Tyra Biosciences Reports Initial Phase 2 SURF302 Results Supporting the First Potential Oral Innovation in LG IR NMIBC with Dabogratinib
Tyra Biosciences reported initial Phase 2 SURF302 results for oral dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer, with a 79% ORR and 64% best-overall-response complete response rate at 60 mg once daily in combined single and multiple marker lesion patients (n=14). In the single marker lesion subgroup that best mirrors the planned adjuvant Phase 3 setting, 60 mg QD delivered a 100% ORR (8/8) and 75% CR as best overall response, while Grade 3 treatment-related AEs occurred in only 4.5% of the 44 safety-evaluable patients with none at the 60 mg dose.
Key figures
- Drug Name
- dabogratinib
- Phase Of Trial
- Phase 2
- Data cutoff
- August 31, 2026
- Planned next cohort
- 70 mg QD (ablative setting)
- Orr 50mg qd combined
- 67% (8/12)
- Orr 60mg qd combined
- 79% (11/14)
- Surf303 first patient
- 3-month complete response with 60 mg QD (LG UTUC)
- Cr 60mg qd combined bor
- 64% (9/14)
- Orr 60mg qd single lesion
- 100% (8/8)
- Orr above auc2500 threshold
- 86% (12/14)
- Orr below auc2500 threshold
- 58% (7/12)
- Cr 60mg qd single lesion bor
- 75% (6/8)
- Grade3 treatment related ae rate
- 4.5% (2/44)
AI analysis
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