Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer Journal Article

   


Authors: Makker, V.; Taylor, M. H.; Aghajanian, C.; Oaknin, A.; Mier, J.; Cohn, A. L.; Romeo, M.; Bratos, R.; Brose, M. S.; DiSimone, C.; Messing, M.; Stepan, D. E.; Dutcus, C. E.; Wu, J.; Schmidt, E. V.; Orlowski, R.; Sachdev, P.; Shumaker, R.; Herraez, A. C.
Article Title: Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer
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. (C) 2020 by American Society of Clinical Oncology.
Keywords: inhibitor; carcinoma; trial; recurrent; criteria; burden; antitumor activities; e7080
Journal Title: Journal of Clinical Oncology
Volume: 38
Issue: 26
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2020-09-10
Start Page: 2981
End Page: 2992
Language: English
ACCESSION: WOS:000574584300001
DOI: 10.1200/jco.19.02627
PROVIDER: wos
PMCID: PMC7479759
PUBMED: 32167863
Notes: Article -- Source: Wos
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MSK Authors
  1. Vicky Makker
    263 Makker
  2. Carol A Aghajanian
    607 Aghajanian
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