CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer-Reference-Cited by-同舟云学术

CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer

Published:2024-01-08 Issue: Volume: Page:
ISSN:1479-6694
Container-title:Future Oncology
language:en
Short-container-title:Future Oncology

Author:

Steinberg Gary D¹^ORCID,Shore Neal D²,Redorta Joan Palou³,Galsky Matthew D⁴,Bedke Jens⁵,Ku Ja Hyeon⁶,Kretkowski Michal⁷,Hu Hailong⁸,Penkov Konstantin⁹,Vermette Jennifer J¹⁰,Tarazi Jamal C¹¹,Randall Alison E¹²,Pierce Kristen J¹³,Saltzstein Daniel¹⁴,Powles Thomas B¹⁵

Affiliation:

1. Department of Urology, Rush University Medical Center, Chicago, IL, USA

2. Carolina Urologic Research Center, Grand Strand Urology, 823 82nd Parkway, Myrtle Beach, SC 29572, USA

3. Department of Urology, Fundació Puigvert, Universitat Autònoma de Barcelona, C. de Cartagena 340-350, 08025 Barcelona, Spain

4. The Tisch Cancer Institute, Mount Sinai, 1190 One Gustave L. Levy Place, New York, NY 10029, USA

5. Department of Urology, Eberhard Karls University Tübingen, Geschwister-Scholl-Platz, 72074 Tübingen, Germany

6. Department of Urology, Seoul National University Hospital, 101 Daehak-ro Jongno-gu, Seoul 03080, Republic of Korea

7. Clinical Research Center, Spolka z Ograniczona, Feliksa Nowowiejskiego 5, 61-731 Poznań, Poland

8. Institute of Urology, Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi District, Tianjin 300211, China

9. Private Medical Institution Euromedservice, Suvorovskiy Prospekt, 60, St Petersburg, Russia

10. Pfizer Oncology, Pfizer, 1 Portland Street, Cambridge, MA 02139, USA

11. Pfizer Oncology, Pfizer, 10646 Science Center Drive, San Diego, CA 92121, USA

12. Pfizer Oncology, Pfizer, 235 East 42nd Street, New York, NY 10017 USA

13. Pfizer Oncology, Pfizer, 280 Shennecossett Road, Groton, CT 06340, USA

14. Division of Urology, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA

15. Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London EC1M 5PZ, UK

Abstract

Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants.

Funder

Pfizer

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/fon-2023-0271

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