Abstract 682P
Background
Serplulimab plus chemotherapy was established in the ASTRUM-004 trial to improve survival in patients with unresectable locally advanced or metastatic squamous non-small cell lung cancer (sNSCLC). However, there remains a lack of evidence regarding the efficacy and safety profile of serplulimab in routine clinical practice.
Methods
ASTRUM-004R is a real-world study conducted by Jiangsu Cancer Hospital and 13 other sites in China. Unlike the strict eligibility criteria of the ASTRUM-004 trial, this study accepts more flexible baseline characteristics and chemotherapy choices. The primary endpoints are objective response rate (ORR) and real-world progression-free survival (rwPFS).
Results
A total of 100 patients were eligible for analysis. Among these, 70 patients elected to receive either paclitaxel (n=34) or nab-paclitaxel (n=36) plus platinum and serplulimab as the immunochemotherapy regimen. The median age was 68.0 years, predominantly males (93.0%) and smokers (70.0%). The majority had an ECOG performance status of 0 or 1 (80.0%), and 37% presented with comorbidities. Additionally, 42.0% of patients received induction therapy for >4 cycles, and 11.0% had undergone radiotherapy. The ORR was 64.0% (95% CI 53.8-73.4), and the DCR was 96.0% (95% CI 90.1-98.9). Although numerically higher ORR was observed in patients treated with nab-paclitaxel (75.0%) compared to paclitaxel (55.9%), this difference was not statistically significant. Moreover, both treatments showed comparable DCRs (100% for paclitaxel vs. 97.2% for nab-paclitaxel). At the time of data cutoff (July 2024), median rwPFS and OS had not been reached, with the 1-year rwPFS rate estimated by the Kaplan-Meier method being 51.6% (95% CI 33.9-78.5). Adverse events of special interest (AESI) were reported in 17.0% of patients.
Conclusions
The results confirmed the efficacy and well-tolerance of serplulimab in squamous NSCLC. In addition, the choice of chemotherapy agents, whether paclitaxel plus platinum, nab-paclitaxel plus platinum, or other combinations, has shown consistent efficacy. These findings support the broader application of serplulimab-based chemotherapy as a first-line treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
B. Shen.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.