Safety and Efficacy of Lucitanib Plus Toripalimab in Advanced Solid Tumors Refractory to Standard Therapies: An...

Area of Science:

• Oncology
• Pharmacology
• Immunotherapy

Background:

• Lucitanib is a novel multi-target inhibitor targeting VEGFR, FGFR, and PDGFR signaling pathways.
• Advanced solid tumors often become refractory to standard therapies, necessitating novel treatment strategies.
• Combining targeted therapy with immune checkpoint inhibitors like toripalimab (anti-PD-1) may enhance anti-tumor responses.

Purpose of the Study:

• To evaluate the efficacy and safety of lucitanib combined with toripalimab in patients with advanced solid tumors refractory to standard treatments.
• To assess objective response rate (ORR), progression-free survival (PFS), and safety across different tumor types, including nasopharyngeal carcinoma (NPC) and endometrial cancer (EC).

Main Methods:

• An open-label, multicenter, single-arm Phase II study.
• 131 patients with advanced solid tumors received lucitanib (10 mg daily) plus toripalimab (240 mg every 3 weeks).
• Endpoints included investigator-assessed ORR, duration of response, PFS, overall survival, and safety.

Main Results:

• The overall objective response rate (ORR) was 34.1% across all cohorts.
• Higher ORRs were observed in PD-1-naïve nasopharyngeal carcinoma (45.8%) and endometrial cancer (38.5%).
• Common Grade ≥ 3 treatment-related adverse events included hypertension (37.4%), proteinuria (10.7%), and thrombocytopenia (10.7%).

Conclusions:

• Lucitanib plus toripalimab demonstrated encouraging antitumor activity and a manageable safety profile in heavily pretreated advanced solid tumors.
• The combination therapy warrants further randomized evaluation, especially in nasopharyngeal carcinoma and endometrial cancer.
• The study provides a basis for further clinical investigation of this combination in specific advanced solid tumor indications.