Phase 2 trial of anlotinib plus toripalimab maintenance therapy in extensive-stage small cell lung cancer

A phase 2 trial at Taizhou University (Zhejiang, China) evaluated maintenance therapy with toripalimab plus anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC) who achieved disease control after first-line platinum-etoposide chemotherapy. The trial enrolled 20 patients who received toripalimab 240 mg every 3 week plus anlotinib 12 mg on days 1-14 of 21 day cycles until disease progression or unacceptable toxicity. This maintenance therapy resulted in a median progression-free survival of 13.6 months from initial treatment and 8.18 months during the maintenance phase, and median overall survival of 23.05 months. The combination exhibited a manageable safety profile. Preclinical analyses suggested that the therapeutic effect of the combination may be mediated through coordinated immunomodulation and anlotinib-induced changes in differentiation-related pathways. The authors conclude that anlotinib plus toripalimab maintenance therapy for ES-SCLC warrants further validation in randomized controlled trials.