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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Approved in Japan for Patients With Unresectable, Advanced or Recurrent Endometrial Carcinoma That Progressed After Cancer Chemotherapy

Published date:
12/24/2021
Excerpt:
...Eisai...and Merck & Co., Inc.,...today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Title:

European Commission Approves LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

Published date:
11/29/2021
Excerpt:
Eisai Co...and Merck & Co., Inc...today announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
07/21/2021
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/20/2020
Excerpt:
Systemic Therapy for Endometrial Carcinoma...Recurrent, Metastatic or High-risk Disease...Biomarker-directed systemic therapy for second-line treatment...lenvatinib/pembrolizumab.
Evidence Level:
Sensitive: B - Late Trials
Title:

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

Published date:
04/14/2023
Excerpt:
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.
DOI:
10.1200/JCO.22.02152
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer

Published date:
01/19/2022
Excerpt:
The median progression-free survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 6.6 vs. 3.8 months; hazard ratio for progression or death, 0.60; 95% confidence interval [CI], 0.50 to 0.72; P<0.001; overall: 7.2 vs. 3.8 months; hazard ratio, 0.56; 95% CI, 0.47 to 0.66; P<0.001). The median overall survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 17.4 vs. 12.0 months; hazard ratio for death, 0.68; 95% CI, 0.56 to 0.84; P<0.001; overall: 18.3 vs. 11.4 months; hazard ratio, 0.62; 95% CI, 0.51 to 0.75; P<0.001).
DOI:
10.1056/NEJMoa2108330
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Merck and Eisai Receive Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Two Different Types of Cancer

Published date:
10/15/2021
Excerpt:
The positive CHMP opinions are based on data from two pivotal Phase 3 trials: CLEAR (Study 307)/KEYNOTE-581 evaluating the combination in adult patients with advanced RCC and KEYNOTE-775/Study 309 evaluating the combination in certain patients with advanced EC....KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of overall survival (OS)...
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Merck and Eisai Receive Priority Review From FDA for KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Applications for Advanced Renal Cell Carcinoma and for Advanced Endometrial Carcinoma

Published date:
05/06/2021
Excerpt:
Merck...and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA....The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on PFS, OS and ORR data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial.
Trial ID: