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First-line treatment with serplulimab plus chemotherapy improves survival over chemotherapy alone in patients with advanced squamous non-small cell lung cancer (NSCLC), according to a study presented at the 2023 World Conference on Lung Cancer.
Serplulimab prolonged both progression-free survival (PFS) and overall survival (OS), said study presenter Caicun Zhou, MD, PhD, of Shanghai Pulmonary Hospital in China.
Dr Zhou presented these updated results from the phase 3 ASTRUM-004 study, which included 537 patients with stage IIIB/C or IV squamous NSCLC who had not received prior systemic therapy.
The patients were randomly assigned to receive serplulimab (n=358) or placebo (n=179), each in combination with carboplatin and nab-paclitaxel for 4-6 cycles. Patients then received serplulimab or placebo maintenance. Serplulimab could be given for up to 2 years, and patients in the placebo arm could cross over to the serplulimab arm after progression.
Baseline characteristics were well balanced between the arms. The median age was 63 years in both arms (overall range, 35-86). In both arms, roughly 90% of patients were men, about 67% were Asian, and nearly 30% had stage IIIB/C disease. The median follow-up was 31.1 months.
The median PFS was 8.3 months in the serplulimab arm and 5.7 months in the chemotherapy-alone arm (hazard ratio [HR], 0.55; 95% CI, 0.43-0.69; P <.001).
The median OS was 22.7 months in the serplulimab arm and 18.2 months in the chemotherapy-alone arm (HR, 0.73; 95% CI, 0.58-0.93; P =.010).
The objective response rate was 60.1% in the serplulimab arm and 40.8% in the chemotherapy-alone arm. The median duration of response was 11.1 months and 5.5 months, respectively (HR, 0.45; 95% CI, 0.32-0.65).
Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 35.5% of patients in the serplulimab arm and 31.8% of those in the chemotherapy-alone arm. The rate of serious TRAEs was 33.2% and 27.4%, respectively. The rate of fatal TRAEs was 1.1% in both arms.
Based on these results, Dr Zhou concluded that serplulimab plus chemotherapy represents a new treatment option for advanced squamous NSCLC.
Disclosures: This research was supported by Shanghai Henlius Biotech, Inc. Study authors’ disclosures were not provided, but 7 authors are employed by Shanghai Henlius Biotech, Inc.
Reference
Zhou C, Hu Y, Arkania E, et al. A phase 3 study of serplulimab plus chemotherapy as first-line treatment for squamous non-small-cell lung cancer (ASTRUM-004). Presented at WCLC 2023. September 9-12, 2023. Abstract OA09.05.
This article originally appeared on Cancer Therapy Advisor
