Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): "Real World" Experience.

Platinum-based chemotherapy (PBC) followed by avelumab switch maintenance in nonprogressors is standard first line (1L) treatment for advanced urothelial carcinoma (aUC). We describe clinical features and outcomes in a "real-world' cohort treated with avelumab maintenance for aUC.

This was a retrospective cohort study of patients (pts) who received 1L switch maintenance avelumab after no progression on PBC for aUC. We calculated progression-free survival (PFS) and overall survival (OS) from initiation of maintenance avelumab. We also described OS and PFS for specific subsets using Cox regression and observed response rate (ORR).

A total of 108 pts with aUC from 14 sites treated with maintenance avelumab were included. There was a median of 6 weeks1-30 from end of PBC to avelumab initiation; median follow-up time from avelumab initiation was 8.8 months (1-42.7). Median [m]PFS was 9.6 months (95%CI 7.5-12.1) and estimated 1-year OS was 72.5%. CR/PR (vs. SD) to 1L PBC (HR = 0.33, 95% CI 0.13-0.87) and ECOG PS 0 (vs. ≥1), (HR = 0.15, 95% CI 0.05-0.47) were associated with longer OS. The presence of liver metastases was associated with shorter PFS (HR = 2.32, 95% CI 1.17-4.59). ORR with avelumab maintenance was 28.7% (complete response 17.6%, partial response 11.1%), 29.6% stable disease, 26.9% progressive disease as best response (14.8% best response unknown).

Results seem relatively consistent with findings from JAVELIN Bladder100 trial and recent "real world" studies. Prior response to platinum-based chemotherapy, ECOG PS 0, and absence of liver metastases were favorable prognostic factors. Limitations include the retrospective design, lack of randomization and central scan review, and possible selection/confounding biases.

Clinical genitourinary cancer. 2023 Jun 20 [Epub ahead of print]

Dimitra Rafailia Bakaloudi, Rafee Talukder, Genevieve Ihsiu Lin, Dimitrios Makrakis, Leonidas N Diamantopoulos, Nishita Tripathi, Neeraj Agarwal, Roubini Zakopoulou, Aristotelis Bamias, Jason R Brown, David J Pinato, James Korolewicz, Tanya Jindal, Vadim S Koshkin, Jure Murgić, Marija Miletić, Ana Frobe, Jeffrey Johnson, Yousef Zakharia, Alexandra Drakaki, Alejo Rodriguez-Vida, Macarena Rey-Cárdenas, Daniel Castellano, Lucia Alonso Buznego, Ignacio Duran, Clara Castro Carballeira, Rafael Morales Barrera, David Marmorejo, Rana R McKay, Tyler Stewart, Shilpa Gupta, Andrew Thomas Ruplin, Evan Y Yu, Ali R Khaki, Petros Grivas

Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA., Department of Epidemiology, University of Washington, Seattle, WA., Department of Medicine, Jacobi Medical Center-Albert Einstein College of Medicine, Bronx, NY., Department of Medicine, University of Pittsburgh, Pittsburgh, PA., Division of Oncology, Department of Medicine, University of Utah, Salt Lake City, UT., 2nd Propaedeutic Department of Internal Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., Division of Oncology, University Hospitals Seidman Cancer Center, Clevelant, OH., Department of Surgery and Cancer, Imperial College London, Hammersmith Campus, London, UK; Division of Oncology, Department of Translational Medicine (DIMET), University of Piemonte Orientale, Novara, Italy., Department of Surgery and Cancer, Imperial College London, Hammersmith Campus, London, UK., Division of Hematology/Oncology, Department of Medicine, Helen Diller Family Cancer Center, University of California San Francisco, San Francisco, CA., Department of Oncology and Nuclear Medicine, University Hospital Center Sestre Milosrdnice, School of Dental Medicine, Zagreb, Croatia., Department of Oncology and Nuclear Medicine, Faculty of Dentistry, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia., Division of Oncology, Department of Medicine, University of Iowa, Iowa City, IA., Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA., Medical Oncology Department, Hospital del Mar, IMM Research Institute, Barcelona, Spain., Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Department of Oncology, University Hospital Marqués of Valdecilla, IDIVAL Santander, Cantabria, Spain., Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Vall d' Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Moores Cancer Center, University of California San Diego, La Jolla, CA., Department of Hematology and Oncology, Taussig cancer Institute, Cleveland Clinic Foundation, Cleveland, OH., Department of Pharmacy, Fred Hutchinson Cancer Center, Seattle, WA., Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA., Division of Oncology, Department of Medicine, Stanford University, Palo Alto, CA. Electronic address: alikhaki@stanford.edu., Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA. Electronic address: pgrivas@uw.edu.

Read an Expert Commentary by Bishoy Faltas, MD