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427 BEATcc (ENGOT-CX10/GEICO 68-C/JGOG1084/GOG-3030), a randomised phase 3 trial of first-line atezolizumab with bevacizumab and platinum-based chemotherapy for metastatic (stage IVB), persistent or recurrent cervical cancer
  1. Ana Oaknin1,
  2. Laurence Gladieff2,
  3. Jerónimo Martínez3,
  4. Guillermo Villacampa4,
  5. Munetaka Takekuma5,
  6. Ugo De Giorgi6,
  7. Kristina Lindemann7,
  8. Linn Woelber8,
  9. Nicoletta Colombo9,
  10. Linda R Duska10,
  11. Alexandra Leary11,
  12. Ana Godoy-Ortiz12,
  13. Shin Nishio13,
  14. Antoine Angelergues14,
  15. María Jesús Rubio15,
  16. Lorena Fariñas-Madrid1,
  17. Satoshi Yamaguchi16,
  18. Domenica Lorusso17,
  19. Véronique D’hondt18 and
  20. Leslie M Randall19
  1. 1GEICO and Medical Oncology Service, Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  2. 2GINECO and Oncopole Claudius Regaud, IUCT, Toulouse, France
  3. 3GEICO and Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
  4. 4Vall d’Hebron Institute of Oncology (VHIO) and SOLTI Breast Cancer Research Group, Barcelona, Spain
  5. 5JGOG and Shizuoka Cancer Center, Shizuoka, Japan
  6. 6MITO and IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy
  7. 7NSGO-CTU and Institute of Clinical Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway
  8. 8AGO and University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  9. 9MaNGO and Department of Gynecology, European Institute of Oncology IRCCS Milan and University of Milan-Bicocca, Milan, Italy
  10. 10GOG-F and University of Virginia Cancer Center, Charlottesville, USA
  11. 11GINECO and Gustave Roussy, Villejuif, France
  12. 12GEICO and UGCI Oncología Médica Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain
  13. 13JGOG and Kurume University Hospital, Fukuoka, Japan
  14. 14GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
  15. 15GEICO and Hospital Universitario Reina Sofia, Córdoba, Spain
  16. 16JGOG and Hyogo Cancer Center, Hyogo, Japan
  17. 17MITO and Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy
  18. 18GINECO and Institut du Cancer de Montpellier, Montpellier, France
  19. 19GOG-F and Massey Comprehensive Cancer Center, VCUHealth, Richmond, USA


Introduction/Background The GOG 240 trial established bevacizumab plus chemotherapy as standard first-line therapy for metastatic (stage IVB), persistent or recurrent cervical cancer (R/M CC). The investigator-initiated open-label randomised phase 3 BEATcc trial (NCT03556839) evaluated atezolizumab (anti-PD-L1) combined with this standard regimen, irrespective of PD-L1 status.

Methodology Patients with previously untreated measurable R/M CC not amenable to curative surgery/radiation were randomised 1:1 to standard therapy (cisplatin 50 mg/m2 or carboplatin AUC5, paclitaxel 175 mg/m2 and bevacizumab 15 mg/kg) with or without atezolizumab (1200 mg day 1 every 3 weeks). Cycles were repeated until disease progression or unacceptable toxicity. Stratification factors were prior concomitant chemoradiation (yes/no), histology (squamous cell carcinoma/adenocarcinoma) and platinum agent (cisplatin/carboplatin). Dual primary endpoints were investigator-assessed progression-free survival (PFS) per RECIST v1.1 and overall survival (OS) in the intent-to-treat population. Secondary endpoints included objective response rate (ORR), duration of response (DoR), time to first subsequent therapy (TFST), PFS2 and safety.

Results Between October 2018 and August 2021, 410 patients were randomised. At the data cut-off (median follow-up 32.9 months), median treatment duration was 12.7 vs 8.5 months in the atezolizumab vs standard arms, respectively; treatment was ongoing in 23% vs 7%, respectively. Both PFS and interim OS were statistically significantly improved with the addition of atezolizumab to bevacizumab and chemotherapy; secondary endpoints showed consistent results (figure 1), with ORRs of 84% (95% CI 79–89%) with atezolizumab vs 72% (95% CI 66–78%) with standard therapy. Grade ≥3 adverse events (any cause) occurred in 79% vs 75% of the atezolizumab and standard arms, respectively. Safety profiles were as expected with atezolizumab, bevacizumab and platinum-based chemotherapy.

Conclusion Combining atezolizumab with first-line bevacizumab added to chemotherapy for R/M CC significantly improved all efficacy outcomes. Atezolizumab combined with bevacizumab and platinum-based chemotherapy should be considered a new first-line treatment option for patients with R/M CC.

Disclosures Study drug and funding for this investigator-initiated study are provided by F. Hoffmann-La Roche.

AO reports honoraria/consultation fees from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, Exelisis, EMD Serono, F. Hoffmann-La Roche, Genmab, GSK, ImmunoGen, iTeos Therapeutics, MSD de España, Mersana Therapeutics, Novocure, OncXerna Therapeutics, PharmaMar, Regeneron, Shattuck Labs, Seagen and Sutro Biopharma; travel/accommodation from AstraZeneca, PharmaMar and Roche. Coauthor disclosures are provided separately.

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