Dr. Grivas on the Real-World Study of Avelumab Maintenance in Metastatic Urothelial Carcinoma

Petros Grivas, MD, PhD, physician, Fred Hutchinson Cancer Center, associate professor, Division of Medical Oncology, University of Washington (UW) School of Medicine, clinical director, Genitourinary Cancers Program, UW Medicine, associate professor, Clinical Research Division, Fred Hutchinson Cancer Research Center, discusses key baseline characteristics from the real-world PATRIOT II study of first-line avelumab (Bavencio) maintenance therapy in metastatic urothelial cancer (mUC). 

The ongoing, retrospective study of maintenance avelumab stemmed from results of the phase 3 JAVELIN Bladder 100 trial (NCT02603432), which showed that avelumab maintenance plus best supportive care elicited significant overall survival and progression-free survival benefits vs best supportive care alone in patients with locally advanced or metastatic urothelial cancer who did not progress on first-line platinum-based chemotherapy.

To investigate real-world treatment patterns and patient characteristics for those receiving avelumab maintenance, PATRIOT-II collected data from 37 geographically dispersed oncology practices/communities and academic centers in the United States, Grivas begins. The study retrospectively enrolled select patients who went on to receive avelumab maintenance, and those who progressed during first-line chemotherapy were excluded from the study. Of the 160 patients included in the study thus far, 31% had upper tract disease, 49% had lower tract disease, 3% had upper and lower tract disease, and 18% had an unknown site of primary tumor.

The median duration of chemotherapy administration was 13 weeks, and the median number of chemotherapy cycles was 5. Thirteen percent of patients experienced a complete response to chemotherapy, and 68% had a partial response. The remaining patients exhibited stable disease (11%) or had unknown response status (8%). The median time to first imaging after chemotherapy initiation was 10 weeks, which was consistent with clinical practice, Grivas says. Moreover, 14% were hospitalized while receiving chemotherapy, and 16% went to the emergency department.

These baseline characteristics were generally consistent with therapy paradigms in the frontline induction setting, as a similar proportion of patients in the general population would have medical comorbidities, Grivas explains. Patients proceeded to first-line avelumab maintenance at a median of 4 weeks following the completion of chemotherapy, which was a shorter duration compared with patients from JAVELIN Bladder 100, Grivas concludes.

Future analyses from PATRIOT II will further examine treatment patters and clinical outcomes for avelumab maintenance.

Editor’s Note: Dr Grivas reports serving as a consultant or in an advisory role for 4D Pharma, Aadi Bioscience, Asieris, Astellas Pharma, AstraZeneca, BostonGene, Bristol Myers Squibb, CG Oncology, Dyania Health, Exelixis, Fresenius Kabi, G1 Therapeutics, Genentech, Gilead Sciences, Guardant Health, ImmunityBio, Infinity Pharmaceuticals, Janssen, Lucence, Mirati Therapeutics, MSD, Pfizer, PureTech, Regeneron, Roche, Seattle Genetics, Silverback Therapeutics, Strata Oncology, QED Therapeutics, Merck KGaA, and UroGen Pharma; he reports institutional research funding from Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm Group, G1 Therapeutics, Gilead Sciences, GlaxoSmithKline, Mirati Therapeutics, MSD, Pfizer, QED Therapeutics, and Merck KGaA.