Combining first-line tislelizumab (Tevimbra) with platinum-etoposide chemotherapy demonstrated encouraging efficacy with an acceptable safety profile in patients with extensive-stage small cell lung cancer (ES-SCLC), according to a multicenter, real-world retrospective analysis presented at the IASLC 2026 World Conference on Lung Cancer (WCLC).¹
What were the efficacy outcomes in the overall population?
At a median follow-up of 6.3 months, the 124 patients treated with first-line tislelizumab plus platinum-etoposide chemotherapy achieved a median progression-free survival (PFS) of 7.2 months and a median overall survival (OS) of 19.3 months. The investigators concluded that the regimen provided encouraging efficacy in a real-world ES-SCLC population, most of whom had stage IV disease. Among the cohort, 91.9% had stage IV disease at presentation, 27.4% had brain metastases, and 18.5% had liver metastases.
What did the radiotherapy subgroup analysis show?
Among the 41 patients who received thoracic radiotherapy added to tislelizumab and chemotherapy, the median PFS was 16.2 months vs 7.2 months in the overall population (hazard ratio HR, 0.50; 95% CI, 0.32-0.78), and the median OS was 25.1 months (HR, 0.57; 95% CI, 0.23-1.40).
“This multicenter real-world study suggests that first-line tislelizumab combined with platinum-etoposide chemotherapy provides encouraging efficacy with an acceptable safety profile in patients with ES-SCLC,” G. Jin, of Second Hospital of Shanxi Medical University, Taiyuan/CN, wrote with coauthors in the poster.1 “Furthermore, the addition of radiotherapy was associated with prolonged [PFS], indicating a potential survival benefit that warrants further prospective investigation.
What was the safety profile of tislelizumab plus chemotherapy?
Treatment-related adverse events (TRAEs) occurred in 30 of 124 patients (24.2%), with 33 events reported overall. The most common TRAEs were gastrointestinal (GI) reactions (8.1%) and bone marrow suppression (7.3%), followed by pneumonitis (4.8%) and pneumonia (1.6%). Grade 3 or higher TRAEs occurred in 2 patients (1.6%), all of which were GI reactions. Immune-related events, including 1 case each of hypophysitis and myocarditis, were uncommon.
What was the study design and context?
According to the study investigators, immune checkpoint inhibitors plus platinum-etoposide chemotherapy is the standard frontline regimen for patients with ES-SCLC, although real-world evidence for tislelizumab in combination with chemotherapy was limited in this setting. The multicenter, retrospective study was designed to evaluate the efficacy and safety of first-line tislelizumab plus chemotherapy in patients with histologically or cytologically confirmed ES-SCLC and no prior systemic treatment across tertiary hospitals in China between November 2020 and December 2025.
During the induction phase, patients received tislelizumab at 200 mg on day 1, carboplatin area under the curve 5 or cisplatin at 75 mg/m² on day 1, and etoposide at 100 mg/m² on days 1 to 3 every 3 weeks for 4 to 6 cycles, with optional concurrent thoracic radiotherapy, followed by tislelizumab maintenance at 200 mg every 3 weeks.
The median patient age was 66 years (range, 38-86), 83.9% were male, and 62.9% were current or former smokers. Additionally, 56.5% of patients had an ECOG performance status of 1.
Previously, first-line tislelizumab plus chemotherapy improved long-term survival vs chemotherapy alone in the phase 3 RATIONALE-312 trial (NCT04005716), which supported the combination as a frontline option in ES-SCLC.² Findings presented at the European Society for Medical Oncology Congress 2025 showed a median OS of 15.5 months (95% CI, 13.5-17.1) with tislelizumab plus chemotherapy vs 13.5 months (95% CI, 12.1-14.9) with placebo plus chemotherapy (HR, 0.78; 95% CI, 0.63-0.95).
References
- Jin G, Feng H, Song X, et al. Clinical outcomes of first-line tislelizumab plus chemotherapy in extensive-stage small cell lung cancer: a multicenter real-world analysis. Presented at: 2026 World Conference on Lung Cancer; September 12-15, 2026; Seoul, South Korea. Abstract EP13.08.
- Fan Y, Zhao Y, Huang D, et al. First-line (1L) tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT in extensive-stage small cell lung cancer (ES-SCLC): long-term follow-up (LTFU) of RATIONALE-312. Abstract presented at: European Society for Medical Oncology Congress 2025; October 17-21, 2025; Berlin, Germany. Abstract 2765P.
