386P A single-arm phase Ib study of autologous cytokine-induced killer (CIK) cell immunotherapy in combination with sintilimab plus chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)

Abstract

Immune checkpoint inhibitors plus chemotherapy has demonstrated significant survival benefits for advanced non-small-cell lung cancer (NSCLC) patients without targetable mutations. Autologous cytokine-induced killer (CIK) cell therapy can restore the antitumor immunity to improve the patient outcomes. Therefore, a single-center, open-label, phase Ib trial was conducted to explore the efficacy and safety of autologous CIK cell therapy combined with sintilimab (anti-PD-1) plus chemotherapy as 1L treatment in advanced NSCLC patients (NCT03987867). Systemic therapy naïve patients with stage IIIB-IV NSCLC would receive platinum-based doublet chemotherapy, sintilimab (200mg, d1), and intravenous autologous CIK cells (1010, d14) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoints were safetyand the objective response rate (ORR) assessed per RECIST v1.1.Secondary endpoints were progression-free survival (PFS) and overall survival (OS). From May 2019 to Jun 2020, 16 pts aged 46-72 years (median age 62 years) were enrolled. The squamous/non-squamous ratio was 44%/56%. 14 (87.5%) were men, 15(93.7%) were ECOG PS=0-1, 3 (18.75%) had liver metastases, and 2 (12.5%) had brain metastases. Among 13 evaluable pts, the ORR and DCR were 84.6% and 100%, respectively. Among the 11 PR assessed by RECIST, CR was demonstrated in 3 (23.1%) by PET-CT. At the time of data cutoff, the median DOR was not reached (range 2.43m-NA), and the median PFS and OS were not mature (median follow-up time 5.65m, range 0.63-13.3).Adverse events (AEs) occurred in 15 (93.75%), including 4 Grade≥3 AEs events (25%). The most common AEs were nausea (12, 75%), anemia (11, 68.75%), and leukopenia (10, 62.5%).Immune-related AEs were cardiomyopathy (1, 6.25%) and pneumonia (3, 18.75%),1 pts had immune-related grade 5 pneumonia. Autologous CIK cell therapy in combination with sintilimab plus chemotherapy were well tolerated and showed encouraging efficacy. Further studies are warranted to confirm these preliminary results.