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A multicentre, international, randomised, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy after first-line platinum-based chemotherapy in patients with advanced urothelial cancer (JAVELIN bladder 100)

Date

09 Oct 2016

Session

Poster display

Presenters

Thomas Powles

Citation

Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373

Authors

T. Powles1, P. Grivas2, J.B. Aragon-Ching3, Y. Faroun4, E.R. Kessler5, Y. Tomita6, D. Chakrabarti7, R.J. Laliberte7, M. Shnaidman7, D. Petrylak8

Author affiliations

  • 1 Medical Oncology, Royal Free Hospital, NW3 2QG - London/GB
  • 2 Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 3 Medical Oncology, Inova Schar Cancer Institute, Fairfax/US
  • 4 Medical Oncology, St. Luke's Hospital & Health Network, Bethlehem/US
  • 5 Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora/US
  • 6 Development Of Urology, Niigata University Graduate School of Medical and Dental Sciences., Niigata/JP
  • 7 Research, Pfizer Inc., New York/US
  • 8 Medical Oncology, Yale Cancer Center, New Haven/US
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Resources

Abstract 596

Background

Although first-line cisplatin-based chemotherapy prolongs survival in advanced urothelial cancer (UC), most patients (pts) progress within 8 months and no standard second-line therapies are currently available. Recent studies with anti-PD-L1 agents in pretreated UC have shown antitumour activity and promising survival compared with historical controls. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody that has shown an acceptable safety profile and clinical activity across a range of tumour types in a large phase 1b study. In an expansion cohort of pts with pretreated UC, treatment with avelumab resulted in a 16% objective response and 59% disease control rate. A phase 3 study (NCT02603432) has been initiated to determine if maintenance therapy with avelumab can prolong the benefit of first-line chemotherapy in pts with advanced UC.

Trial design

JAVELIN Bladder 100 is a phase 3, international, open-label trial of avelumab + best supportive care (BSC) compared with BSC alone administered as maintenance treatment for pts with locally advanced/metastatic UC whose disease did not progress after first-line treatment with 4–6 cycles of gemcitabine + cisplatin or gemcitabine + carboplatin. Other eligibility criteria include measurable disease prior to chemotherapy and adequate hematologic/organ function. Avelumab 10 mg/kg is administered every 2 wks as a 1 hr infusion. An estimated 668 pts will be randomized 1:1 and stratified based on best response to first-line chemotherapy and metastatic site. This trial has 2 co-primary populations: pts with PD-L1–positive tumours and all pts. The primary endpoint is overall survival and secondary endpoints include progression-free survival (PFS), objective response, safety, and symptoms/quality of life. Tumour response and PFS (RECIST v1.1) are assessed by blinded central review. Trial enrolment began in May 2016. *Proposed INN.

Clinical trial identification

NCT02603432

Legal entity responsible for the study

N/A

Funding

Pfizer Inc.

Disclosure

T. Powles: Research Funding: AZ and Roche Honoraria: Novartis, BMS, Merck. P. Grivas: Consulting/Advisory/Honoraria: Genentech, Deudreon, Bayer Speaker Bureau: Genentech. Research Funding: Pfizer, Merck, Oncogenex, Mirati, Roche, Bayer. J.B. Aragon-Ching: Honoraria/Consulting/Advisory: AZ, Algeta/Bayer, Dendreon Speakers Bureau: BMS. Y. Faroun: Honoraria: Celgene Speakers' Bureau: BMS, Celgene Travel/Accommodations/Expenses: Celgene. Y. Tomita: Consulting/Advisory Role: Novartis Research funding: Pfizer, Astellas, AZ. D. Chakrabarti: Employee and stockholder: Pfizer Inc. R.J. Laliberte: Employee: Pfizer Inc, Galena Biopharma, Inc. M. Shnaidman: Employee: Merck KGaA. All other authors have declared no conflicts of interest.

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