Lenvatinib in Patients With Advanced Grade 1/2 Pancreatic and Gastrointestinal Neuroendocrine Tumors: Results of the Phase II TALENT Trial (GETNE1509)

• DOI: 10.1200/jco.20.03368
• Publication Date: 2021-05-04T20:10:17Z
• Authors: Jaume Capdevila; Nicola Fazio; Carlos Lopez; Alexandre Teulé; Juan W. Valle; Salvatore Tafuto; Ana Custodio; Nicholas Reed; Markus Raderer; Enrique Grande; Rocio Garcia-Carb...; Paula Jimenez-Fon...; Jorge Hernando; Alberto Bongiovanni; Francesca Spada; Vicente Alonso; Lorenzo Antonuzzo; Andrea Spallanzani; Alfredo Berruti; Adelaida La Casta; Isabel Sevilla; Patrizia Kump; Dario Giuffrida; Xavier Merino; Lorena Trejo; Pablo Gajate; Ignacio Matos; Angela Lamarca; Toni Ibrahim
• Keywords: Lenvatinib

PURPOSE Approved systemic therapies for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) have shown limited capacity to reduce tumor burden and no antitumor activity after progression targeted agents (TAs). We investigated the efficacy safety of lenvatinib in patients with previously treated GEP-NETs. PATIENTS AND METHODS This was a multicenter, single-arm, open-label, phase II trial two parallel cohorts (ClinicalTrials.gov identifier: NCT02678780 ) involving 21 institutions 4 European countries. Eligible had histologically confirmed grade 1-2 pancreatic (panNET) or GI (GI-NET) NETs documented treatment TA somatostatin analogs (GI-NET). Patients were 24 mg once daily until disease intolerance. The primary end point overall response rate by central radiology review. Secondary points included progression-free survival, duration response, safety. RESULTS Between September 2015 March 2017, total 111 enrolled, 55 56 each cohort. median follow-up 23 months. 29.9% (95% CI, 21.6 39.6): 44.2% 16.4% (range) 19.9 (8.4-30.8) 33.9 (10.6-38.3) months panNET GI-NET groups, respectively. survival 15.7 14.1 19.5). most common adverse events fatigue, hypertension, diarrhea; 93.7% required dose reductions interruptions. CONCLUSION report highest centrally reported date multikinase inhibitor GEP-NETs, particularly strong study provides novel evidence following other TAs, suggesting potential value