WCLC 2025 - Posters & ePosters-EP.13.23 Tislelizumab Plus Sitravatinib or Anlotinib as Maintenance Therapy in Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

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This report presents results from two Phase II clinical trials evaluating maintenance therapy with tislelizumab (a PD-1 inhibitor) combined with either sitravatinib or anlotinib in patients with extensive-stage small-cell lung cancer (ES-SCLC) who had undergone first-line (1L) tislelizumab plus chemotherapy induction. ES-SCLC treatment outcomes remain poor due to rapid progression after initial therapy, with median progression-free survival (PFS) typically under 6 months. The trials aimed to enhance maintenance therapy by adding anti-angiogenic agents to immunotherapy to potentially delay disease progression.<br /><br />Patient cohorts in both trials had poor prognosis features, with ECOG performance status mostly 1 and multiple metastatic sites. After induction therapy, 18 patients entered maintenance in each trial. Median follow-up times for maintenance were 9.5 to 17 months. <br /><br />Key efficacy findings included median PFS from maintenance start of 6.4 months in the tislelizumab+sitravatinib trial and 7.8 months in the tislelizumab+anlotinib trial; pooled median PFS was 6.9 months. Median overall survival (OS) was 18.3 months in the sitravatinib group and was not reached in the anlotinib group. From induction start, median PFS was 9.1-10.8 months and median OS ranged from 17.6 months to not reached. Objective response rates (ORR) during maintenance phase were 22.2% and 16.7% respectively, with high rates of continued tumor remission (up to 72.2%). From induction, ORR was markedly higher (76-86%).<br /><br />Regarding safety, treatment-related adverse events (TRAEs) of grade 3 or higher occurred in 56% of patients on sitravatinib and 14% on anlotinib during maintenance, but no TRAEs led to treatment discontinuation or death. Common side effects included elevated liver enzymes, hypothyroidism, proteinuria, anemia, hand-foot syndrome, and hypertension.<br /><br />In conclusion, maintenance with tislelizumab plus either sitravatinib or anlotinib after 1L chemo-immunotherapy demonstrated promising PFS and OS with manageable safety profiles in ES-SCLC patients. This combination approach leveraging PD-1 inhibition and anti-angiogenic therapy appears to be a clinically viable and effective strategy to delay disease progression and improve survival outcomes in this high-risk population.

Asset Subtitle

Yun Fan

Meta Tag

Speaker Yun Fan

Topic Small Cell Lung Cancer and Neuroendocrine Tumors

Keywords

tislelizumab

sitravatinib

anlotinib

extensive-stage small-cell lung cancer

ES-SCLC

maintenance therapy

PD-1 inhibitor

progression-free survival

overall survival

anti-angiogenic agents