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

Avelumab first-line maintenance for advanced urothelial carcinoma: analysis of clinical and genomic subgroups from the phase 3 JAVELIN Bladder 100 trial (#235)

Sumit Lumba 1 , Thomas Powles 2 , Daniel P. Petrylak 3 , Se Hoon Park 4 , Srikala S. Sridhar 5 , Claudia Caserta 6 , Antoine Thiery-Vuillemin 7 , Hyo Jin Lee 8 , Joaquim Bellmunt 9 , Yoshiaki Yamamoto 10 , Jeanny B. Aragon-Ching 11 , Bo Huang 12 , Keith A. Ching 13 , Craig Davis 13 , Alessandra di Pietro 14 , Yohann Loriot 15 , Petros Grivas 16
  1. Royal North Shore Hospital, Sydney, Australia
  2. Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom
  3. Yale Cancer Center, New Haven, Connecticut, United States
  4. Sungkyunkwan University Samsung Medical Center, Seoul, South Korea
  5. Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada
  6. Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni, Italy
  7. University Hospital of Besançon, Besançon, France
  8. Chungnam National University School of Medicine, Daejeon, South Korea
  9. Beth Israel Deaconess Medical Center; Harvard Medical School, Boston, Massachusetts, United States
  10. Yamaguchi University Hospital, Ube, Yamaguchi, Japan
  11. Inova Schar Cancer Institute, Fairfax, Virginia, United States
  12. Pfizer, Groton, Connecticut, United States
  13. Pfizer, La Jolla, California, United States
  14. Pfizer srl, Milano, Italy
  15. Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France
  16. University of Washington; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington, United States

Aims: In JAVELIN Bladder 100 (NCT02603432), avelumab first-line maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients with advanced urothelial carcinoma (UC) not progressed with first-line platinum-based chemotherapy (HR, 0.69 [95% CI: 0.56, 0.86; 1-sided P=0.0005]). We report post hoc analyses in clinical and genomic subgroups.

Methods: Patients with unresectable locally advanced or metastatic UC without progression after 4-6 cycles of first-line gemcitabine + carboplatin (GemCar) or gemcitabine + cisplatin were randomized to receive avelumab + BSC (n=350) or BSC alone (n=350). The primary endpoint was OS, assessed in all randomized patients and patients with PD-L1+ tumors (Ventana SP263). This exploratory analysis evaluated OS in subgroups defined by primary tumor or type of advanced disease, in patients with PD-L1+ tumors treated with first-line GemCar, and in genomic subtypes (RNAseq whole-transcriptome profiling of tumor tissue) per The Cancer Genome Atlas (TCGA 2017).

Results: Prolonged OS was observed with avelumab + BSC vs BSC alone (HR [95% CI]) in patients with upper or lower tract tumors (0.89 [0.578, 1.373] and 0.62 [0.477, 0.802]); metastatic or locally advanced and unresectable disease prior to chemotherapy (0.88 [0.678, 1.147] and 0.40 [0.265, 0.617]), or lymph node-only disease post-chemotherapy (0.55 [0.259, 1.152]); and patients with PD-L1+ tumors who had received first-line GemCar (0.67 [0.393, 1.137]). An OS benefit for avelumab + BSC was apparent in TCGA subtypes basal squamous (0.62 [0.326, 1.187]), luminal infiltrated (0.68 [0.481, 0.968]) and luminal papillary (0.63 [0.370, 1.079]) but not luminal (1.01 [0.403, 2.509]).

Conclusions: An OS benefit was seen for avelumab first-line maintenance + BSC vs BSC alone across subgroups of interest. Results are consistent with previously reported findings, further supporting avelumab first-line maintenance as a standard of care for patients with advanced UC that has not progressed with first-line platinum-based chemotherapy.

  1. © 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 ASCO Annual Meeting. All rights reserved.