Autologous Cytokine-Induced Killer (CIK) Cell Immunotherapy plus Sintilimab and Chemotherapy in Advanced Non‒Small-Cell Lung Cancer: 3-Year Outcomes From the Phase Ib CCICC-002a Study

We present 3-year results from the CCICC-002a study (ClinicalTrials.gov number: NCT03987867). Autologous CIK cells immunotherapy plus Sintilimab and chemotherapy demonstrated favorable tolerability and encouraging efficacy in previously untreated, advanced NSCLC patients. The CCICC-002a study enrolled 33 patients (34 patients were enrolled at the first analysis, 1 patient was excluded by EGFR mutation in the secondary biopsy). The media follow-up was 40.5 months (range, 38.0 to 43.0 months). By the cut-off date of October 31, 2023, 17 patients had died. Estimated 3-year OS rates was 54.4%; median OS was 37.4 months (95% CI, 27.6–37.4 months). In subgroups, median OS was 27.6 months (95% CI, 13.4–36.5 months) in squamous NSCLC and not reached (95% CI, 29.9 months -not reached) in non-squamous NSCLC, respectively. Estimated 3-year PFS rates were 33.8% and median PFS was 18.1 months (95% CI, 10.1–24.0 months) in all patients; median PFS was 17.0 months (95% CI, 5.0–24.0 months) in squamous NSCLC and 23.5 months (95% CI, 5.7 months -not reached) in non-squamous NSCLC. Median response duration was 19.9 months (95% CI, 10.5–26.2); 24.2% of patients were ongoing at data cut-off; the longest response was ongoing at 51.7 months. Treatment-related AEs (TRAEs) occurred in 97% of patients and resulted in study discontinuation in 6.1%; 66.7% experienced grade 3/4 TRAE. This long-term analysis of CCICC-002a represents the longest follow-up for CIK to date and confirms the durable antitumor activity and tolerability of CIK cells therapy in combination with Sintilimab plus chemotherapy in advanced NSCLC.