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Poster session 18

1757P - Preliminary results from AVENANCE, an ongoing, noninterventional real-world, ambispective study of avelumab first-line (1L) maintenance treatment in patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC)

Date

10 Sep 2022

Session

Poster session 18

Topics

Tumour Site

Urothelial Cancers

Presenters

Philippe Barthelemy

Citation

Annals of Oncology (2022) 33 (suppl_7): S785-S807. 10.1016/annonc/annonc1080

Authors

P. Barthelemy1, C. Thibault2, E. Voog3, J. Eymard4, A. Ravaud5, A. Flechon6, C. Abraham Jaillon7, W. Hilgers8, S. Le Moulec9, M. Chasseray10, D. Pouessel11, Y.E. Amela12, V. Lorgis13, E. Nicolas14, E. Kazan15, G. Denechere16, M. Solbes17, P. Lambert16, Y. Loriot18

Author affiliations

  • 1 Medical Oncology, Institut de Cancérologie Strasbourg Europe, 67200 - Strasbourg/FR
  • 2 Department Of Medical Oncology, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, AP-HP Centre, Université de Paris Cité, Paris/FR
  • 3 Clinique Victor Hugo, ILC groupe, Le Mans, Cedex/FR
  • 4 Department Of Medical Oncology, Institut de Cancérologie Jean-Godinot, Reims/FR
  • 5 Department Of Medical Oncology, Bordeaux University Hospital, Bordeaux University, Bordeaux/FR
  • 6 Department Of Medical Oncology, Centre Leon Berard, Lyon/FR
  • 7 Service Oncologie Médicale, Foch Hospital, 92150 - Suresnes/FR
  • 8 Department Of Medical Oncology, Avignon-Provence Cancer Institute, Avignon/FR
  • 9 Medical Oncology, Groupe de radiothérapie et d’oncologie des pyrénées, clinique Marzet, Pau/FR
  • 10 Centre Finistérien De Radiothérapie Et D’oncologie, Clinique Pasteur, Brest/FR
  • 11 Department Of Medical Oncology, Institut Claudius Régaud–IUCT Oncopole, Toulouse/FR
  • 12 Centre De Cancérologie Bourgogne, Hôpital privé Le bois, Lille/FR
  • 13 Medical Oncology Icb, Institut de Cancérologie de Bourgogne, Dijon/FR
  • 14 Department Of Medical Oncology, University Hospital of Nimes, Nimes/FR
  • 15 Department Of Medical Oncology, Ramsay Health Group–Private Hospital Villeneuve d'Ascq, Villeneuve-d’Ascq/FR
  • 16 Laboratoire Pfizer, Pfizer Oncology, Paris/FR
  • 17 Laboratoire Merck Santé, Merck Santé SAS, Lyon, France, an affiliate of Merck KGaA, Darmstadt/DE
  • 18 Department Of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif/FR
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Abstract 1757P

Background

In the JAVELIN Bladder 100 trial, patients with la/mUC that had not progressed after 1L platinum-based chemotherapy (CTx) had significantly prolonged overall survival (OS) with avelumab 1L maintenance + best supportive care (BSC) vs BSC only. In the AVENANCE study (NCT04822350), we investigated efficacy and safety in patients with la/muC treated with avelumab 1L maintenance in France.

Methods

In this ongoing study, eligible pts have la/mUC that did not progress after 1L platinum-based CTx and previous, ongoing, or planned avelumab maintenance. The primary endpoint is OS; secondary endpoints include progression-free survival (PFS), duration of treatment (DOT), and safety. Pts who started avelumab ≥6 months prior to data cutoff (January 31, 2022) were analyzed.

Results

The analysis included 267 pts (of 500 planned). Median follow-up was 11.4 months (range, 0-25.0). Median age was 73.1 years (Q1-Q3, 66.7-77.9). At start of 1L CTx (excluding pts with missing data), disease stage was metastatic in 237 pts (90.5%; visceral in 193 [81.8%]) and locally advanced in 25 (9.5%). ECOG performance status was 0-1 in 177 (85.5%) and 2-3 in 30 (14.5%). 1L CTx was gemcitabine + carboplatin in 152 (58.0%), gemcitabine + cisplatin in 82 (31.3%), and other CTx in 28 (10.7%). Median number of cycles was 5 (range, 1-10). Response to 1L CTx was complete response in 56 pts (21.6%), partial response in 144 (55.6%), and stable disease in 52 (20.1%). Median DOT with avelumab was 5.6 months (95% CI, 4.9-7.5). At data cutoff, 100 pts (37.5%) remained on treatment. The 12-month OS rate was 64.1% (95% CI, 57.1%-70.3%) and median PFS from start of avelumab was 5.7 months (95% CI, 5.1-7.9). Treatment-emergent adverse events (AEs) occurred in 142 pts (53.2%) with serious AEs in 58 (21.7%); 59 pts (22.1%) had an AE leading to treatment discontinuation.

Conclusions

These first real-world data for avelumab 1L maintenance in pts with la/mUC from AVENANCE support the findings of the JAVELIN Bladder 100 trial, and confirm the clinical activity and safety of avelumab in a heterogenous population.

Clinical trial identification

NCT04822350.

Editorial acknowledgement

Editorial support was provided by Abhijith Thippeswamy of ClinicalThinking, and was funded by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).

Legal entity responsible for the study

This study was sponsored by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).

Funding

This study was sponsored by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).

Disclosure

P. Barthelemy: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Pfizer, Ipsen, Bayer, Janssen Cilag, Astellas, Novartis, Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen. C. Thibault: Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi; Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, BMS, Pfizer, Merck, Ipsen; Financial Interests, Personal, Speaker’s Bureau: Sanofi, AstraZeneca, Janssen, Astellas, MSD, BMS, IPSEN. J. Eymard: Financial Interests, Personal and Institutional, Research Grant: Pfizer, Ipsen, BMS; Financial Interests, Personal, Advisory Role: Astellas, Sanofi, Janssen, Ipsen. A. Ravaud: Financial Interests, Institutional, Research Grant: Pfizer, Merck, Ipsen; Financial Interests, Personal, Advisory Role: Pfizer, Merck, Ipsen, BMS, AstraZeneca, Eisai; Financial Interests, Personal, Other, Travelling et housing for meetings: Pfizer, Merck, Ipsen, BMS, AstraZeneca, Eisai. A. Flechon: Financial Interests, Personal, Other, Transportation: Merck, Pfizer, MSD, Gilead, Janssen. D. Pouessel: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Merck, MSD, Astellas; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Pfizer, MSD, BMS, Astellas, Janssen, Ipsen; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Pfizer, Merck. E. Nicolas: Financial Interests, Institutional, Advisory Role: Merck. G. Denechere: Financial Interests, Personal, Full or part-time Employment: Pfizer. M. Solbes: Financial Interests, Personal, Full or part-time Employment: Merck Santé SAS, Lyon, France, an affiliate of Merck KGaA. P. Lambert: Financial Interests, Personal, Full or part-time Employment: Pfizer. Y. Loriot: Financial Interests, Personal, Advisory Board: Merck Kga, Pfizer, Gilead, Seattle Genetics, Tahio; Financial Interests, Personal, Other, lectures, Advisory Boards: MSD, AstraZeneca, Astellas, Janssen; Financial Interests, Personal, Other, Lectures, Advisory Boards: Roche, BMS; Financial Interests, Institutional, Research Grant: Janssen, Sanofi, MSD, Roche, Celsius; Financial Interests, Institutional, Invited Speaker: Janssen, Pfizer, Janssen, MSD, Janssen, Exelexis, AstraZeneca, Pfizer, Merck Kga, BMS, Astellas, Gilead, INCYTE; Financial Interests, Invited Speaker: MSD, Astellas, Gilead/Immunomedics, Tahio; Financial Interests, Personal, Invited Speaker: Basilea; Non-Financial Interests, Member: ESMO, ASCO, AACR; Non-Financial Interests, Other, Scientific Committee: ARC. All other authors have declared no conflicts of interest.

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