Does adding an immune checkpoint inhibitor to cytokine-induced killer (CIK) cells improve the efficacy of chemotherapy for patients with non-small cell lung cancer (NSCLC)? What are the adverse reactions to this combination therapy? However, these issues are not obvious. To assess the safety and efficacy of autologous CIK cell therapy in combination with Sintilimab, an antibody against programmed cell death-1, and chemotherapy in previously untreated patients with advanced NSCLC, researchers undertook a phase 1b trial. Maintenance treatment with Sintilimab in squamous and with Sintilimab plus pemetrexed in non-squamous NSCLC until disease progression or intolerable toxicity, or 2 years, was administered to patients with stage IIIB/IIIC/IV NSCLC every 3 weeks for 4 cycles. The objective response rate (ORR) and the number of adverse events were considered primary endpoints.
About 34 patients were treated in total. About 94.1% of people receiving therapy had treatment-related adverse events (TRAEs). About 64% of patients experienced TRAEs of grade 3 or above. A grade 5 immune-related pneumonia caused the death of 1 patient (2.9%). DCR was 100% (95% CI: 89.7%-100.0%), and ORR was 82.4% (95% CI: 65.5%-93.2%). Treatment efficacy was measured objectively in 14 of 15 non-squamous patients (93.3 percent; 95% CI, 68.1% to 99.8%) and 14 of 19 squamous patients (73.7%; 95% CI, 48.8% to 90%). The median PFS was 19.3 months (95% CI, 8.3 months not available).
Non-small cell lung cancer (NSCLC) patients who had not received any prior treatment found that autologous CIK cells immunotherapy in combination with Sintilimab plus chemotherapy was well tolerated and showed good results.