Abstract 308P
Background
Integrating serplulimab (an anti-PD-1 mAb) into first-line etoposide plus carboplatin/cisplatin (EP) regimens has demonstrated significant benefits in extensive-stage small cell lung cancer (ES-SCLC). This study aims to evaluate the real-world outcomes of serplulimab combined with chemotherapy in ES-SCLC.
Methods
This nationwide observational study was conducted in China and included patients with pathologically confirmed ES-SCLC who received serplulimab as first-line treatment (NCT06748495). All patients were managed according to current clinical guidelines and followed until death or loss to follow-up. Real-world progression-free survival (rwPFS), overall survival (OS), tumor response, and adverse events (AEs) were assessed to evaluate the real-world outcomes.
Results
Clinical data from 635 patients were analyzed, with a median follow-up of 14.9 months. Among the patients, 543 (85.5%) were male, 441 (69.4%) were smokers, and the median age was 63 years. Among 630 patients with measurable disease, 7 achieved complete response, and 428 achieved partial response, representing an overall response rate (ORR) of 69.0% (95% CI, 65.3–72.6). The median rwPFS was 8.2 months (95% CI, 7.4–9.2), with a 1-year rwPFS rate of 31.5%. Patients with brain metastases had a numerically lower median rwPFS than those without brain metastases (7.4 vs. 8.3 months, log-rank p=0.431). Patients with liver metastases had a worse median rwPFS compared to those without liver metastases (6.4 vs. 9.3 months, log-rank p < 0.001). The median OS for all patients was 17.2 months (95% CI, 15.4–19.8), with a 2-year OS rate of 39.2%. AEs were reported in 233 patients (36.7%), with 81 patients (12.8%) experiencing grade ≥3 AEs. Treatment interruptions due to AEs were documented in 78 patients (12.3%), and 3 patients (0.5%) reported AE-related deaths. Serplulimab-related AEs were observed in 20.5% of patients, predominantly grade 1–2 (16.7%), with no new safety signals.
Conclusions
This large-scale, nationwide observational study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC. The results support its application in broader patient populations for this setting.
Legal entity responsible for the study
L. Wu.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.