Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer

Vicky Makker, Matthew H. Taylor, Carol Aghajanian, Ana Oaknin, James Mier, Allen L. Cohn, Margarita Romeo, Raquel Bratos, Marcia S. Brose, Christopher DiSimone, Mark Messing, Daniel E. Stepan, Corina E. Dutcus, Jane Wu, Emmett V. Schmidt, Robert Orlowski, Pallavi Sachdev, Robert Shumaker, Antonio Casado Herraez

    Research output: Contribution to journalArticlepeer-review

    12 Scopus citations

    Abstract

    PURPOSE Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors. METHODS Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORRWk24); secondary efficacy end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Tumor assessments were evaluated by investigators per immune-related RECIST. RESULTS At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORRWk24 was 38.0% (95% CI, 28.8% to 47.8%). Among subgroups, the ORRWk24 (95% CI) was 63.6% (30.8% to 89.1%) in patients with microsatellite instability (MSI)-high tumors (n = 11) and 36.2% (26.5% to 46.7%) in patients with microsatellite-stable tumors (n = 94). For previously treated patients, regardless of tumor MSI status, the median DOR was 21.2 months (95% CI, 7.6 months to not estimable), median PFS was 7.4 months (95% CI, 5.3 to 8.7 months), and median OS was 16.7 months (15.0 months to not estimable). Grade 3 or 4 treatment-related adverse events occurred in 83/124 (66.9%) patients. CONCLUSION Lenvatinib plus pembrolizumab showed promising antitumor activity in patients with advanced endometrial carcinoma who have experienced disease progression after prior systemic therapy, regardless of tumor MSI status. The combination therapy had a manageable toxicity profile.

    Original languageEnglish (US)
    Pages (from-to)2981-2992
    Number of pages12
    JournalJournal of Clinical Oncology
    Volume38
    Issue number26
    DOIs
    StatePublished - Sep 10 2020

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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