Full analysis from AVENANCE: A real-world study of avelumab first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC).

Authors

null

Philippe Barthelemy

Institut de Cancérologie Strasbourg Europe, Strasbourg, France

Philippe Barthelemy , Yohann Loriot , Eric Voog , Jean Christophe Eymard , Alain Ravaud , Aude Flechon , Christine Abraham Jaillon , Matthieu Chasseray , Veronique Lorgis , Werner Hilgers , AurElien Gobert , Sylvestre Le Moulec , Camille Simon , Emanuel Nicolas , Anne Escande , Damien Pouessel , Constant Josse , Marie-Noelle Solbes , Prisca Lambert , Constance Thibault

Organizations

Institut de Cancérologie Strasbourg Europe, Strasbourg, France, Gustave Roussy, Villejuif, France, Clinique Victor Hugo Centre Jean Bernard, Le Mans, France, Institut de Cancérologie Jean-Godinot, Reims, France, Bordeaux University Hospital, Bordeaux University, Bordeaux, France, Centre Léon Bérard, Lyon, France, Foch Hospital, Suresnes, France, Centre Finistérien de Radiothérapie et d’Oncologie–Clinique Pasteur, Brest, France, Institut de Cancérologie de Bourgogne, Dijon, France, Avignon-Provence Cancer Institute, Avignon, France, St Gregoire Hospital, St Gregoire, France, Clinique Marzet, Pau, France, Institut De Cancerologie De Lorraine, Vandœuvre-Lès-Nancy, France, University Hospital of Nimes, Nimes, France, Clinique Ste Anne, Strasbourg, France, Institut Claudius Régaud–IUCT Oncopole, Toulouse, France, eXYSTAT, Malakoff, France, Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA, Darmstadt, Germany, Pfizer Oncology, Paris, France, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, AP-HP Centre, Université de Paris Cité, Paris, France

Research Funding

Pharmaceutical/Biotech Company
This study was sponsored by Pfizer as part of an alliance between Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945)

Background: In the phase 3 JAVELIN Bladder 100 trial, avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in pts with aUC that had not progressed with 1L platinum-based chemotherapy (CTx). The JAVELIN Bladder regimen is now standard of care with level 1 evidence in international treatment guidelines. The AVENANCE study (NCT04822350), is investigating the efficacy and safety of avelumab 1L maintenance in a real-world population of pts with aUC in France. Data from the full analysis set are reported for the first time. Methods: In this ongoing, noninterventional, ambispective study, eligible pts have locally advanced or metastatic UC that has not progressed with 1L platinum-based CTx and previous, ongoing, or planned avelumab 1L maintenance treatment. The primary endpoint is OS from start of avelumab; secondary endpoints include progression-free survival (PFS), duration of treatment (DOT), and safety. Results: 591 pts received avelumab. At data cutoff (July 31, 2022), median follow-up was 12.0 mo (95% CI, 10.9-12.9). Median age was 73.1 y (IQR, 67.0-78.1). At start of 1L CTx (excluding pts with missing data), disease stage was metastatic in 524 pts (90.5%; visceral metastases in 426 [81.5%]) and locally advanced in 54 (9.3%). ECOG PS was 0-1 in 407 pts (85.3%) and 2-3 in 69 (14.5%). Tumor histology was pure UC in 528 pts (91.8%) and UC with variant or pure variant in 47 (8.2%). 1L CTx was gemcitabine + carboplatin (GemCarbo), gemcitabine + cisplatin (GemCis), dose-dense methotrexate + vinblastine + adriamycin + cisplatin (DD-MVAC), and other in 353 (61.0%), 170 (29.4%), 28 (4.8%), and 28 (4.8%) pts, respectively. Median number of cycles was 5 (range, 1-10). Median DOT with avelumab was 5.8 mo (95% CI, 5.2-7.0); 241 pts (40.8%) remained on treatment at data cutoff. The most common reasons for treatment discontinuation were disease progression (74.1% [n=258]), death (11.5% [n=40]), and adverse events ([AEs] 10.3% [n=36]). Median OS from start of avelumab was 18.4 mo (95% CI, 15.4-not estimable [NE]), the 12-month OS rate was 64.8% (95% CI, 60.0%-69.1%), and median PFS was 5.7 mo (95% CI, 5.3-7.0). In pts who had received GemCarbo, GemCis, or DD-MVAC, median OS (95% CI) was 16.2 mo (13.4-NE), not reached (NR; 18.1-NE), and NR (15.2-NE), respectively. Subgroups analyses will be presented. 218 pts received subsequent 2L, including CTx, antibody-drug conjugates, immunotherapy, and other in 186 (85.3%), 22 (10.1%), 6 (2.8%), and 4 (1.8%) pts, respectively. Any-grade treatment-related AEs (TRAEs) occurred in 217 pts (36.7%), including serious TRAEs in 29 (4.9%). Conclusions: Real-world data for avelumab 1L maintenance in pts with aUC from AVENANCE support the findings of JAVELIN Bladder 100 and confirm the clinical activity and acceptable safety profile of avelumab in a heterogeneous population. Clinical trial information: NCT04822350.

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Track

Urothelial Carcinoma,Prostate Cancer - Advanced

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Clinical Trial Registration Number

NCT04822350

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 471)

DOI

10.1200/JCO.2023.41.6_suppl.471

Abstract #

471

Poster Bd #

H12

Abstract Disclosures