Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 16

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 16
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 setting of mUC.

Potential bladder cancer patient populations for our FGFR3 inhibitor

Current 2/3L+ mUC treatment landscape and unmet need

The shift in frontline mUC standard of care from chemotherapy combinations to Padcev in combination with Keytruda has created an unmet need in the post-frontline setting, where Padcev and Keytruda were initially approved as monotherapies. For FGFR3+ mUC patients who have received frontline Padcev and Keytruda, erdafitinib is a second-line treatment option, offering a 35.3% overall response rate (ORR), a median progression free survival (PFS) of 5.6 months and overall survival (OS) of 12.1 months, outperforming single agent chemotherapy. Erdafitinib uptake has been limited by tolerability, including 13% serious treatment-related adverse events (TRAE), 45.9%, grade 3/4 TRAE and 66% TRAE leading to dose reduction.  Other available options include chemotherapy combinations, for which no randomized controlled trial data is available to date. There continues to be a high unmet need for improvements in both efficacy and toxicity in the 2/3L+ setting.  

Current NMIBC treatment landscape and unmet need 

NMIBC is one of the most recurrent of all cancers and current standard of care treatment comes with drawbacks. For low grade lesions, Transurethral Resection of Bladder Tumor (TURBT) with or without adjuvant intravesical chemotherapy is the standard of care, whereas high risk lesions should be treated with either adjuvant BCG or radical cystectomy. TURBT comes with risks and burden to patients, including the need to undergo general anesthesia and potential for adverse events such as bladder perforation. Within the first two years of initial standard of care treatment, intermediate and high risk NMIBC recurrence rates are as high as 40% and 30%, respectively. No novel therapy has been approved for IR NMIBC, with only intravesical therapies remaining in development. For high risk NMIBC, primarily intravesical treatments have been approved only for patients with carcinoma in situ (CIS) and multiple intravesical therapies are in Phase 3 development.

Phase 2 data for erdafitinib in NMIBC suggest the potential for FGFR inhibitors in this indication. Oral erdafitinib demonstrated a preliminary 83% complete response (CR) rate in IR patients presented