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FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma that has progressed following at least one prior systemic therapy.

This Breakthrough Therapy designation was based on interim results of the endometrial carcinoma cohort in Study 111/KEYNOTE-146, which were presented by Makker et al at the 2018 ASCO Annual Meeting (Abstract 5596). Study 111/KEYNOTE-146 is a multicenter, open-label, single-arm phase Ib/II basket trial evaluating the efficacy and safety of lenvatinib (20 mg/d) in combination with pembrolizumab (200 mg intravenously every 3 weeks) in patients with selected solid tumors (renal cell carcinoma, endometrial carcinoma, non–small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma).

More About Study 111/KEYNOTE-146

Patients enrolled in Study 111/KEYNOTE-146 were not preselected based on MSI or programmed death-ligand 1 (PD-L1) tumor biomarker status. The primary endpoint of the phase Ib study was to determine the maximum tolerated dose of lenvatinib and pembrolizumab in combination. The primary endpoint of the phase II portion is investigator-assessed objective response rate at week 24 based on immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). The secondary efficacy endpoints included objective response rate, progression-free survival, and duration of response for patients with complete or partial responses.

Fifty-three patients with previously treated, metastatic endometrial carcinoma were evaluated in the endometrial carcinoma cohort. Currently, the phase II part is ongoing as an endometrial carcinoma cohort expansion. This study is being conducted under an existing strategic collaboration between the two companies.

A randomized, international, two-arm phase III study in recurrent endometrial carcinoma is underway: Study 309/KEYNOTE-775.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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