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Monika Joshi, MD, assistant professor, Penn State Hershey Medical Center, discusses a phase Ib study of durvalumab (Imfinzi) and radiation therapy (DUART) followed by adjuvant durvalumab in patients with urothelial carcinoma.
Monika Joshi, MD, assistant professor, Penn State Hershey Medical Center, discusses a phase Ib study of durvalumab (Imfinzi) and radiation therapy (DUART) followed by adjuvant durvalumab in patients with urothelial carcinoma during the 2018 Genitourinary Cancers Symposium.
There are no existing safety data for the combination of a PD-L1 agent like durvalumab with radiation therapy, Joshi explains. Therefore, this single-arm study aimed to examine the safety signal when combining these 2 modalities. The study will now be expanded to a phase II trial looking at efficacy, with a primary endpoint of median progression-free survival (PFS) and disease control rate.
In the phase Ib portion of the study, presented during the symposium, a total of 6 patients were treated with the combination of durvalumab and radiation therapy on day 1 and day 28 of a 7-week period. Joshi says investigators did not see any clinically significant immune-related adverse events, which was very encouraging.
The majority of patients experienced lymphopenia or thrombocytopenia and non-infective cystitis, but it is fair to conclude that this combination is safe and tolerable, she notes.