Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Authors

Vicky Makker
Nicoletta Colombo
Antonio Casado Herráez
Bradley J Monk
Helen Mackay
Alessandro D Santin
David S Miller
Richard G Moore
Sally Baron-Hay
Isabelle Ray-Coquard
Kimio Ushijima
Kan Yonemori
Yong Man Kim
Eva M Guerra Alia
Ulus A Sanli
Steven Bird
Robert Orlowski
Jodi McKenzie
Chinyere Okpara
Gianmaria Barresi
Domenica Lorusso

Language

English

Publication Date

6-1-2023

Journal

Journal of Clinical Oncology

DOI

10.1200/JCO.22.02152

PMID

37058687

PMCID

PMC10414727

PubMedCentral® Posted Date

4-14-2023

PubMedCentral® Full Text Version

Post-print

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m² intravenously once every 3 weeks or paclitaxel 80 mg/m² intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.

Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Keywords

Female, Humans, Antibodies, Monoclonal, Humanized, Endometrial Neoplasms, Phenylurea Compounds, Antineoplastic Combined Chemotherapy Protocols, Quinolines

Published Open-Access

yes

Recommended Citation

Makker, Vicky; Colombo, Nicoletta; Casado Herráez, Antonio; et al., "Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775" (2023). Faculty, Staff and Student Publications. 6371.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/6371