Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

Real-world data from early access and patient access programs of avelumab first-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma in Australia (#240)

Tania Moujaber 1 , Ben Tran 2 , Elizabeth Liow 3 , Timothy Clay 4 , Annalisa Varrasso 5 , Greer Bennett 5 , Mairead Kearney 6 , Alison Gibberd 7 , Howard Gurney 8
  1. The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead , NSW, Australia
  2. Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
  3. Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia
  4. Bendat Family Comprehensive Cancer Centre, St John of God Subiaco Hospital, Subiaco, Western Australia
  5. Merck Healthcare Pty Ltd, an affiliate of Merck KGaA, Macquarie Park, NSW, Australia
  6. Merck Healthcare KGaA, Darmstadt, Germany
  7. Hunter Medical Research Institute, Newcastle, NSW, Australia
  8. Macquarie University and Westmead Hospital, Sydney, NSW, Australia

Aims: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab first-line maintenance (1LM) + best supportive care (BSC) significantly prolonged overall survival vs BSC alone in patients with advanced urothelial carcinoma (aUC) that had not progressed after 1L platinum-based chemotherapy (PBC). Avelumab 1LM is now recommended as standard of care in international guidelines with level 1 evidence. We report real-world data from early access and patient access programs (EA/PAPs) of avelumab 1LM therapy in patients with aUC in Australia.

Methods: Data were collected from Australian EA/PAPs from February 2021 to September 2022, before the reimbursement of avelumab in Australia (October 2022). Patients eligible for data collection had aUC, were progression-free following 1L PBC, and had received ≥1 avelumab dose. Avelumab treatment duration was estimated by the Kaplan-Meier method.

Results: 295 patients (median age, 73.9 years [interquartile range, 67.0-78.5]) received avelumab; the majority were male (79%) and from New South Wales (34%) or Victoria (27%). Most patients had received carboplatin and/or cisplatin + gemcitabine (94%), and the median number of 1L PBC cycles was 4. For 164 patients with available data, the median treatment-free interval (date from end of 1L PBC to avelumab initiation) was 35 days (interquartile range, 28-49). At the time of analysis, 123 of 295 patients (42%) had discontinued avelumab, most commonly due to progressive disease (66%) and adverse events (15%). Of 264 patients with available data, an estimated 35.1% (95% CI, 27.1-43.1) remained on avelumab after 1 year. The estimated median time on avelumab treatment was 37 weeks (95% CI, 31-42).

Conclusions: These real-world data provide insights about how avelumab 1LM, which is the standard-of-care treatment for patients with aUC whose disease has not progressed with 1L PBC, is being incorporated into treatment practice in Australia.

Previously presented at ANZUP 2023, “FNP: 47”, “Tania Moujaber et al.” - Reused with permission.