SimianX AI LogoSimianX AI

Record mula sa primary source

Decision-gradeTopline na resulta

CG Oncology: Nailathala sa The Lancet Oncology ang topline data ng Phase 3 BOND-003

Ang mga pivotal Phase 3 BOND-003 Cohort C na resulta para sa cretostimogene monotherapy sa high-risk BCG-unresponsive NMIBC na may CIS ay na-publish sa The Lancet Oncology. Natugunan ng trial ang pangunahing endpoint nito na may 75.5% complete response rate at median duration of response na hindi bababa sa 27.9 months. Sinusuportahan ng mga datos na ito ang patuloy na BLA submission at potensyal na FDA approval para sa indikasyong ito.

Mahahalagang fact

Na-file
Hul 27, 2026, 10:45 PM
Kaganapan
Topline na resulta
Direksyon
Positibo
Kumpanya
CGONCG Oncology
Asset
cretostimogene grenadenorepvec
Pinagmulan
Press release ng kumpanya
Kumpiyansa
May source
CR rate
75.5% (95% CI 66.3–83.2)
12mo DOR
64.2% (95% CI 52.2–73.8)
24mo DOR
60.1% (95% CI 48.2–70.0)
median DOR
≥27.9 months
bladder preservation 12mo
89%
bladder preservation 24mo
81%
mibc progression free 48wk
96.6%
mibc progression free 96wk
96.6%

Sipi mula sa source

CG Oncology Announces Publication of Pivotal Phase 3 BOND-003 Cohort C Study Results in The Lancet Oncology DALLAS, July 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced the publication of results from the pivotal Phase 3 BOND-003 Cohort C trial evaluating cretostimogene grenadenorepvec monotherapy in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 disease, in The Lancet Oncology. “Patients with BCG-unresponsive NMIBC often face the difficult decision between pursuing additional bladder-sparing therapies or undergoing a severe, life-altering cystectomy,” said Mark D. Tyson II, M.D., M.P.H., Mayo Clinic, and lead author of the publication. “The re

Press release ng kumpanya

Higit pa tungkol sa asset na ito