MedComm· 2026Q1
Efficacy and Safety of Lucitanib in Advanced Thymic Carcinoma: A Randomized Phase II Trial
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- Q1SCImago
- 2026year
Short summary
In a randomized trial (n=68) of advanced thymic carcinoma, lucitanib (10mg daily) significantly improved investigator-assessed progression-free survival (PFS) to 6.6 months vs. 1.9 months for placebo (HR: 0.53; p=0.0306), and showed a statistically significant benefit via restricted mean survival time analysis, despite not meeting the primary IRC-assessed PFS endpoint.
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Key points
- Lucitanib did not meet the primary endpoint for independent review committee-assessed progression-free survival (PFS) in advanced thymic carcinoma (5.8 vs. 3.7 months).
- Restricted mean survival time analysis and investigator-assessed PFS showed a statistically significant benefit for lucitanib (p < 0.05 and p=0.0306, respectively).
- Investigator-assessed PFS was substantially longer with lucitanib (6.6 months) compared to placebo (1.9 months).
- The most frequent grade 3 treatment-related adverse events were hypertension (50%), proteinuria (15.2%), and thrombocytopenia (8.7%).
AI-generated from the title and abstract; the full text is not read.
Abstract
ABSTRACT Advanced thymic carcinoma is a rare, aggressive malignancy with limited treatment options after chemotherapy failure. This randomized, double‐blind, placebo‐controlled trial (AL3810‐202) aimed to evaluate lucitanib, a novel, orally potent tyrosine kinase inhibitor targeting VEGFR1‒3, FGFR1‒3, and PDGFRα/β in patients with advanced thymic carcinoma progressing after chemotherapy. Sixty‐eight patients were randomized (2:1) to receive 10 mg lucitanib daily ( n = 46) or placebo ( n = 22). Although this study did not meet its primary endpoint of independent review committee (IRC)‐assessed progression‐free survival (PFS) (median 5.8 vs. 3.7 months; hazard ratio [HR]: 0.60; p = 0.1050), the prespecified log‐rank test may have underestimated the treatment effect due to an observed non‐proportional hazards pattern. Subsequent restricted mean survival time analysis demonstrated a statistically significant PFS benefit ( p < 0.05), which was further supported by significantly prolonged investigator‐assessed PFS (6.6 vs. 1.9 months; HR: 0.53; p = 0.0306). The most common grade 3 treatment‐related adverse events (TRAEs) were hypertension (50%), proteinuria (15.2%), and thrombocytopenia (8.7%), with no grade 4/5 events. Considering the totality of the evidence and an acceptable safety profile, lucitanib may confer a meaningful clinical benefit for patients with advanced thymic carcinoma, warranting further investigation.
The authors' abstract, as published at the source. MedComm, 2026 · DOI ↗
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Field: Neurology (Medicine)
NeurologyMedicine