A retrospective real-world study on the efficacy and safety of anlotinib in combination with immunotherapy as maintenance therapy after standard immunochemotherapy for extensive-stage small cell lung cancer (ALTER-L059).

Abstract

8080 Background: Although immune checkpoint inhibitors (ICIs) combined with chemotherapy have become the standard first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), the use of immunotherapy as a maintenance strategy remains challenging. This study aims to evaluate the efficacy and safety of anlotinib combined with ICIs as first-line maintenance treatment for ES-SCLC. Methods: ALTER-L059 was a retrospective, multicenter study conducted at 9 hospitals in China. Eligible patients were 18 years or older with histologically or cytologically confirmed ES-SCLC and had completed 4–6 cycles of first-line immunochemotherapy as induction therapy without disease progression. They subsequently received maintenance therapy with immunotherapy combined with anlotinib. The primary endpoint was progression-free survival from the start of maintenance therapy (PFS2). Secondary endpoints included progression-free survival from the start of induction therapy (PFS), overall survival from the start of maintenance therapy (OS2), overall survival from the start of induction therapy (OS) and safety. Results: Between January 2022 and December 2024, a total of 100 patients were enrolled. By the data cutoff date on November 11, 2025, the median follow-up duration was 16.92 months (95% CI: 15.81-18.03). The median PFS2 was 6.05 months (95% CI: 4.83-7.59), and the median PFS was 9.53 months (95% CI: 8.31-11.93). The median OS2 was 17.74 months (95% CI: 15.24-19.71), and the median OS was 21.26 months (95% CI: 18.60-22.60). The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 30.0%. The most common TRAEs (incidence ≥20%) were hypertension (33.0%), hand-foot syndrome (23.0%), proteinuria (21.0%), and hypertriglyceridemia (20.0%). Conclusions: Patients who had been diagnosed with ES-SCLC and had completed 4–6 cycles of immunochemotherapy as induction therapy without disease progression subsequently received maintenance therapy with immunotherapy combined with anlotinib, demonstrating favorable survival outcomes and manageable toxicity. Clinical trial information: NCT06982287 .