CG Oncology's Bladder Cancer Drug Impresses Investors - Here's Why

CG Oncology, Inc. (NASDAQ:CGON) announced on Saturday that cretostimogene grenadenorepvec monotherapy data were presented at the 2025 American Urological Association Annual Meeting.

The Phase 3 BOND-003 Cohort C study is in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease.

The study reported 75.5% complete response (CR) at any time, with 34 confirmed CRs at 24 months and nine patients pending their 24-month assessment as of the March 14, 2025, cutoff date.

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The 12—and 24-month CR rates are 50.7% and 42.3%, respectively, by K-M estimation.

The median duration of response (DOR) is 28 months and ongoing. Notably, 97.3% of patients were free from progression to muscle-invasive disease at 24 months.

Additionally, Cohort P, in patients with BCG-unresponsive Ta/T1 disease without CIS, showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months in 24 treated patients.

A well-tolerated safety profile was observed, consistent with the data in Cohort C.

110 highly pretreated patients are efficacy evaluable in the BOND-003 Cohort C study. No Grade 3 or greater treatment-related adverse events (TRAEs) or deaths were reported.

Patients who experienced TRAEs of any grade had a median resolution time of one day.

No treatment-related discontinuation of cretostimogene was observed. 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance.

In December 2024, CG Oncology revealed topline data from the Phase 3 BOND-003 trial in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG).

The trial demonstrated that 74.5% of patients (82 out of 110) achieved a complete response (CR) at any time after receiving treatment with cretostimogene as a single agent.

The median duration of response (DOR) has not been reached but exceeds 27 months as of the data cutoff of September 30.

Price Action: CGON stock is up 39.9% at $31.30 at the last check Monday.

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