Nivo-adjuvant.

Top Line: Does the addition of immunotherapy to neoadjuvant chemotherapy improve response rate for resectable NSCLC?

The Study: A meta-analysis has shown that neoadjuvant systemic therapy improves overall survival by 5% at 5 years in patients with resectable, stage IB-IIIA NSCLC. Immunotherapy already plays an important role in the treatment of unresectable and metastatic NSCLC, and it has been making its way through early phase trials in the neoadjuvant setting for resectable disease. We finally have the full manuscript for CheckMate 816, where 352 patients with stage IB-IIIA NSCLC were randomized and received 3 cycles of neoadjuvant platinum-doublet chemotherapy with or without nivolumab. Patients were allowed to receive additional adjuvant chemotherapy and/or radiation, but no additional immunotherapy. Most (64%) had stage IIIA disease, and most (50%) had PD-L1 ≥1%. Slightly more patients in the immunochemotherapy arm went on to have surgery (83% v 76%) and an R0 resection (83% v 78%). Immunochemotherapy significantly prolonged the primary outcome of event free survival (EFS) from 21 → 32 months. The rate of EFS at 2 years was 64% v 45%. Subgroups with stage IIIA disease (vs stage I-II), PD-L1 ≥1%, and non-squamous histology appeared to derive greater benefit from the addition of immunotherapy. The addition of immunotherapy also significantly increased the pathologic complete response (pCR) rate from 2 → 24%. Patients who had pCR had better EFS than those who didn’t, and the latter group did not appear to derive an EFS benefit from the addition of immunotherapy.

TBL: The addition of nivolumab to neoadjuvant platinum doublet chemotherapy significantly improves event free survival for patients with resectable stage IB-IIIA NSCLC, primarily among those with non-squamous histology. | Forde, N Engl J Med 2022