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  • O001/#504 Durvalumab, in combination with and following chemoradiotherapy, in locally advanced cervical cancer: results from the phase 3 international, randomized, double-blind, placebo-controlled calla trial

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Oral Abstracts (Regular and Late-Breaking Submission)
Plenary 01: Opening ceremony and oral abstract presentations
O001/#504 Durvalumab, in combination with and following chemoradiotherapy, in locally advanced cervical cancer: results from the phase 3 international, randomized, double-blind, placebo-controlled calla trial
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  1. Bradley Monk1,
  2. Takafumi Toita2,
  3. Xiaohua Wu3,
  4. Juan Carlos Limón4,
  5. Qi Zhou5,
  6. Rafal Tarnawski6,
  7. Masaki Mandai7,
  8. Ronnie Shapira-Frommer8,
  9. Umesh Mahantshetty9,
  10. Maria Del Pilar Estevez-Diz10,
  11. Francisco Ramirez Godinez11,
  12. Szilvia Varga12,
  13. Manuel Humberto Leiva Gálvez13,
  14. Jung-Yun Lee14,
  15. Yulia Kreynina15,
  16. Kathryn Howells16,
  17. Sophie Wildsmith17,
  18. Hannah Dry18,
  19. Ana Nunes19 and
  20. Jyoti Mayadev20
  1. 1University of Arizona, Creighton University, Honorhealth Research Institute, Phoenix, USA
  2. 2Radiation Therapy Center/Chubu Hospital, Radiology, Okinawa, Japan
  3. 3Fudan University Shanghai Cancer Center, Department of Gynecologic Oncology, Shanghai, China
  4. 4Instituto Jalisciense de Cancerología, Department of Medical Oncology, Guadalajara, Mexico
  5. 5Chongqing University Cancer Hospital, Department of Gynecological Oncology, Chongqing, China
  6. 6Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw Branch, Oncology, Gliwice, Poland
  7. 7Kyoto University Graduate School of Medicine, Department of Gynecology and Obstetrics, Kyoto, Japan
  8. 8Chaim Sheba Medical Center, The Ella Institute For Immuno-oncology, Ramat Gan, Israel
  9. 9Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai & Homi Bhabha Cancer Hospital & Research Centre, Radiation Oncology, Visakhapatnam, India
  10. 10Instituto do Cancer do Estado de São Paulo-Faculdade de Medicina da Universidade de São Paulo, Department of Oncology, São Paulo, Brazil
  11. 11Hospital Civil de Guadalajara, Department of Medical Oncology, Guadalajara, Mexico
  12. 12National Institute of Oncology, Radiation Oncology, Budapest, Hungary
  13. 13Instituto Peruano de Oncología y Radioterapia, Medical Oncology, Lima, Peru
  14. 14Institute of Women’s Life Medical Science, Yonsei University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  15. 15Federal State Budgetary Institution RRCRR of the Ministry of Health of the Russian Federation and Sechenov University, Department of Oncology, Radiotherapy and Plastic Surgery, Moscow, Russian Federation
  16. 16AstraZeneca, Statistics, Gaithersburg, USA
  17. 17AstraZeneca, Precision Medicine, R&d Oncology, Cambridge, UK
  18. 18AstraZeneca, Global Development, Waltham, USA
  19. 19AstraZeneca, Global Development, Gaithersburg, USA
  20. 20University of California San Diego Medical Center California, Radiation Medicine, La Jolla, USA

Abstract

Objectives In locally-advanced cervical cancer (LACC), platinum-based chemoradiotherapy (CRT) has been the standard- of-care treatment for >20 years. CALLA is the first global Phase 3 study evaluating immune checkpoint inhibition (durvalumab) versus placebo in combination with and following CRT in LACC (NCT03830866).

Methods Newly-diagnosed, untreated patients with LACC (FIGO 2009 stages IB2-IIB node positive, IIIA-IVA with any node status) were randomized 1:1 to durvalumab (1500 mg IV) or placebo Q4W, for a total of up to 24 months, in combination with and following CRT. CRT comprised concurrent weekly IV cisplatin with EBRT and brachytherapy. RT quality was monitored, with variations evaluated for clinical significance. The primary endpoint is PFS; secondary endpoints include OS, objective response rate, local/distant disease progression incidence, and safety.

Results 770 patients were randomized (N=385 per arm) at 120 sites in 15 countries. Median age was 49 years; median follow-up was 18.5 months. Durvalumab+CRT did not show a statistically significant improvement in PFS vs placebo+CRT (HR 0.84 [95% CI, 0.65–1.08]; P=0.174); there was no detriment to OS, although data were immature and not formally tested. Adverse events of grade 3–4 occurred in 51.7% and 51.0% of patients in the durvalumab+CRT and placebo+CRT arms, respectively; 12.5% and 9.6% of patients discontinued treatment due to AEs possibly related to study drug.

Conclusions Durvalumab in combination with and following CRT did not significantly improve PFS in patients with LACC. Safety of durvalumab+CRT was generally comparable to CRT alone, with no new or unexpected toxicity. Funding: AstraZeneca.

https://doi.org/10.1136/ijgc-2022-igcs.3

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