842TiP - A multicentre, international, randomised, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy aft...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Urothelial Cancers
Presenter 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
  • 1Medical Oncology, Royal Free Hospital, NW3 2QG - London/GB
  • 2Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 3Medical Oncology, Inova Schar Cancer Institute, Fairfax/US
  • 4Medical Oncology, St. Luke's Hospital & Health Network, Bethlehem/US
  • 5Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora/US
  • 6Development Of Urology, Niigata University Graduate School of Medical and Dental Sciences., Niigata/JP
  • 7Research, Pfizer Inc., New York/US
  • 8Medical Oncology, Yale Cancer Center, New Haven/US

Abstract

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.