1. CheckMate-816 Study
CheckMate-816 is a randomized, open-label, multicenter Phase III clinical study evaluating neoadjuvant nivolumab (O drug) plus chemotherapy (3 cycles) versus chemotherapy alone Efficacy and safety of chemotherapy (3 cycles) in patients with resectable stage Ib-IIIa NSCLC. The primary endpoints of the study: pathological complete response (pCR) and event-free survival (EFS).
①O drug + chemotherapy group vs chemotherapy group: pCR were 24% vs 2.2%;
②O drug + chemotherapy group vs chemotherapy group: EFS were 31.6 months vs 2 0.8 months;
. The NADIM study
The NADIM study is an open-label, multicenter, single-arm, Phase II clinical study. Stage IIIa NSCLC patients who meet the inclusion criteria receive nivolumab (fixed dose 360 mg) combined with paclitaxel ( 200mg/m2) and carboplatin (AUC=5) treatment, the treatment is a cycle of 21 days, and the drug is administered on the first day of each cycle. After receiving three cycles of treatment, surgery will be performed within 42 to 49 days after the end of the last cycle of treatment. The primary endpoint of the study is pCR, and the secondary endpoints are: major pathological response rate (MPR), 3-year OS, PFS, and ctDNA analysis .
①O drug + chemotherapy group vs chemotherapy group: pCR was 36.8% vs 6.9%;
②O drug + chemotherapy group vs chemotherapy group: MPR was 52.6% vs 13.8%;
③New adjuvant chemotherapy +nivolumab Treatable with surgery The efficacy in NSCLC was supported by 3-year OS. ctDNA levels were significantly associated with OS and were better than imaging assessment in predicting survival.
④ Tumor mutation burden (TMB) and PD-L1 levels cannot predict prognosis. Low levels of ctDNA before treatment were significantly associated with improved PFS and OS. In multivariate analysis, PFS and OS were significantly improved in patients with high baseline ctDNA levels and those with low baseline levels (1% MAF).
