Phase II study of pembrolizumab and lenvatinib in advanced well-differentiated neuroendocrine tumors

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Introduction: Immune checkpoint inhibitors have not been shown to be active in well-differentiated NETs, with response rates <5%. Lenvatinib is a multitargeted TKI which targets VEGF and FGF receptors and has been reported to be effective in pancreatic and gastrointestinal NETs (40% and 18.5% ORR, respectively). The combination of antiangiogenic and checkpoint inhibitor therapies can be synergistic in other cancers.

Aim(s): Evaluating the combination of lenvatinib and pembrolizumab in well-differentiated GI and thoracic NETs.

Materials and methods: A prospective, phase II trial evaluated patients with advanced GI/thoracic NETs (pancreatic NETs were excluded due to high response rate of lenvatinib monotherapy in this patient population), with evidence of progression within 8 months of study entry and at least two prior lines of systemic therapy. Patients received lenvatinib 20mg daily and pembrolizumab 200mg IV every three weeks until unacceptable toxicity or progression of disease. Primary endpoint was objective response rate, and an interim analysis was planned once 20 patients were enrolled. 4 ORRs were required to continue enrolment.

Conference:

Presenting Author: Strosberg J

Authors: Strosberg J, Al-Toubah T, Morse B, Haider M, Valone T,

Keywords: pembrolizumab, lenvatinib, neuroendocrine tumor, immunotherapy,