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Mini oral session - Genitourinary tumours, non-prostate

659MO - Avelumab (A) as the basis of neoadjuvant chemotherapy (NAC) regimen in platinum eligible and ineligible patients (pts) with non-metastatic muscle invasive bladder cancer (NM-MIBC)


18 Sep 2021


Mini oral session - Genitourinary tumours, non-prostate


Tumour Site

Urothelial Cancer


Nieves Martinez Chanza


Annals of Oncology (2021) 32 (suppl_5): S678-S724. 10.1016/annonc/annonc675


N. Martinez Chanza1, A. Carnot2, P. Barthelemy3, V. Casert4, B. Sautois5, J. Van den Brande6, V. Vanhaudenarde7, L. Staudacher8, E. Seront9, S. Culine10, M. Gizzi11, T. Gil1, M. Paesmans12, N. Kotecki1, M. Ignatiadis1, S. Albisinni13, J.C. Fantoni14, T. Tricard15, T. Roumeguere13, A.H. Awada1

Author affiliations

  • 1 Medical Oncology, Jules Bordet Institute, 1000 - Brussels/BE
  • 2 Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 3 Medical Oncology Department, ICANS - Institut de Cancérologie Strasbourg Europe, 67200 - Strasbourg/FR
  • 4 Department Of Oncology, Hospital Ambroise Pare, 7000 - Mons/BE
  • 5 Department Of Medical Oncology, Centre Hospitalier Universitaire Sart Tilman, 4000 - Liège/BE
  • 6 Medical Oncology, University Hospital Antwerp, Antwerp/BE
  • 7 Medical Oncology, CHU-UCL-Namur - Site Sainte-Elisabeth, 5000 - Namur/BE
  • 8 Medical Oncology Department, Hopital St. Joseph, 75014 - Paris/FR
  • 9 Medical Oncology Department, Centre Hospitalier Jolimont-Lobbes, 7100 - Haine-Saint-Paul/BE
  • 10 Medical Oncology, Hôpital Saint Louis, 75010 - Paris/FR
  • 11 Medical Oncology Dept, GHdC - Grand Hopital de Charleroi - Site Notre Dame, 6000 - Charleroi/BE
  • 12 Data Center, Institut Jules Bordet, 1000 - Brussels/BE
  • 13 Urology, Erasme University Hospital-(Universite Libre de Bruxelles), 1070 - Brussels/BE
  • 14 Urology, Centre Oscar Lambret, Lille/FR
  • 15 Urology Department, Nouvel Hôpital Civil - Hôpitaux Universitaire de Strasbourg, Strasbourg/FR


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Abstract 659MO


Cisplatin-based NAC is considered as standard of care for NM-MIBC pts based on a modest survival benefit correlated with pathological complete response (pCR). Avelumab, a monoclonal antibody directed against PD-L1, showed efficacy in advanced urothelial cancer. We report preliminary data from the AURA trial assessing preoperative avelumab associated with two cisplatin-based regimens in the cisplatin eligible cohort.


AURA is a prospective, multicenter, randomized, phase II trial for pts with cT2-4aN0-2M0 bladder carcinoma. Cisplatin-eligible pts received cisplatin-gemcitabine (CG) plus A or dose-dense MVAC (DD-MVAC) plus A (1:1). Primary endpoint was pCR (ypT0/isN0) with the objective, in each arm, to show pCR rate > 25% (90% power reached in case of pCR rate > 45%). Two-step design was used with planned interim analysis after 28 evaluable pts per arm. Secondary endpoints were pathologic downstaging rate (


At interim analysis data cut-off, 56 cisplatin-eligible pts were evaluable. For CG + A arm (n=28): median age was 69 years (41-81), 64% male, 7% cT4 and 7% cN+. For DD-MVAC + A arm (n=28): median age was 62 years (51-77), 79% male, 7% cT4 and 7% cN+. Six pts did not undergo surgery but were included in intention to treat analysis. Efficacy outcomes according to treatment regimen are represented in the table. Most common grade 3/4 AEs were thrombocytopenia (29%), acute kidney injury (18%) neutropenia (14%), and anemia (13%). No patients required steroids for immune-related AEs. No treatment-related deaths were reported. The IDMC recommended stopping accrual in this cohort because the endpoint was reached. Table: 659MO

CG + A N = 28 DD-MVAC + A N = 28
pCR 50% 54%
57% 64%
Median weeks from randomization to surgery 15.7 11.5


Interim results from the AURA phase II trial demonstrate a high pCR rate with neoadjuvant avelumab in combination with each cisplatin-based NAC regimen. Further results in cisplatin eligible/ineligible cohorts and correlative studies will be presented.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

CTSU - Jules Bordet Institute.


Merck N.V.-S.A., Belgium, an affiliate of Merck KGaA, Darmstadt, Germany, as part of an alliance between Merck KGaA and Pfizer.


All authors have declared no conflicts of interest.

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