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September 14, 2025

Feasibility and safety results from RAD-IO: A multi-stage trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer.

Key Points

Most participants completed chemoradiotherapy as planned, with only minor delays reported in treatment.
In total, 29 participants were randomized, and 86.2% completed radiotherapy without delays, showing feasibility of the treatment schedule.
Toxicity was reported, with 6 serious adverse events in the combination group, but no discontinuations of durvalumab due to toxicity.
The trial indicates that adding durvalumab may be achievable alongside standard chemoradiotherapy for muscle-invasive bladder cancer.

Abstract

778 Background: Immune checkpoint inhibitors have a substantial and growing role in all stages of care for bladder cancer. Durvalumab (Durva) is a humanised monoclonal antibody that inhibits binding of PD-L1. Recent phase 3 results with peri-operative durvalumab show a 25% reduction in the risk of death compared to standard of care. Methods: RADIO is a multi-stage trial comparing standard chemoradiotherapy (CRT) with 5FU 1 (IQR 1-1), MMC; 0.97 (IQR 0.94-0.99), 5FU; 0.8 (IQR 0.49-0.96), Durva; 0.97 (IQR 0.88-1). Toxicity for patients on the CRT + Durva arm, between informed consent and 3 months post the end of CRT:6 SAEs were reported, 3 of which were SARs and 0 were SUSARs. Of these SAEs, 3 were related to trial treatment (2 related to Durva, 2 related to 5FU 0, MMC; 0, 5FU; 2, Durva; 1), and 2 SAEs lead to dose delays (RT; 0, MMC; 0, 5FU; 0, Durva; 2). In the CRT + Durva arm there were 9 AEs grade ≥3 (6 related to trial treatment). Results split by CRT only or CRT + Durva will be available at the time of the conference, and all figures are provisional on subsequent rounds of data cleaning. Conclusions: The schedule of neo-adjuvant, synchronous and adjuvant durvalumab was deliverable with full dose CRT to bladder. Most participants completed CRT as planned, none discontinued Durva due to toxicity, only 3 incurred toxicity related delays but continued treatment. Clinical trial information: 43698103.

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