Responses to Cabozantinib plus Atezolizumab in a wide population of advanced and progressive neuroendocrine neoplasms (NENs): A prospective multi-cohort basket phase II Trial (CABATEN / GETNE-T1914)

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Introduction: Angiogenesis plays a key role in development and progression of NENs and synergism has been observed when combined with immune-checkpoint inhibitors in other tumors.

Aim(s): We aimed to demonstrate the activity and safety of cabozantinib (C) plus atezolizumab (A) in advanced and progressive NENs.

Materials and methods: CABATEN was a single-arm basket study using A 1200 mg plus C 40 mg/day until progression or unacceptable toxicity in four NENs cohorts with different origins: well-differentiated lung neuroendocrine tumors (LungNET), malignant pheochromocytoma/paraganglioma (PPGL), well-differentiated gastroenteropancreatic NET (GEPNET) and grade 3 extrapulmonary neuroendocrine carcinomas (G3 EP-NEN). Primary endpoint was Overall Response Rate (ORR) by RECIST 1.1. The study had a Simon-II design. Here we present a subgroup analysis of efficacy for NENs (n=55) and for C reduction using a relative dose intensity (RDI)<81% threshold and 3-month interval by Landmark analysis.

Conference:

Presenting Author: Molina-Cerrillo J

Authors: Molina-Cerrillo J, Grande E, Benavent M, Garcia-Carbonero R, Teule A,

Keywords: neuroendocrine neoplasm, Cabozantinib, Atezolizumab, CABATEN, prospective multi-cohort Basket Phase II Trial,