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)

Background

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).

Methods

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).

Results

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.

Conclusions

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.

Clinical trial identification

NCT03987867.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

The National Key Technologies R&D Program of China grant Awards No. 2018YFC1313400 (to Jianchuan Xia).

Disclosure

All authors have declared no conflicts of interest.