In this randomized clinical trial that included 585 patients with extensive-stage Small Cell Lung Cancer, SCLC, who had not previously received systemic therapy, Seplulimab plus chemotherapy, compared with Placebo plus chemotherapy, significantly prolonged survival and decreased the risk for death by 47%.
Seplulimab was already approved in China in March 2022 for different indications.
PD-L1 inhibitors combined with chemotherapy has changed the approach to first-line treatment in patients with extensive-stage Small Cell Lung Cancer, SCLC.
It remained unknown whether adding a PD-1 inhibitor to chemotherapy provided similar or better benefits in patients with extensive-stage SCLC, which would add evidence on the efficacy of checkpoint inhibitors in the treatment of extensive-stage SCLC.
About the Trial
This international, double-blind, phase 3 randomized clinical trial (which is called ASTRUM-005) enrolled patients at 114 hospital sites in 6 countries between September 12, 2019, and April 27, 2021.
Of 894 patients who were screened, 585 with extensive-stage SCLC who had not previously received systemic therapy were randomized to receive either 4.5 mg/kg of סרפלולימאב or Placebo intravenously every 3 weeks.
All patients also received intravenous Carboplatin and Etoposide every 3 weeks for up to 12 weeks.
Results: Small Cell Lung Cancer
The median Survival was significantly longer in the Seplulimab group, 15.4 months than in the Placebo group, 10.9 months
The risk for death was decreased by 47%.
The median time until disease progression also was longer in the Seplulimab group, 5.7 months than in the Placebo group, 4.3 months
Treatment-related side effects that were severe were observed in 129 patients (33.2%) in the Seplulimab group and in 54 patients (27.6%) in the Placebo group.
Conclusions: Small Cell Lung Cancer
Among patients with previously untreated extensive-stage SCLC, Seplulimab plus chemotherapy significantly improved survival compared with chemotherapy alone.
These results support the use of Seplulimab plus chemotherapy as the first-line treatment for this patient population.
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