e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Avelumab first-line maintenance + best supportive care vs best supportive care alone for advanced urothelial carcinoma not progressed with first-line chemotherapy: prespecified subgroup analyses from JAVELIN Bladder 100 (#234)

Sumit Lumba 1 , Petros Grivas 2 , Se Hoon Park 3 , Eric Voog 4 , Claudia Caserta 5 , Begoña P. Valderrama 6 , Howard Gurney 7 , Haralabos Kalofonos 8 , Sinisa Radulovic 9 , Wim Demey 10 , Anders Ullén 11 , Yohann Loriot 12 , Srikala S. Sridhar 13 , Norihiko Tsuchiya 14 , Evgeny Kopyltsov 15 , Shilpa Gupta 16 , Bo Huang 17 , Nuno Costa 18 , John A. Blake-Haskins 19 , Alessandra di Pietro 20 , Thomas Powles 21
  1. Royal North Shore Hospital, Sydney, Australia
  2. University of Washington; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington, United States
  3. Sungkyunkwan University Samsung Medical Center, Seoul, South Korea
  4. Centre Jean Bernard Clinique Victor Hugo, Le Mans, France
  5. Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni, Italy
  6. Hospital Universitario Virgen del Rocío, Seville, Spain
  7. Macquarie University, Sydney, New South Wales, Australia
  8. Medical Oncology, University General Hospital of Patras, Patras, Greece
  9. Institute for Oncology and Radiology of Serbia, Belgrade, Serbia
  10. AZ KLINA, Brasschaat, Belgium
  11. Genitourinary Oncology Unit, Karolinska University Hospital, Solna, Sweden
  12. Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France
  13. Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada
  14. Yamagata University Faculty of Medicine, Yamagata, Japan
  15. State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia
  16. Cleveland Clinic, Cleveland, Ohio, United States
  17. Pfizer, Groton, Connecticut, United States
  18. Pfizer, Porto Salvo, Portugal
  19. Pfizer, La Jolla, California, United States
  20. Pfizer srl, Milano, Italy
  21. Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom

Aims: In the phase 3 JAVELIN Bladder 100 trial, avelumab first-line maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients with advanced urothelial carcinoma (UC) without disease progression with first-line chemotherapy (gemcitabine + cisplatin [GemCis] or carboplatin [GemCar]). We report prespecified subgroup analyses.


Methods: Patients were randomized 1:1 to avelumab + BSC (n=350) or BSC alone (n=350), stratified by best response to first-line chemotherapy (complete/partial response [CR/PR] vs stable disease [SD]) and by visceral vs nonvisceral disease. The primary endpoint was OS (from randomization). PD-L1 status was assessed using the Ventana SP263 assay.

Results: Median follow-up was >19 months. An OS benefit with avelumab + BSC vs BSC alone (HR [95% CI]) was observed across prespecified subgroups, including patients who received GemCis (0.69 [0.51, 0.94]) or GemCar (0.66 [0.47, 0.91]) as first-line chemotherapy; patients with objective response (CR/PR; 0.69 [0.53, 0.89]) or SD (0.70 [0.46, 1.05]) as best response to first-line chemotherapy; and patients with visceral (0.82 [0.62, 1.09]) and nonvisceral metastases (0.54 [0.38, 0.76]). An OS benefit with avelumab + BSC vs BSC alone (HR [95% CI]) was also seen in patients with ECOG performance status of 0 (0.64 [0.48, 0.86]) or ≥1 (0.74 [0.54, 1.03]); creatinine clearance ≥60 mL/min (0.68 [0.50, 0.92]) or <60 mL/min (0.68 [0.50, 0.94]); and PD-L1+ (0.56 [0.40, 0.78]) or PD-L1− (0.86 [0.62, 1.18]) tumors. No significant treatment-by-subgroup interaction (at 0.05 level) was observed for any subgroup variable. Observations were similar for progression-free survival.

Conclusions: Avelumab first-line maintenance + BSC provided OS benefit vs BSC alone across prespecified subgroups in patients whose disease had not progressed with first-line chemotherapy. These results support avelumab first-line maintenance as standard of care for patients with advanced UC without disease progression with first-line chemotherapy.

  1. Previously presented at ESMO 2020, “FPN:704MO”, “Petros Grivas et al.” - Reused with permission.