Dr Daneshmand on the Investigation of Erdafitinib in NMIBC With FGFR2/3 Alterations

Siamak Daneshmand, MD, professor of Urology with Clinical Scholar designation, director, Clinical Research, fellowship director, Urologic Oncology, the University of Southern California, discusses the rationale for investigating erdafitinib (Balversa) in patients with recurrent, intermediate-risk non–muscle invasive bladder cancer (NMIBC) harboring FGFR3 or FGFR2 alterations.

Erdafitinib, a selective pan-FGFR TKI, is being evaluated in the multicohort phase 2 THOR-2 trial (NCT04172675). Data from an interim analysis of cohort 3 presented at the 2023 Genitourinary Cancers Symposium showed that at a median follow-up of 5.7 months from first erdafitinib dose, responses were observed in 7 of 10 evaluable patients responded, including 6 who achieved a complete response and 1 who had a partial response.

THOR-2 is an ongoing study with 3 cohorts, including cohort 3, which consists of patients at an intermediate risk with recurrent, low-grade tumors. Oral erdafitinib is a different approach to most other studies in patients with high-risk NMIBC, and the agent was approved by the FDA in April 2019 for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy.

FGFR3 and FGFR2 alterations are strong targets in NMIBC, and with the response rates observed with erdafitinib for patients with metastatic disease, moving these drugs into the early-stage disease setting could beneficial, Daneshmand says. However, investigators are still learning what the response rate is in the early-stage disease, and more research with further follow-up is needed, Daneshmand concludes.