Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2022

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): results from patients with ≥12 months of treatment in JAVELIN Bladder 100 (#228)

Jeanny B. Aragon-Ching 1 , Petros Grivas 2 , Yohann Loriot 3 , Joaquim Bellmunt 4 , David W. Pook 5 , Jing Wang 6 , Elisabete Michelon 7 , Alessandra di Pietro 8 , Thomas Powles 9 , Srikala S. Sridhar 10
  1. Inova Schar Cancer Institute, Fairfax, Virginia, USA
  2. University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington, USA
  3. Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France
  4. Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
  5. Oncology Department, Monash Health, Melbourne, Victoria, Australia
  6. Pfizer, Cambridge, Massachusetts, USA
  7. Pfizer, New York, USA
  8. Pfizer srl, Milano, Italy
  9. Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, UK
  10. Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada

Aims: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), patients with aUC that had not progressed with 1L platinum-based chemotherapy had significantly prolonged overall survival and progression-free survival with avelumab 1L maintenance + best supportive care (BSC) compared with BSC alone. Results led to avelumab 1L maintenance being approved worldwide and adopted into international treatment guidelines as standard of care. Here, we report long-term data from patients with ≥12 months of avelumab 1L maintenance treatment as part of the JAVELIN Bladder 100 trial.

Methods: Eligible patients had unresectable locally advanced or metastatic UC that had not progressed with 1L platinum-based chemotherapy. This analysis included patients randomized to receive avelumab + BSC. Study treatment continued until confirmed progression, unacceptable toxicity, or withdrawal of consent.

Results: After a median follow-up of 38.0 months in the avelumab arm (data cutoff June 4, 2021; ≥2 years in all patients), 118/350 patients (33.7%) had received ≥12 months of treatment. Characteristics of these patients were generally similar to those in the overall avelumab arm. Among all treated patients in the overall avelumab arm (N=344), grade ≥3 treatment-related adverse events (TRAEs) occurred in 67 (19.5%) and grade ≥3 immune-related AEs (irAEs) occurred in 26 (7.6%). Among patients treated for ≥12 months (n=118), grade ≥3 TRAEs occurred after ≥12 months in 14 (11.9%) and grade ≥3 irAEs occurred after ≥12 months in 5 (4.2%). Efficacy outcomes will be presented.

Conclusions: In the JAVELIN Bladder 100 trial, prolonged avelumab 1L maintenance treatment was associated with a safety profile consistent with prior avelumab monotherapy studies, with no new safety signals identified with longer treatment duration. These results further support the use of avelumab 1L maintenance until progression for patients with aUC that has not progressed with 1L platinum-based chemotherapy.

  1. Funding Statement: This trial was sponsored by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945). Medical writing support was provided by Jamie Ratcliffe of ClinicalThinking and was funded by Pfizer and Merck.
  2. Previously presented at ESMO 2022, “FPN: 1760P”, “Jeanny B. Aragon-Ching et al.” - Reused with permission.