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Bladder Cancer with FGFR Alterations: THOR-2 Cohort 1 Study at ESMO 2023


An examination of data presented at ESMO 2023 from cohort 1 of the THOR-2 study of high-risk non–muscle invasive bladder cancer (HR NMIBC) with FGFR alterations.

This is a video synopsis/summary of a panel discussion involving Sia Daneshmand, MD.

Daneshmand discusses results from the THOR-2 study of erdafitinib for BCG-refractory non–muscle invasive bladder cancer with FGFR (fibroblast growth factor receptor) alterations. Patients were randomly assigned 2:1 to receive oral erdafitinib 6 mg daily or investigator’s choice of intravesical chemotherapy. The primary end point was recurrence-free survival (RFS), with secondary end points of 6-month and 12-month RFS.

With median 13-month follow-up, median RFS was not reached with erdafitinib versus 0.28 for chemotherapy, favoring erdafitinib. The 12-month RFS was 77% with erdafitinib versus 41% with chemotherapy. Erdafitinib significantly reduced recurrence in high-risk patients. However, most patients experienced treatment-related adverse events with the oral formulation.

Daneshmand notes that while erdafitinib showed efficacy, the oral toxicity profile is concerning for non–muscle invasive bladder cancer treatment. This paved the way for the TAR-200 study using an intravesical formulation of erdafitinib, which will be discussed later.

Video synopsis is AI-generated and reviewed by AJMCÒ editorial staff.

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