Serplulimab Plus Chemotherapy in SCLC

Researchers investigated the effects of adding programmed cell death 1 (PD-1) inhibition to chemotherapy in patients with extensive-stage small cell lung cancer (SCLC). In their interim analysis, published in JAMA, they found that implementing the PD-1 inhibitor, serplulimab, significantly improved overall survival (OS) compared with chemotherapy alone in patients with untreated extensive stage SCLC.

This trail enrolled 585 patients from 114 hospital centers across 6 countries from September 2019 to April 2021. Patients were assigned to receive either 4.5 mg/kg serplulimab (n=389) or placebo (n=196) intravenously every 3 weeks.

In addition, all patients received intravenous carboplatin and etoposide every 3 weeks for up to 12 weeks. The primary end point of the study was OS with a prespecified significance criteria. Secondary outcomes included progression-free survival (PFS) and adverse events (AEs).

Serplulimab Improves Survival in Patients With SCLC

According to the report, 246 (42.1%) of the 585 randomized participants completed the trial through the October 2021 follow-up. The median duration of follow-up was 12.3 months (range, 0.2-24.8). Notably, the authors found that median OS was significantly longer for the serplulimab group at 15.4 months (95% CI, 13.3-not evaluable) compared  with 10.9 months (95% CI, 10.0-14.3) for the placebo group (hazard ratio [HR], 0.49; 95% CI, 5.5-6.9).

Median PFS was also longer in the serplulimab group versus the placebo group at  5.7 months (95% CI, 5.5-6.9) and 4.3 months (95% CI, 4.2-4.5 ), respectively (HR, 0.48; 95% CI, 0.38-0.59). Treatment-related AEs of grade 3 or higher were reported in 129 serplulimab patients (33.2%) and 54 placebo patients (27.6%).

Overall, the authors felt the results of their interim analysis support the use of serplulimab for PD-1 inhibition in patients with extensive-stage SCLC.

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SOURCEJAMA