Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2022

Long-term outcomes in patients with advanced urothelial carcinoma (UC) who received avelumab first-line (1L) maintenance with or without second-line (2L) treatment: exploratory analyses from JAVELIN Bladder 100 (#227)

Joaquim Bellmunt 1 , Thomas Powles 2 , Miguel A. Climent Duran 3 , Srikala S. Sridhar 4 , Howard Gurney 5 , David W. Pook 6 , Nuno Costa 7 , Alessandra di Pietro 8 , Bo Huang 9 , Shilpa Gupta 10 , Petros Grivas 11
  1. Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
  2. Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, UK
  3. Instituto Valenciano de Oncología, Valencia, Spain
  4. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada
  5. Department of Clinical Medicine, Macquarie University, Sydney, New South Wales, Australia
  6. Oncology Department, Monash Health, Melbourne, Victoria, Australia
  7. Pfizer, Porto Salvo, Portugal
  8. Pfizer srl, Milano, Italy
  9. Pfizer, Groton, Connecticut, USA
  10. Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USA
  11. University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington, USA

Aims: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients with advanced UC that had not progressed with 1L platinum-based chemotherapy. Data on outcomes in patients who receive 2L treatment after avelumab 1L maintenance are limited. We report exploratory analyses of outcomes in patients enrolled in the avelumab + BSC arm of JAVELIN Bladder 100 based on receipt of 2L treatment administered by investigators after discontinuation of study treatment.

Methods: Eligible patients had unresectable locally advanced or metastatic UC without progression with 4-6 cycles of 1L platinum-based chemotherapy. Patients were randomized 1:1 to receive avelumab + BSC or BSC alone.

Results: In the avelumab + BSC arm (n=350), median follow-up (data cutoff, June 4, 2021) was 38.0 months. 185 patients (52.9%) had discontinued avelumab 1L maintenance treatment for any reason and received 2L treatment, whereas 122 (34.9%) had discontinued avelumab and did not receive 2L treatment. Median OS (95% CI) in these subgroups was 19.9 months (18.2-23.0) and 18.2 months (10.0-34.4), respectively. In 43 patients (12.3%) still receiving avelumab, median treatment duration was 154.6 weeks (range, 106.7-216.0). Among patients who received 2L treatment, median time from end of avelumab 1L maintenance to start of 2L treatment was 1.35 months (range, 0.3-30.9) and median time from randomization to end of 2L treatment was 11.7 months (95% CI, 9.7-13.8). 2L treatment comprised rechallenge with platinum-based chemotherapy in 75 patients (21.4%) or other 2L treatment in 110 (31.4%), including 2L anti–PD-(L)1 therapy in 11 (3.1%).

Conclusions: In this exploratory analysis from JAVELIN Bladder 100 with extended follow-up, 185/307 patients (≈60%) who had discontinued avelumab received 2L treatment. Long-term OS was observed in patients who received avelumab 1L maintenance with or without 2L treatment.

  1. 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. © 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved.