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Trial result

Avelumab + Docetaxel Scores 52% ORR in Platinum-Refractory or -Ineligible mUrothelial Carcinoma

Trial ID
NCT03575013 on ClinicalTrials.gov
Cancer type
Urothelial Carcinoma
Published in
New in Oncology - June 6, 2025

In the single-arm Phase 1b AVETAX trial (NCT03575013), 21 patients with metastatic urothelial carcinoma who were either platinum-refractory (n=8) or cisplatin-ineligible (n=13) received docetaxel plus avelumab, followed by bi-weekly avelumab maintenance. Investigator-assessed objective response rate was 52% (95% CI 30–74); median PFS and OS were 14.6 months and 16.6 months, respectively. There was one dose-limiting toxicity (grade 3 febrile neutropenia).

Take home

If larger studies replicate these double-digit survival figures with manageable myelosuppression, docetaxel-plus-avelumab could fill a chemo-immunotherapy niche for patients who fail—or cannot take—platinum regimens in advanced bladder cancer. However, in comparison with enfortumab vedotin plus pembrolizumab, the preferred first-line regimen for cisplatin-ineligible patients, with ORR 67.7%, median PFS 12.5 months, and median OS 31.5 months, it would appear that docetaxel-plus-avelumab won’t be more effective though perhaps better tolerated since enfortumab vedotin plus pembrolizumab has a discontinuation rate occurring in about 35% of patients, most often due to skin toxicity or neuropathy.

Source: Read the original publication

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