Journal: Signal transduction and targeted therapy
The CA209-7AL phase 2 trial evaluated the efficacy and safety of consolidative nivolumab (NIVO) versus observation after neoadjuvant NIVO plus chemotherapy and concurrent chemoradiotherapy (CCRT) in unresectable stage III NSCLC.
Among 172 randomized patients, consolidative NIVO significantly improved progression-free survival (PFS) compared to observation (median not reached vs. 12.2 months; HR 0.49, p=0.003) after a median follow-up of 22.8 months.
Toxicities grade 3-4 were slightly higher with NIVO consolidation (9.3% vs. 4.6%), with similar rates of pneumonitis and bronchial toxicity. One treatment-related death from pneumonitis occurred.
Patients with high tumor mutational burden (TMB) derived greater PFS benefit.
Overall, consolidative NIVO post-neoadjuvant therapy and CCRT was effective and well-tolerated in this patient population.