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Mini Oral - Genitourinary tumours, non-prostate

704MO - Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone with 1L chemotherapy (CTx) for advanced urothelial carcinoma (UC): Subgroup analyses from JAVELIN Bladder 100


18 Sep 2020


Mini Oral - Genitourinary tumours, non-prostate


Cytotoxic Therapy;  Immunotherapy

Tumour Site

Urothelial Cancer


Petros Grivas


Annals of Oncology (2020) 31 (suppl_4): S550-S550. 10.1016/annonc/annonc274


P. Grivas1, S.H. Park2, E. Voog3, C. Caserta4, B. Perez Valderrama5, H. Gurney6, H. Kalofonos7, S. Radulovic8, W. Demey9, A. Ullén10, Y. Loriot11, S.S. Sridhar12, N. Tsuchiya13, E. Kopyltsov14, S. Gupta15, B. Huang16, N. Costa17, J.A. Blake-Haskins18, A. di Pietro19, T.B. Powles20

Author affiliations

  • 1 Department Of Medicine, Division Of Medical Oncology, University of Washington; Fred Hutchinson Cancer Research Center, 98109-4405 - Seattle/US
  • 2 Division Of Hematology-oncology, Department Of Internal Medicine, Sungkyunkwan University Samsung Medical Center, 06351 - Seoul/KR
  • 3 Department Of Medical Oncology, Centre Jean Bernard Clinique Victor Hugo, 72000 - Le Mans/FR
  • 4 Medical Oncology Unit, Azienda Ospedaliera S. Maria, 05100 - Terni/IT
  • 5 Department Of Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 6 Department Of Clinical Medicine, Macquarie University, 2109 - Sydney/AU
  • 7 Medical Oncology, University General Hospital of Patras, 265 04 - Patras/GR
  • 8 Department Of Medical Oncology, Institute for Oncology and Radiology of Serbia, 11000 - Belgrade/RS
  • 9 Department Of Medical Oncology, AZ KLINA, 2930 - Brasschaat/BE
  • 10 Department Of Oncology-pathology, Karolinska University Hospital, Karolinska Institute, 171 77 - Solna/SE
  • 11 Department Of Medical Oncology, Institut Gustave Roussy, INSERMU981, Université of Paris Saclay, 94805 - Villejuif/FR
  • 12 Department Of Medicine, Princess Margaret Cancer Centre, University Health Network, M5G 2M9 - Toronto/CA
  • 13 Department Of Urology, Yamagata University Faculty of Medicine, 990-8560 - Yamagata/JP
  • 14 Department Of Medical Oncology, State Institution of Healthcare Regional Clinical Oncology Dispensary, 644046 - Omsk/RU
  • 15 Department Of Hematology And Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 16 Biostatistics, Pfizer, 06340 - Groton/US
  • 17 Global Oncology, Pfizer, 2740-244 - Lisbon/PT
  • 18 Immuno-oncology, Pfizer, 92121 - La Jolla/US
  • 19 Immuno-oncology, Pfizer SRL, 04100 - Milan/IT
  • 20 Department Of Medical Oncology, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, EC1A 7BE - London/GB


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Abstract 704MO


In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab (anti–PD-L1) 1L maintenance + BSC significantly prolonged overall survival (OS) vs BSC alone in patients (pts) with advanced UC without disease progression with 1L induction CTx (gemcitabine + cisplatin [GemCis] or carboplatin [GemCar]) in all randomized pts (hazard ratio [HR] 0.69; p=0.0005) and pts with PD-L1+ tumors (HR 0.56; p=0.0003). We report prespecified subgroup analyses.


Pts were randomized 1:1 to avelumab + BSC or BSC alone, stratified by best response to 1L CTx (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.


700 pts were randomized to either avelumab + BSC (n=350) or BSC alone (n=350); median follow-up was >19 mo. An OS benefit with avelumab + BSC vs BSC alone (median [95% CI], mo) was observed across prespecified subgroups, including pts with objective response (CR/PR; 23.8 [19.0, not estimable (NE)] vs 15.0 [13.0, 18.7]; HR 0.69 [0.53, 0.89]) or SD (19.9 [18.2, NE] vs 14.0 [10.7, 19.4]; HR 0.70 [0.46, 1.05]) as best response to 1L CTx; and pts with visceral (18.9 [16.5, 21.4] vs 14.0 [11.7, 17.4]; HR 0.82 [0.62, 1.09]) and nonvisceral metastases (28.3 [23.8, NE] vs 15.2 [13.4, 20.2]; HR 0.54 [0.38, 0.76]). OS in other subgroups is shown (Table). No significant treatment-by-subgroup interaction (at 0.05 level) was observed for any subgroup variable. Additional subgroups, progression-free survival, objective response endpoints, and safety data will also be presented.


Avelumab 1L maintenance + BSC provided OS benefit vs BSC alone across prespecified subgroups of pts whose disease had not progressed with 1L induction CTx and is an important advance for 1L treatment of advanced UC. Table: 704MO

Median OS (95% CI), mo HR (95% CI) Interaction p-value*
Avelumab + BSC BSC
1L CTx 0.82
GemCis 25.3 (18.6, NE) 16.5 (13.4, 26.8) 0.69 (0.51, 0.94)
GemCar 19.9 (16.0, 24.0) 12.9 (9.4, 16.2) 0.66 (0.47, 0.91)
ECOG performance status 0.55
0 26.0 (20.1, NE) 17.8 (14.3, 23.7) 0.64 (0.48, 0.86)
≥1 18.2 (13.3, 21.4) 11.6 (9.6, 14.1) 0.74 (0.54, 1.03)
Creatinine clearance 0.97
≥60 mL/min 22.5 (18.2, NE) 14.6 (13.3, 18.7) 0.68 (0.50, 0.92)
<60 mL/min 20.8 (18.8, NE) 13.5 (11.6, 18.6) 0.68 (0.50, 0.94)
PD-L1 status
+ NE (20.3, NE) 17.1 (13.5, 23.7) 0.56 (0.40, 0.78) 0.08
18.8 (13.3, 22.5) 13.7 (10.8, 17.8) 0.86 (0.62, 1.18) 0.68
Unknown 20.1 (10.6, NE) 12.8 (9.6, NE) 0.69 (0.31, 1.53)

*Wald Chi-sq. test, 2 sided.

Clinical trial identification


Editorial acknowledgement

Medical writing support was provided by Kelly Bryant of ClinicalThinking (Hamilton, NJ, USA) and funded by Pfizer and Merck KGaA, Darmstadt, Germany.

Legal entity responsible for the study



This study was sponsored by Pfizer, and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany.


P. Grivas: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (institution): Bavarian Nordic; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Biocept; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses, Educational unbranded activity with Bristol-Myers Squibb (2017): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Clovis Oncology; Research grant/Funding (institution): Debiopharm; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Driver; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: EMD Serono; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Exelixis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Foundation Medicine; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Honoraria (self), Advisory/Consultancy: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Heron Therapeutics; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Mirati Therapeutics; Research grant/Funding (institution): Oncogenex; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution): Immunomedics; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Seattle Genetics; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: QED Therapeutics; Honoraria (institution): KureIT. C. Caserta: Advisory/Consultancy: Janssen; Advisory/Consultancy: Merck; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Novartis Pharma SAS; Advisory/Consultancy: Pfizer Pharmaceuticals Israel. B. Perez Valderrama: Advisory/Consultancy, Non-remunerated activity/ies: Astellas Pharma; Advisory/Consultancy, Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory/Consultancy, Non-remunerated activity/ies: Ipsen; Advisory/Consultancy: Pierr-Fabre; Advisory/Consultancy: Bayer; Advisory/Consultancy, Non-remunerated activity/ies: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: EUSA Pharma; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Novartis Pharma SAS; Non-remunerated activity/ies: Pfizer Pharmaceuticals Israel. H. Gurney: Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Ipsen; Advisory/Consultancy: AstraZeneca. Y. Loriot: Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas. S.S. Sridhar: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Merck; Advisory/Consultancy, Research grant/Funding (institution): Pfizer. N. Tsuchiya: Honoraria (self): Astellas; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Janssen; Honoraria (self): Novartis; Honoraria (self): Ono; Honoraria (self): Bayer; Honoraria (self): Sanofi; Honoraria (self): Takeda; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MDS. S. Gupta: Honoraria (self), Speaker Bureau/Expert testimony: Exelixis; Honoraria (self), Speaker Bureau/Expert testimony: Janssen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy: AstraZeneca; Research grant/Funding (institution): Astellas. B. Huang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer. N. Costa: Full/Part-time employment: Pfizer. J.A. Blake-Haskins: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer. A. di Pietro: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer. T.B. Powles: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech/Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Incyte; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Research to Practice; Honoraria (self), Travel/Accommodation/Expenses: Ferring; Honoraria (self): Gerson Lehrman Group; Honoraria (self): Janssen Research & Development. All other authors have declared no conflicts of interest.

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