Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): long-term outcomes from the JAVELIN Bladder 100 trial in older patients (#241)

Shilpa Gupta 1 , Miguel A Climent Duran 2 , Srikala S Sridhar 3 , Thomas Powles 4 , Joaquim Bellmunt 5 , Annalisa Varrasso 6 , Karin Tyroller 7 , Silke Guenther 8 , Alessandra di Pietro 9 , Petros Grivas 10
  1. Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
  2. Instituto Valenciano de Oncología, Valencia, Spain
  3. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada
  4. Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, UK
  5. Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
  6. Merck Healthcare Pty Ltd, an affiliate of Merck KGaA, Macquarie Park, NSW, Australia
  7. EMD Serono Research & Development Institute, Inc., an affiliate of Merck KGaA, Billerica, MA, USA
  8. Merck Healthcare KGaA, Darmstadt, Germany
  9. Pfizer srl, Milano, Italy
  10. University of Washington; Fred Hutchinson Cancer Center, Seattle, WA, USA

Aims: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab 1L maintenance therapy + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in patients with aUC without progression following 1L platinum-based chemotherapy (PBC). Avelumab 1L maintenance had a tolerable and manageable safety profile and also had minimal impact on quality of life. Here, we report long-term efficacy and safety outcomes in subgroups based on older age (≥65 years).

Methods: Eligible patients with locally advanced or metastatic UC without progression following 4-6 cycles of 1L PBC were randomized 1:1 to receive avelumab + BSC (n=350) or BSC alone (n=350). For this post hoc analysis, subgroups aged ≥65 to <75 years, ≥75 years, and ≥80 years were analyzed; patients aged <65 years were not included.

Results: At data cutoff (June 4, 2021), median follow-up in both arms was ≥38 months. In the avelumab + BSC and BSC alone arms, age was ≥65 to <75 years in 136 and 163 patients, ≥75 years in 85 and 80 patients, and ≥80 years in 28 and 27 patients, respectively. Across all subgroups, OS and investigator-assessed PFS were prolonged with avelumab + BSC vs BSC alone. HRs (95% CI) for OS were: ≥65 to <75 years, 0.73 (0.543-0.974); ≥75 years, 0.59 (0.401-0.877); and ≥80 years, 0.57 (0.284-1.155). HRs (95% CI) for PFS were: ≥65 to <75 years, 0.51 (0.389-0.666); ≥75 years, 0.38 (0.266-0.554); and ≥80 years, 0.27 (0.129-0.560). Long-term safety of avelumab 1L maintenance was similar across subgroups.

Conclusions: Long-term outcomes from JAVELIN Bladder 100 confirm prolonged OS and PFS with avelumab + BSC vs BSC alone in older patients. These findings provide further support for avelumab 1L maintenance as standard of care in patients with aUC without progression following 1L PBC, including older patients (≥65 years).

  1. Previously presented at ESMO 2023, “FPN: 2215”, “Shilpa Gupta et al.” - Reused with permission.