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546 AtTEnd/ENGOT-EN7: phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma
  1. Nicoletta Colombo1,
  2. Kenichi Harano2,
  3. Emma Hudson3,
  4. Francesca Galli4,
  5. Yoland Antill5,
  6. Chel Hun Choi6,
  7. Manuela Rabaglio7,
  8. Frederik Marmé8,
  9. Edgar Petru9,
  10. Chyong-Huey Lai10,
  11. Elena Biagioli4,
  12. Lorena Fariñas-Madrid11,
  13. Kazuhiro Takehara12,
  14. Karen Allan13,
  15. Yeh Chen Lee14,
  16. Elisa Piovano15,
  17. Claudio Zamagni16,
  18. Giulia Tasca17,
  19. Annamaria Ferrero18 and
  20. Maria-Pilar Barretina-Ginesta19
  1. 1Department of Gynecology, European Institute of Oncology, IEO, IRCCS, Milan, Italy
  2. 2National Cancer Center Hospital East, Kashiwa, Japan
  3. 3Velindre Cancer Centre, Velindre NHS Trust, Cardiff, UK
  4. 4Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
  5. 5Peninsula Health, Monash University, Melbourne, Australia
  6. 6Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, South Korea
  7. 7INSELSPITAL, University Hospital Bern, Bern, Switzerland
  8. 8Obstetrics and Gynecology Section GynecologicOncology, UMM – Universitaetsklinikum Mannheim – Medizinische Fakultaet, Mannheim, Germany
  9. 9Department of Obstetrics and Gynecology Medical University of Graz, Graz, Austria
  10. 10Chang Gung Memorial Hospital, Linkou branch, Taoyuan, Taiwan
  11. 11Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
  12. 12National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
  13. 13Cancer Research UK Glasgow Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, UK
  14. 14NHMRC Clinical Trials Centre, Sydney University, Sydney, Australia
  15. 15SCDU Ginecologia e Ostetricia 2U, Ospedale Sant’Anna, AOU Città della Salute e della Scienza di Torino, Torino, Italy
  16. 16IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
  17. 17Veneto Institute of Oncology IOV – IRCCS, Padua, Italy
  18. 18SCDU Ginecologia e Ostetricia, AO Ordine Mauriziano, Torino, Italy
  19. 19Catalan Institute of Oncology, Girona, Spain


Introduction/Background The standard therapy for advanced/recurrent endometrial cancer includes carboplatin and paclitaxel (CP). Robust biological rationale suggested a synergy between immunotherapy and chemotherapy in this setting.

Methodology AtTEnd is an academic study in advanced or recurrent endometrial carcinoma/carcinosarcoma patients with no prior systemic chemotherapy for recurrence. Patients were randomized (2:1 ratio) to receive either CP and atezolizumab or placebo, followed by atezolizumab or placebo until disease progression. The mismatch repair (MMR) status was evaluated centrally. Coprimary endpoints with a hierarchical approach were: progression free survival (PFS) in the deficient MMR (dMMR) population, PFS and overall survival (OS) in all comers.

Results From Oct 2018 to Jan 2022 551 patients were enrolled across 10 countries (median follow-up 28.3 months). Of the 549 patients included in the intention to treat population, 125 (22.8%) had dMMR tumours and 352 (64.1%) had endometrioid carcinoma; 369 (67.2%) had recurrent disease and 148 (82.2%) of newly diagnosed cases had primary stage IV. In the dMMR population, the addition of atezolizumab showed a significant improved PFS (HR 0.36 95% CI:0.23–0.57; p=0.0005; median PFS: not reached vs. 6.9 months for atezolizumab vs placebo). The superiority in PFS was confirmed in all comers (HR 0.74 95%CI:0.61–0.91; p=0.0219; median PFS: 10.1 months vs 8.9 months for atezolizumab vs placebo). Interim analysis of OS in all comers indicated a trend in favor for atezolizumab, despite 45 (24.3%) placebo patients received immunotherapy as subsequent therapy. Duration of response in the dMMR population confirmed the efficacy of atezolizumab. Grade≥3 adverse events occurred in 66.9% and 63.8% of patients in atezolizumab vs placebo arm. Safety profile for CP + atezolizumab was manageable and consistent with expected toxicities.

Conclusion The addition of atezolizumab to standard chemotherapy demonstrated a statistically significant improvement in PFS for patients with advanced/recurrent endometrial carcinomas with a substantial benefit in dMMR carcinomas.

Disclosures 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. The study is funded by F. Hoffmann-La Roche Ltd. The trial protocol number is NCT03603184; 2018–001072-37.

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