Lenvatinib produced the highest response rate observed to date with a multikinase inhibitor in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to researchers.
The results, from the phase 2 TALENT trial (ClinicalTrials.gov Identifier: NCT02678780), were published in the Journal of Clinical Oncology.
The researchers noted that resistance to systemic therapies is a major challenge in patients with GEP-NETs. NET cells overexpress a range of proangiogenic molecules and receptors, and lenvatinib is known to have a broad antiangiogenic activity.
With this in mind, the researchers evaluated the efficacy of lenvatinib in patients with grade 1/2 GEP-NETs who had documented tumor progression after receiving targeted agents or somostatin analogs.
The study included 2 parallel cohorts. One cohort included 55 patients with pancreatic NETs (pan-NETs), and the other included 56 patients with gastrointestinal NETs (GI-NETs).
Patients in both cohorts received lenvatinib at 24 mg once daily until disease progression or treatment intolerance. The median follow-up was 23 months.
The overall response rate was 29.9% for the entire cohort, 44.2% in the pan-NET cohort, and 16.4% in the GI-NET cohort.
The median duration of response was 21.5 months overall, 19.9 months in the pan-NET cohort, and 33.9 months in the GI-NET cohort.
The median progression-free survival was 15.7 months overall, 15.6 months in the pan-NET cohort, and 15.7 months in the GI-NET cohort.
The median overall survival was 32 months in the pan-NET cohort and was not reached in the GI-NET cohort. In all, there were 37 deaths (33.3%).
The most common grade 1/2 adverse events (AEs) were asthenia, hypertension, diarrhea, dysphonia, and hypothyroidism. The most common grade 3/4 AEs were hypertension, asthenia, and diarrhea.
Treatment-related AEs led to discontinuation in 6 patients (10.9%) in the pan-NET cohort and 10 patients (17.8%) in the GI-NET cohort.
“We report the highest centrally confirmed response reported to date with a multikinase inhibitor in advanced GEP-NETs, with a particularly strong response in the pan-NET cohort,” the researchers wrote. “This study provides novel evidence for the efficacy of lenvatinib in patients with disease progression following treatment with other TAs [targeted agents], suggesting the potential value of lenvatinib in the treatment of advanced GEP-NETs.”
Disclosures: This research was supported by Eisai. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Capdevila J, Fazio N, Lopez C, et al. Lenvatinib in patients with advanced grade 1/2 pancreatic and gastrointestinal neuroendocrine tumors: results of the phase II TALENT trial (GETNE1509). J Clin Oncol.Published online May 4, 2021. doi:10.1200/JCO.20.03368