Tom Jayram, MD, highlights phase 2 trial of FGFR3 inhibitor in LG-IR-NMIBC

The phase 2 SURF302 trial (NCT06995677) is assessing the safety and efficacy of TYRA-300, a FGFR3-selective inhibitor for patients with FGFR3-altered low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).¹

Tom Jayram, MD, recently sat down with Urology Times® to discuss the potential advantages of a FGFR3-selective inhibitor compared with pan-FGFR inhibitors in this patient population. He also outlined the key end points being assessed in the phase 2 trial of the agent, emphasizing the importance of early complete responses. Jayram is a urologist with Urology Associates in Nashville, Tennessee.

Jayram began the discussion by outlining the rationale for a selective FGFR inhibitor.

“This [is a] new concept of drilling down on a selective FGFR inhibitor, where you try to mitigate some of those off-target toxicities—keep the efficacy—but really improve the side effect or tolerability profile,” Jayram explained.

In total, the trial plans to enroll 90 patients with LG-IR-NMIBC. TYRA-300 is being assessed across 3 different dose levels. The primary end point is 3-month complete response rate. Secondary end points include duration of response, recurrence-free survival, progression-free survival, time to recurrence, and safety and tolerability.

Jayram noted, “We know that early recurrence is associated with multiple recurrences, with progression to high-grade disease, and some bad outcomes in the intermediate-risk group. So, if we can prove that early on in the disease course, we're not seeing those recurrences and we're not seeing progression, we feel pretty good that that's a surrogate for longer-term end points.”

REFERENCE

1. Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302). ClinicalTrials.gov. Last updated December 23, 2025. Accessed January 8, 2026. https://clinicaltrials.gov/study/NCT06995677