ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F24%3A43927554" target="_blank" >RIV/00064173:_____/24:43927554 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/24:10485492 RIV/00216208:11120/24:43927554 RIV/00064165:_____/24:10485492

Result on the web

<a href="https://doi.org/10.1016/j.annonc.2024.08.2242" target="_blank" >https://doi.org/10.1016/j.annonc.2024.08.2242</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.annonc.2024.08.2242" target="_blank" >10.1016/j.annonc.2024.08.2242</a>

Result language

angličtina

Original language name

ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer

Original language description

BACKGROUND: Pembrolizumab plus chemotherapy provides clinically meaningful benefit as first-line therapy for advanced (locoregional extension and residual disease after surgery)/metastatic/recurrent pMMR and dMMR endometrial cancer (EC), with greater magnitude of benefit in the dMMR phenotype. We evaluated addition of pembrolizumab to adjuvant chemotherapy (with/without radiation therapy) among patients with newly-diagnosed, high-risk EC without any residual macroscopic disease following curative-intent surgery. METHODS: Patients with histologically confirmed high-risk (FIGO stage I/II of non-endometrioid histology or endometrioid histology with p53/TP53 abnormality, or stage III/IVA of any histology) EC following surgery with curative intent and no evidence of disease postoperatively, with no prior radiotherapy or systemic therapy. Patients were randomised to pembrolizumab 200mg or placebo Q3W for 6 cycles added to carboplatin-paclitaxel followed by pembrolizumab 400mg or placebo Q6W for 6 cycles per treatment assignment. Radiotherapy was at the investigator&apos;s discretion. Primary endpoints were investigator-assessed disease-free survival (DFS) and overall survival in the intention-to-treat population. RESULTS: 1095 patients were randomised (pembrolizumab, n=545; placebo, n=550). At this interim analysis (data cutoff, 4-March2024), 119 (22%) DFS events occurred in the pembrolizumab group and 121 (22%) occurred in the placebo group (hazard ratio, 1.02 [95% CI, 0.79-1.32]; P=0.570). Kaplan-Meier estimates of 2-year DFS rates were 75% and 76% in the pembrolizumab and placebo groups, respectively. The hazard ratio for DFS was 0.31 (95% CI, 0.14-0.69) in the dMMR population (n=281) and 1.20 (95% CI, 0.91-1.57) in the pMMR population (n=814). Grade &gt;=3 adverse events (AEs) occurred in 386 of 543 (71%) and 348 of 549 (63%) patients in the pembrolizumab and placebo groups, respectively. No treatment-related grade 5 AEs occurred. CONCLUSION: Adjuvant pembrolizumab plus chemotherapy did not improve DFS in patients with newly-diagnosed, high-risk, all-comer EC. Preplanned subgroup analyses for stratification factors suggests pembrolizumab plus chemotherapy improved DFS in patients with dMMR tumours. Safety was manageable.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30214 - Obstetrics and gynaecology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Annals of Oncology

ISSN

0923-7534

e-ISSN

1569-8041

Volume of the periodical

35

Issue of the periodical within the volume

11

Country of publishing house

GB - UNITED KINGDOM

Number of pages

13

Pages from-to

968-980

UT code for WoS article

001353629400001

EID of the result in the Scopus database

2-s2.0-85205537265