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E-Poster Display

745P - Patient-reported outcomes (PROs) from JAVELIN Bladder 100: Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma (UC)

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Thomas Powles

Citation

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

Authors

T.B. Powles1, E. Kopyltsov2, P. Su3, F.X. Parnis4, S.H. Park5, Y. Yamamoto6, P.C. Fong7, C. Tournigand8, M.A. Climent Duran9, A. Bamias10, C. Caserta11, J. Chang12, E. Yan13, A. di Pietro14, J. Wang15, P. Grivas16

Author affiliations

  • 1 Department Of Medical Oncology, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, EC1A 7BE - London/GB
  • 2 Department Of Medical Oncology, State Institution of Healthcare Regional Clinical Oncology Dispensary, 644046 - Omsk/RU
  • 3 Department Of Oncology, Chang Gung Memorial Hospital, 33305 - LinKuo/TW
  • 4 Department Of Medical Oncology, Adelaide Cancer Centre, University of Adelaide, 5037 - Adelaide/AU
  • 5 Division Of Hematology-oncology, Department Of Internal Medicine, Sungkyunkwan University Samsung Medical Center, 06351 - Seoul/KR
  • 6 Department Of Urology, Yamaguchi University Hospital, 755-8505 - Ube/JP
  • 7 Department Of Medical Oncology, The University of Auckland and Auckland City Hospital, 1010 - Auckland/NZ
  • 8 Department Of Medical Oncology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Paris-Est Créteil University, 94010 - Créteil/FR
  • 9 Department Of Medical Oncology, Instituto Valenciano de Oncología, 46009 - Valencia/ES
  • 10 Department Of Internal Medicine, Alexandra General Hospital, National and Kapodistrian University of Athens, School of Medicine, 11528 - Athens/GR
  • 11 Medical Oncology Unit, Azienda Ospedaliera S. Maria, 05100 - Terni/IT
  • 12 Global Heor, Pfizer, 10017 - New York/US
  • 13 Biostatistics, Pfizer, 92121 - La Jolla/US
  • 14 Immuno-oncology, Pfizer SRL, 04100 - Milan/IT
  • 15 Biostatistics, Pfizer, 02139 - Cambridge/US
  • 16 Department Of Medicine, Division Of Medical Oncology, University of Washington; Fred Hutchinson Cancer Research Center, 98109-4405 - Seattle/US
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Resources

Abstract 745P

Background

In the phase III JAVELIN Bladder 100 trial (NCT02603432), avelumab (anti–PD-L1) 1L maintenance + BSC significantly prolonged overall survival (primary endpoint) vs BSC alone in patients (pts) with advanced UC without disease progression with 1L induction chemotherapy. Here we report PRO findings.

Methods

In JAVELIN Bladder 100, PROs were a secondary endpoint. Pts were assessed at baseline, on day 1 of each 4-week cycle, at the end of treatment/withdrawal visit, and at short-term follow-up visits (up to 90 days post treatment). Two PRO instruments were employed: National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy Bladder Cancer Symptom Index-18 (FBlSI-18) and EuroQol 5 Dimensions 5 Levels (EQ-5D-5L). Descriptive, mixed-model, and time-to-deterioration (TTD; ≥3-point decrease from baseline in the FBlSI disease-related symptoms–physical subscale for 2 consecutive assessments using the Kaplan-Meier method) analyses were conducted in both primary populations: all randomized pts and pts with PD-L1+ tumors.

Results

Among all randomized pts in the avelumab + BSC (n=350) and BSC alone (n=350) arms, completion rates for both PRO instruments were >90% for the majority of the treatment period. Results from the descriptive analysis and mixed models over the treatment period in FBlSI-18 and EQ-5D-5L were similar between arms. The hazard ratio for TTD was 1.26 (95% CI, 0.90, 1.77; 1-sided p=0.91); median TTD was not reached (95% CI, 13.9 months, not estimable) with avelumab + BSC and was 13.8 months (95% CI, 12.9 months, not estimable) with BSC alone. However, the TTD results should be interpreted with caution given that death and progression were not included in the event definition, and starting from cycle 2 substantially fewer patients were eligible to complete PROs with BSC alone (n=155) than with avelumab + BSC (n=206). PRO results were consistent in the PD-L1+ population.

Conclusions

Adding avelumab 1L maintenance therapy to BSC in pts with advanced UC whose disease had not progressed with 1L platinum-based chemotherapy had no detrimental effect on clinically relevant PROs.

Clinical trial identification

NCT02603432.

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

Pfizer.

Funding

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

Disclosure

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 Gropu; Honoraria (self): Janssen Research & Development. F.X. Parnis: Travel/Accommodation/Expenses: Astellas. P.C. Fong: Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: MSD. C. Tournigand: Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Non-remunerated activity/ies: BMS; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Non-remunerated activity/ies: Sanofi; Advisory/Consultancy, Non-remunerated activity/ies: Novartis; Advisory/Consultancy, Research grant/Funding (institution): Amgen. M.A. Climent Duran: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony: EUSA; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen. A. Bamias: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Pfizer. C. Caserta: Advisory/Consultancy: Janssen; Advisory/Consultancy: Merck; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Novartis Pharma SAS; Advisory/Consultancy: Pfizer Pharmaceuticals Israel. J. Chang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer; Shareholder/Stockholder/Stock options: Bayer Healthcare; Shareholder/Stockholder/Stock options: BMS Co. E. Yan: Full/Part-time employment: Pfizer. A. di Pietro: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer. J. Wang: Full/Part-time employment: Pfizer. P. Grivas: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Biocept; Research grant/Funding (institution): Bavarian Nordic; 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; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Driver; Research grant/Funding (institution): Debiopharm; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: EMD Serono; Honoraria (self), Honoraria (institution), 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, Travel/Accommodation/Expenses: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Heron Therapeutics; Research grant/Funding (institution): Immunomedics; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Genzyme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Mirati Therapeutics; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution): Oncogenex; 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. All other authors have declared no conflicts of interest.

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