Avelumab first-line maintenance (1LM) for advanced urothelial carcinoma (aUC): Long-term patient-reported outcomes (PROs) in the phase 3 JAVELIN Bladder 100 trial.

Authors

null

Petros Grivas

Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA

Petros Grivas , Jeanny B. Aragon-Ching , Joaquim Bellmunt , Yohann Loriot , Srikala S. Sridhar , Po-Jung SU , Se Hoon Park , Yoshiaki Yamamoto , Natalia Jacob , Jason Hoffman , Mairead Kearney , Michael Schlichting , Thomas Powles

Organizations

Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA, Inova Schar Cancer Institute, Fairfax, VA, Beth Israel Deaconess Medical Center; Harvard Medical School, Boston, MA, Institut de Cancérologie Gustave Roussy, Villejuif, France, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, Chang Gung Memorial Hospital, Linkuo, Taiwan, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Yamaguchi University Hospital, Ube, Yamaguchi, Japan, The Healthcare Business of Merck KGaA, Darmstadt, Germany, EMD Serono, Billerica, MA, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, London, United Kingdom

Research Funding

This study was sponsored by Pfizer and was previously conducted under an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) and Pfizer.
This analysis was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany.

Background: In the JAVELIN Bladder 100 trial, avelumab 1LM + best supportive care (BSC) significantly prolonged overall survival vs BSC alone in patients (pts) with aUC that had not progressed with 1L platinum-based induction chemotherapy, and health-related quality of life was maintained. We report long-term and exploratory PRO analyses in the overall avelumab + BSC arm (any treatment duration) and in the subgroup with ≥12 months of avelumab treatment. Methods: In JAVELIN Bladder 100 (NCT02603432), PROs were a secondary endpoint assessed at baseline, on day 1 of each 4-week cycle, at end of treatment/withdrawal, and up to 90 days post treatment. PRO instruments used were National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol 5 Dimensions 5 Levels (EQ-5D-5L). Descriptive and mixed-effect model analyses were conducted. Data were not evaluated in the BSC alone arm because few pts remained on study treatment at later time points. Results: At data cutoff (Jun 4, 2021), median follow-up in the avelumab arm (n=350) was 38.0 months (≥2 years in all pts), and median duration of treatment was 5.8 months. In pts treated for ≥12 months (n=118 [33.7%]), baseline characteristics were similar to those in the overall avelumab + BSC arm, except for a higher proportion with ECOG performance status of 0 (70.3% vs 60.9%) and lower proportion with visceral metastases (47.5% vs 54.6%). In both populations, completion rates for both PRO instruments among evaluable pts were >80% at all time points during treatment. On average, PRO scores remained stable throughout treatment, and no clinically relevant changes from baseline were reported (Table). Among pts treated for ≥12 months, ≈75% of evaluable pts reported no change or a decrease in being bothered by treatment side effects throughout 24 months of treatment. Conclusions: Prolonged avelumab 1LM treatment (≥12 months) was associated with stable PROs, indicating preservation in quality of life. The results further support the use of avelumab 1LM until progression or unacceptable toxicity as standard of care with level 1 evidence in pts with aUC who are progression-free after platinum-based chemotherapy. Clinical trial information: NCT02603432.

Least-squares Mean Change From Baseline (95% CI)
Overall Avelumab + BSC Arm (n=350)Pts with ≥12 Months of Avelumab Treatment (n=118)
FBISI-18 total score−2.15 (−3.25, −1.04)1.28 (0.08, 2.49)
Disease related symptoms–physical−1.39 (−1.88, −0.89)−0.05 (−0.63, 0.52)
Disease related symptoms–emotional0.27 (0.11, 0.44)0.68 (0.46, 0.91)
Treatment side effects−0.42 (−0.73, −0.11)0.22 (−0.16, 0.59)
Function/well-being−0.15 (−0.34, 0.04)0.36 (0.09, 0.62)
EQ-5D-5L index score−0.07 (−0.09, −0.05)−0.02 (−0.04, 0.00)
Visual analog scale−1.14 (−2.95, 0.67)4.16 (2.09, 6.23)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Urothelial Carcinoma

Track

Urothelial Carcinoma

Sub Track

Symptoms, Toxicities, Patient-Reported Outcomes, and Whole-Person Care

Clinical Trial Registration Number

NCT02603432

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 581)

DOI

10.1200/JCO.2024.42.4_suppl.581

Abstract #

581

Poster Bd #

F8

Abstract Disclosures