Updated results from AVENANCE: Real-world effectiveness of avelumab first-line maintenance (1LM) in patients (pts) with advanced urothelial carcinoma (aUC) and analysis of subsequent treatment.

Authors

null

Philippe Barthelemy

Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg, France

Philippe Barthelemy , Yohann Loriot , Constance Thibault , Marine Gross-Goupil , Jean Christophe Eymard , Eric Voog , Christine Abraham Jaillon , Sylvestre Le Moulec , Matthieu Chasseray , Aurélien Gobert , Benjamin Auberger , Caroline Viala , Mathilde Cabart , Eyad Kazan , Veronique Lorgis , Werner Hilgers , Constant Josse , Prisca Lambert , Marie-Noelle Solbes , Aude Flechon

Organizations

Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg, France, Institut de Cancérologie Gustave Roussy, Villejuif, France, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, AP-HP Centre, Université de Paris Cité, Paris, France, Bordeaux University Hospital, Bordeaux, France, Institut de Cancérologie Jean-Godinot, Reims, France, ILC Groupe/Clinique Victor Hugo, Le Mans, France, Foch Hospital, Service d’Oncologie Médicale, Suresnes, France, Groupe de Radiothérapie et d’Oncologie des Pyrénées, Clinique Marzet, Pau, France, Centre Finistérien de Radiothérapie et d’Oncologie–Clinique Pasteur, Brest, France, St Gregoire Hospital, St Gregoire, France, CHRU Brest, Institut de Cancérologie et Hematologie (ICH) Hôpital, Morvan, France, CHU de Nantes, Nantes, France, Institut Bergonié, Bordeaux, France, Department of Medical Oncology, Ramsay Health Group–Clinique de la Louvière, Lille, France, Institut de Cancérologie de Bourgogne, Dijon, France, Avignon-Provence Cancer Institute, Avignon, France, eXYSTAT, Malakoff, France, Pfizer Oncology, Paris, France, Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA, Lyon, France, Centre Léon Bérard, Lyon, France

Research Funding

No funding sources reported

Background: Avelumab 1LM is the standard of care for aUC that has not progressed with 1L platinum-based chemotherapy based on level 1 evidence from the JAVELIN Bladder 100 phase 3 trial. Previous results from AVENANCE showed the effectiveness and safety of avelumab 1LM in a real-world population with aUC in France. We report updated data and analyses by subsequent (next-line) treatment. Methods: AVENANCE (NCT04822350) is a noninterventional, ambispective study. Eligible pts had aUC that had not progressed with 1L platinum-based chemotherapy and previous, ongoing, or planned avelumab 1LM treatment. The primary endpoint is overall survival (OS). Data reported are preliminary, and analysis is ongoing. Results: 594 pts were analyzed. At data cutoff (May 31, 2023), median follow-up was 24.2 mo (range, 0.6-43.7); 142 pts (23.9%) remained on avelumab. Median duration of avelumab treatment was 5.6 mo (95% CI, 4.9-6.9). Reasons for discontinuation were disease progression in 330 (73.2%), adverse event in 50 (11.1%), death in 42 (9.3%), and other reasons in 29 (6.4%) pts. 314 pts (52.9%) received subsequent treatment after avelumab: chemotherapy in 238 (75.8%), antibody-drug conjugate (ADC) in 52 (16.6%; enfortumab vedotin, 46 [14.6%]; other, 6 [1.9%]), immunotherapy in 12 (3.8%), and other in 12 (3.8%). Characteristics of pts who received ADC or chemotherapy are shown (Table). In the overall population, median OS from start of avelumab 1LM was 21.1 mo (95% CI, 17.3-23.8), and 1- and 2-y OS rates (95% CI) were 66.58% (62.57%-70.26%) and 45.41% (40.89%-49.82%), respectively. In pts who received subsequent ADC or chemotherapy, median OS (95% CI) from start of avelumab 1LM was 31.3 mo (22.2-not estimable) and 14.0 mo (13.2-15.6), 1-y OS rates (95% CI) were 85.93% (72.72%-93.04%) and 61.68% (55.13%-67.56%), and 2-y OS rates were 66.90% (49.85%-79.29%) and 25.43% (19.17%-32.14%), respectively. Conclusions: Updated results from the AVENANCE study confirm the effectiveness of avelumab 1LM in a real-world population. In pts with subsequent treatment (≈70% of pts who discontinued), a contemporary sequence of ADC after 1L platinum-based chemotherapy and avelumab 1LM treatment showed encouraging OS. Clinical trial information: NCT04822350.

Subsequent Treatment
ADC (n=52)Chemotherapy (n=238)
Age, median, y72.672.9
ECOG performance status, %
 0
1
≥2
23.8
61.9
14.3
28.9
52.2
18.9
Primary tumor site, %
 Lower tract
Upper tract
78.8
21.2
79.3
20.7
Prior treatment for localized UC, %
 28.834.6
Disease stage, %
 Metastatic
Locally advanced
96.2
3.8
94.9
5.1
1L chemotherapy, %
 Carboplatin + gemcitabine
Cisplatin + gemcitabine
ddMVAC
Other or switched
61.5
28.8
3.8
5.8
63.8
23.4
5.1
7.7
Response to 1L chemotherapy, %
 Complete response
Partial response
Stable disease
Other
21.2
53.8
19.2
5.8
17.5
57.3
23.5
1.7

ddMVAC, dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin.

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Urothelial Carcinoma

Track

Urothelial Carcinoma

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Clinical Trial Registration Number

NCT04822350

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 561)

DOI

10.1200/JCO.2024.42.4_suppl.561

Abstract #

561

Poster Bd #

E10

Abstract Disclosures