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Clinical Trial
. 2025 Jul;36(4):e117.
doi: 10.3802/jgo.2025.36.e117.

Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma: the Asian cohort of the AtTEnd/ENGOT-EN7 trial

Kenichi Harano  1 , Roldano Fossati  2 , Beatriz Pardo  3 , Francesca Galli  2 , Emma Hudson  4 , Yoland Antill  5 , Chulmin Lee  6 , Manuela Rabaglio  7 , Florian Heitz  8 , Vassiliki Kolovetsiou-Kreiner  9 , Chyong-Huey Lai  10 , Elena Biagioli  11 , Luis Manso  12 , Shin Nishio  13 , Karen Allan  14 , Yeh Chen Lee  15 , Sara Uggeri  16 , Andres Redondo  17 , Satoshi Nakagawa  18 , Eunice Au  14 , Janine Lombard  19 , Angiolo Gadducci  20 , Kazuhiro Takehara  21 , Edi Editta Baldini  22 , Innocenza Palaia  23 , Claudia Casanova  24 , Antonio Ardizzoia  25 , Alessandra Bologna  26 , Maria-Pilar Barretina-Ginesta  27 , Nicoletta Colombo  28
Affiliations
Clinical Trial

Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma: the Asian cohort of the AtTEnd/ENGOT-EN7 trial

Kenichi Harano et al. J Gynecol Oncol. 2025 Jul.

Abstract

Objective: This post-hoc analysis of the AtTEnd trial explored differences in the prognostic characteristics and in the efficacy of atezolizumab between Asians and non-Asians.

Methods: The role of Asian race was evaluated on progression-free survival (PFS) using Cox-models and on time to appearance of new lesions using Fine and Gray models.

Results: From October 2018 to February 2022, 549 patients were randomized, of whom, 20.4% were Asian. Asians showed a better prognostic profile in terms of age, body mass index, Eastern Cooperative Oncology Group performance status, disease status and previous treatments. The prognostic impact of Asian race on PFS was confirmed in the placebo arm (adjusted hazard ratio [HR]=0.41; 95% confidence interval [CI]=0.24-0.70). In proficient mismatch repair (pMMR) tumors, the HRs for PFS comparing atezolizumab versus placebo were 0.82 (95% CI=0.63-1.05) in non-Asians, and 1.42 (95% CI=0.80-2.50) in Asians. In the pMMR population randomized to atezolizumab, the subdistribution HRs comparing Asians to non-Asians were 0.68 (95% CI=0.43-1.09) for progression with new lesions and 1.21 (95% CI=0.73-2.03) for progression without new lesions. Asians showed a higher occurrence of severe adverse events in atezolizumab compared to placebo arm (Asians: 82.1% vs. 64.3%, p=0.036; non-Asian: 63.3% vs. 63.6%, p=0.949).

Conclusion: Race seems to affect the safety of the addition of atezolizumab and, in pMMR tumors, also its efficacy. In the atezolizumab arm, Asian patients seem to have a lower cumulative incidence of new lesions when primary tumor regrowth was considered a competing risk, and a higher cumulative incidence of primary tumor regrowth when new lesions appearance was the competing risk.

Trial registration: ClinicalTrials.gov Identifier: NCT03603184.

Keywords: Asian; Atezolizumab; Endometrial Carcinoma; Mismatch Repair.

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Conflict of interest statement

Conflict of Interest: KH reports personal fees and grants/research support from AstraZeneca from AstraZeneca, Chugai, MSD/Merck, Taiho, Takeda, and Daiichi-Sankyo.

RF, FG, EB and SU report grants from Roche to their institution to support the conduct of the study.

BP reports personal fees from GSK, AstraZeneca, MSD, Pharma&.

EH reports personal fees from GSK, Clovis.

YA reports personal fee form AstraZeneca, Glaxo Smith Klein, MSD/Merck, Eisai, and grants/research support from AstraZeneca.

FH reports personal fees from NovoCure, PharmaMar, AstraZeneca, Roche, Tesaro, GSK, Zailab. MSD/Merck, Abbvie.

VK reports personal fees from AbbVie, AstraZeneca, Eisai, Roche, Gilead, Eli Lilly, Novartis, MSD/Merck, Pfizer, Daiichi Sankyo, GSK.

CHL reports personal fees from AstraZeneca, TTY Biopharm, Alkermes, Daiichi Sankyo, MSD/Merck, Gilead, GSK, Novartis and grants/research support from MSD, Daiichi Sankyo, Gilead.

LM reports personal fees from AstraZeneca, Eisai, GSK, MSD.

YL reports personal fees from AstraZeneca, Eisai, GSK and grants/research support from BeiGene.

AR reports personal fees from AstraZeneca, GSK, MSD/Merck, Pharma&.

JL reports personal fees from AstraZeneca, Gilead, Eisai, Novartis, GSK.

KT reports personal fees from AstraZeneca, Takeda, MSD/Merck, Eisai, Sanofi.

AA reports personal fees from Lilly, Serviert and Novartis.

AB reports personal fees from Eisai, GSK, MSD/Merck, and AstraZeneca, and grants/research support from Eisai, GSK and MSD/Merck.

MB reports personal fees from AstraZeneca, MSD/Merck, Pharma&, GSK, Eisai, Regeneron, Abvie.

NC reports personal fees from AstraZeneca, Eisai, GSK, MSD/Merck, Clovis Oncology, ImmunoGen, Mersana, Nuvation Bio, Onxerna, Pfizer, Roche, PharmaMar, Pieris, Roche, Biontech, Gilead and Novocure, and grants/research support from AstraZeneca and Roche.

CL, MR, SN, KA, SNakagawa, EA, AG, EEB, IP, CC have nothing to disclose.

This clinical trial update is an original submission; however, some results were presented in an oral presentation at the European Society of Gynecological Oncology (ESGO) Annual Meeting 2024 (Nishio et al. Int J Gynecol Cancer 2024;34:A20-A21). The Mario Negri Institute for Pharmacological Research of Milan, Italy is the legal entity responsible for the governance, coordination, and execution of the study on behalf of Mario Negri Gynecologic Oncology (MaNGO) group.

Figures

Fig. 1
Fig. 1. Flow chart of the study population.
dMMR, deficient mismatch repair; ITT, intention-to-treat; MMR, mismatch repair; pMMR, proficient mismatch repair.
Fig. 2
Fig. 2. Kaplan-Meier curves of PFS according to treatment arm and race. (A) dMMR subgroup and (B) pMMR subgroup.
CI, confidence interval; dMMR, deficient mismatch repair; PFS, progression-free survival; pMMR, proficient mismatch repair.
Fig. 3
Fig. 3. Cumulative incidence curves of progression.
Cumulative incidence curves of progression for (A) new lesions, (B) tumor regrowth in placebo arm according to race; cumulative incidence curves of progression for (C) new lesions, (D) tumor regrowth in atezolizumab arm according to race.
See this image and copyright information in PMC

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