A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma

• Published in: The oncologist (Dayton, Ohio) Vol. 27; no. 6; pp. e453 - e462
• Main Authors: Zhang, Yang, Luo, Fan, Ma, Yu-Xiang, Liu, Qian-Wen, Yang, Yun-Peng, Fang, Wen-Feng, Huang, Yan, Zhou, Ting, Li, Jin, Pan, Hong-Ming, Yang, Lei, Qin, Shu-Kui, Zhao, Hong-Yun, Zhang, Li
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 08.06.2022
• Subjects: Antimitotic agents; Antineoplastic agents; Cancer; Clinical Trial Results; Development and progression; Drug therapy; Genetic aspects; Humans; Metastasis; Naphthalenes; Nasopharyngeal cancer; Nasopharyngeal Carcinoma - drug therapy; Nasopharyngeal Neoplasms - drug therapy; Nasopharyngeal Neoplasms - pathology; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - genetics; Oncology, Experimental; Patient outcomes; Pharmaceutical research; Quinolines - therapeutic use; China; anti-angiogenic therapy; kinase inhibitor; phase I trial; nasopharyngeal carcinoma; AL3810
• ISSN: 1083-7159; 1549-490X; 1549-490X
• DOI: 10.1093/oncolo/oyab076

Abstract Background Lucitanib is a novel multi-target inhibitor of FGFR1-3, VEGFR 1-3, and PDGFR α/β. Here, we evaluated the safety, tolerability, and preliminary efficacy of lucitanib in recurrent and metastatic nasopharyngeal carcinoma (RM-NPC). Methods Patients with pretreated RM-NPC were randomly divided into two treatment arms: continuous or intermittent treatment. The primary endpoint was safety and tolerability. Secondary endpoints were objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Results One hundred percent of patients in the continuous arm and 90% of patients in the intermittent arm had at least one treatment-related AE (TRAE). Grade ≥3 related TRAEs occurred in 5 patients in the continuous arm (5/10, 50%). No TRAEs grade >3 occurred in the intermittent arm. The ORR and DCR of the continuous arm was 20% and 90%, and the intermittent arm was 10% and 60%, respectively. All responses were observed by the first evaluation. The duration of response was more than 1 year, with two patients still on treatment with sustained response at more than 3 years. Conclusion Lucitanib has promising clinical activity and tolerable safety profile in heavily pretreated patients with NPC. Patients who responded to lucitanib treatment generally achieved a long DoR. Lucitanib is now being evaluated in phase II/III studies. ClinicalTrials.gov identifier NCT03260179 This article evaluates the safety, tolerability, and preliminary efficacy of lucitanib in recurrent and metastatic nasopharyngeal carcinoma.