Opinion
Video
Author(s):
"The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib," says Gopa Iyer, MD.
In this video, Gopa Iyer, MD, shares the background and preliminary findings from the phase 1/2 SURF301 (NCT05544552) trial of TYRA-300 in advanced/metastatic urothelial carcinoma. Iyer is a genitourinary medical oncologist, an early drug development specialist, and the section head of bladder cancer at Memorial Sloan Kettering Cancer Center in New York, New York.
Video Transcript:
SURF301 is a phase 1 study of a novel FGFR3 inhibitor, TYRA-300. It's an exciting drug. Similar to LOXO-435, it’s an FGFR3 isoform-specific inhibitor, and it really spares inhibition of FGFR1, 2 and 4. The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib. The most common side effect was diarrhea. It was low-grade in most patients. There was 1 patient who had grade 3 diarrhea. This was a DLT. But other than that, as well as some increased transaminitis, the drug is extremely well tolerated. In that study, they found that the objective response rate at 90 mg daily was about 50%. They also increased the dose level to 120 mg daily and have seen response in a patient at that level as well. So, [this is] another very exciting drug that's continuing dose escalation to try to identify the best dose for further development.
This transcript was AI generated and edited by human editors for clarity.
REFERENCE
1. Tran B, Zhang A, Hansen A, et al. Preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301). Presented at: 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. October 23-25, 2024. Barcelona, Spain. Abstract 500LBA