Toripalimab plus anlotinib maintenance shows promise in ES-SCLC after first-line chemo
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Key Takeaway
Consider that toripalimab plus anlotinib maintenance may improve outcomes in ES-SCLC, but data are preliminary from a small single-arm trial.
This multi-center, single-arm, open-label phase II trial (preprint) evaluated maintenance therapy with toripalimab (240mg every 3 weeks) plus anlotinib (12mg orally on days 1-14 of each 21-day cycle) in 20 patients with extensive-stage small cell lung cancer (ES-SCLC) who achieved disease control after first-line platinum-etoposide chemotherapy.
Median progression-free survival (mPFS) from initial treatment was 13.6 months, and mPFS during the maintenance phase was 8.18 months. Median overall survival (mOS) was 23.05 months. Serum neuroendocrine markers (NSE and ProGRP) were reduced post-treatment.
The safety profile was described as manageable, though specific adverse events, serious adverse events, and discontinuations were not reported. The single-arm design is a key limitation, and results warrant further validation in randomized controlled trials.
While these findings suggest potential benefit, the lack of a comparator and small sample size limit definitive conclusions. The observed association between reduced serum NE markers and improved survival is preliminary and requires confirmation. Clinicians should interpret these results cautiously until larger, controlled studies are available.
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View Original Abstract ↓
PURPOSE: To evaluate the efficacy, safety and underlying mechanisms of toripalimab combined with anlotinib as maintenance therapy in patients with extensive-stage small cell lung cancer (ES-SCLC) who achieved disease control after first-line platinum-etoposide chemotherapy.
EXPERIMENTAL: Design: A multi-center, single-arm, open-label phase II trial (NCT04363255) enrolled 20 patients with ES-SCLC. Participants received maintenance therapy with toripalimab (240mgevery3weeks) plus anlotinib (12mgorallyondays1-14ofeach21-daycycle) until disease progression or unacceptable toxicity. Preclinical studies were conducted using SCLC cell lines to investigate the effects of anlotinib on PD-L1 expression, immune checkpoint regulation and neuroendocrine (NE) differentiation.
RESULTS: The combination therapy resulted in a median progression-free survival (mPFS) of 13.6 months from initial treatment and 8.18 months during the maintenance phase. Median overall survival (mOS) reached 23.05 months. Preclinical studies demonstrated that anlotinib promoted dose-dependent PD-L1 upregulation through de novo protein synthesis and enhanced surface expression. Transcriptomic analyses revealed broad immunomodulatory effects, including activation of Notch signaling and upregulation of multiple immune checkpoints. Anlotinib also altered gene expression programs associated with NE differentiation and epithelial-mesenchymal transition (EMT). These findings were accompanied clinical observation, reduced post-treatment levels of serum NE markers (NSE and ProGRP) were significantly correlated with improved survival. The combination exhibited a manageable safety profile.
CONCLUSIONS: Toripalimab plus anlotinib is associates with promising efficacy and acceptable safety as maintenance therapy in ES-SCLC. The therapeutic effect may be mediated through coordinated immunomodulation and anlotinib-induced changes in differentiation-related pathway, providing a mechanistic rationale for the observed clinical benefits. These results warrant further validation in randomized controlled trials.
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