havel, L., Karaseva, N., Kuzdzal, J., Petruzelka, L. B., Wu, L., Pujol, J.-L., Ito, H., Ciuleanu, T.-E., de Oliveira Muniz Koch, L., Janssens, A., … Provencio Pulla, M. (2024). Perioperative Nivolumab in Resectable Lung Cancer. In New England Journal of Medicine (Vol. 390, Issue 19, pp. 1756–1769). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2311926