James Burke, Chief Medical Officer at KaliVir Immunotherapeutics, shared on LinkedIn:
“Excited to share the publication of BOND-003, a phase 3 study of cretostimogene (AKA CG0070) for the treatment of BCG unresponsive non-muscle invasive bladder cancer (NMIBC).
As published in Lancet Oncology, the primary endpoint of complete response rate (75%) is further supported by a DoR of at least 27.9 mos (not reached as of this publication), low rate of progression to muscle invasive disease (3.6%), and high rate of bladder preservation (81% at 24 mos).
Intravesical administration also proved quite tolerable with the most common adverse events of transient grade 1-2 urinary frequency, urgency, and bladder spasm with no grade 3 or higher adverse events related to cretostimogene.
In total, the study provides the basis for a new standard for care for BCG unresponsive NMIBC and by far the most impressive data for an oncolytic virus to date.
Very grateful to have had the opportunity to lead the clinical program from first in human to pivotal phase 3, registration directed studies.
Congratulations and thanks to our academic partners who believed in the therapeutic potential of this agent (in particular Drs Li, Uchio, Tyson, Lamm and Steinberg who contributed significantly not only to patient enrollment and treatment but intellectually to the design and analysis of the study), the entire team at CG Oncology, and most of all to the patients and their families who entrusted us with their care.
We look forward to final BLA submission in Q4 of this year followed by FDA approval.”
Title: Intravesical cretostimogene grenadenorepvec oncolytic immunotherapy in high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ (BOND-003 Cohort C): a single-arm, phase 3 trial
Authors: Mark D. Tyson II, Jong-Kil Nam, Shreyas S. Joshi, Edward M. Uchio, Seung Il Jung, Trinity J. Bivalacqua, Gary D. Steinberg, Neal D. Shore, James M. Burke, Hiroshi Kitamura, Ben Tran, Roger Li
Read also “BOND-003 Phase 3: Cretostimogene Shows 75% Complete Response Rate in BCG-Unresponsive NMIBC” on OncoDaily.
