Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

SPADE: Design of a real-world observational study of avelumab first-line maintenance (1LM) in advanced urothelial carcinoma (UC) in the Asia-Pacific (APAC) region (#517)

Po-Jun Su 1 , Se Hoon Park 2 , Yu Chieh Tsai 3 , Miso Kim 4 , Wen-Jen Wu 5 , Seasea Gao 6 , Annalisa Varrasso 7 , Sang Joon Shin 8
  1. Chang Gung Memorial Hospital, Linkou Branch, Taiwan, Taoyuan City
  2. Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea, Seoul
  3. National Taiwan University Hospital, Taipei, Taiwan
  4. Seoul National University Hospital, Seoul, South Korea
  5. Kaohsiung Medical University Hospital, Taiwan, Kaohsiung
  6. Merck Pte. Ltd., an affiliate of Merck KGaA, Singapore
  7. Merck Healthcare Pty. Ltd., Macquarie Park, Australia, an affiliate of Merck KGaA, Sydney
  8. Yonsei Cancer Center, Yonsei University Health System, South Korea, Seoul

Introduction and objectives: UC is a common cancer, with >200,000 new cases reported in 2020 in the APAC region. In the global Phase III JAVELIN Bladder 100 trial, avelumab 1LM + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) versus BSC alone in patients with advanced UC who had not progressed with 1L platinum-containing chemotherapy (median OS, 23.8 vs 15.0 months [p=0.0036]; median PFS, 5.5 vs 2.1 months [p<0.0001]), leading to regulatory approvals worldwide, and incorporation into international treatment guidelines with Level 1 evidence. Here, we describe the design of SPADE, an ongoing, real-world, non-interventional study of avelumab 1LM in patients with advanced UC in the APAC region.

Methods: SPADE is a multicenter, prospective, observational study ongoing in Australia, Hong Kong, India, Malaysia, Republic of Korea, Singapore, and Taiwan. Overall, 286 patients with unresectable locally advanced or metastatic (stage IV) measurable UC of any histology that has not progressed with 1L platinum-containing chemotherapy, for whom avelumab 1LM therapy is planned per local clinical practice, will be enrolled. All patients will receive avelumab 800 mg intravenously every 2 weeks (or per local marketing authorization) and will be followed up for 12 months or until avelumab discontinuation. Data collected will include patient demographics, treatment details for 1L platinum-based chemotherapy (regimen, cycles, and response per RECIST), treatment details for avelumab 1LM, and treatment outcomes with avelumab 1LM (6- and 12-month OS and health-related quality of life [HRQoL]). OS will be analyzed using the Kaplan–Meier method. HRQoL will be measured using the EQ-5D-5L and National Comprehensive Cancer Network® (NCCN®)/FACT FBISI-18 questionnaires. An interim analysis is planned after ~30% of patients have been enrolled.

©2023 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Genitourinary Cancers Symposium. All rights reserved.