Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2024

AUSTRALI-AVE: design of a retrospective noninterventional study evaluating real-world patient characteristics and treatment patterns with avelumab in locally advanced or metastatic urothelial cancer (la/mUC) and metastatic Merkel cell carcinoma (mMCC) in Australia (#566)

Ben Tran 1 , Tania Moujaber 2 , Niara Oliveira 3 , Mark Shackleton 4 , David Pook 5 , Fanny Franchini 6 7 , Mahsa H. Kouhkamari 8 , Brittany Schoeninger 8 , Alison G Miles 8 , Beilei Wu 8 , Greer Bennett 9 , Annalisa Varrasso 9 , Xiao Liu 9 , Jason Hoffman 10 , Mairead Kearney 11 , Wen Xu 12
  1. Medical Oncology, Sir Peter MacCallum Cancer Centre, VIC, Australia
  2. Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, NSW, Australia
  3. Mater Hospital Brisbane, Mater Misericordiae Ltd, South Brisbane, QLD, Australia
  4. Department of Medical Oncology, Alfred Hospital, Melbourne, VIC, Australia
  5. Department of Oncology, Monash Health, Clayton, VIC, Australia
  6. Centre for Cancer Research and Centre for Health Policy, Faculty of Medicine, Dentistry and Health Sciences, the University of Melbourne, Melbourne, Australia
  7. Melbourne School of Population & Global Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
  8. IQVIA, Sydney, NSW, Australia
  9. Merck Healthcare Pty Ltd, Sydney, NSW, Australia, an affiliate of Merck KGaA
  10. EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA
  11. Merck Healthcare KGaA, Darmstadt, Germany
  12. Princess Alexandra Hospital, Brisbane, QLD, Australia

Background: Real-world data on avelumab treatment for la/mUC and mMCC in Australia are limited. For most patients with la/mUC, platinum-based chemotherapy (PBCT) remains the backbone of first-line (1L) therapy. Avelumab, an anti-PD-L1 immunotherapy, administered as 1L maintenance treatment is the standard of care for patients with la/mUC without disease progression after PBCT. Although MCC is uncommon (<1% of all cutaneous malignancies), it has a high risk of distant spread, and prognosis is poor for patients with mMCC. Avelumab treatment for mMCC is associated with high response rates, durable responses, and favourable long-term overall survival (OS) compared with chemotherapy, and is the only registered immunotherapy for MCC in Australia. Avelumab became available through the Pharmaceutical Benefits Scheme (PBS) for la/mUC in October 2022 and mMCC in May 2019. AUSTRALI-AVE is a national study of patients receiving avelumab and aims to highlight patient demographics and treatment patterns in Australia.

Methods: This is a retrospective, observational study, sourced from the PBS 10% sample dataset using PBS codes during the study period (January 2006 until time of analysis). Index date will be defined as first date of avelumab dispensation for la/mUC or mMCC. Patients will be followed until the end of available data, unless otherwise specified. Primary objectives include characterising patient demographics and describing treatment patterns (including duration, and medication usage pre- and post-avelumab) and OS. Treatment patterns will be analysed using descriptive statistics. Treatment duration and OS will be estimated using Kaplan-Meier analysis. AUSTRALI-AVE will be the first retrospective analysis of avelumab use in Australia and will highlight la/UC and mMCC treatment patterns following PBS listing.