No efficacy or safety figures were disclosed ahead of the meeting. CG Oncology signaled that topline data from the BOND-003 papillary-only, BCG-unresponsive cohort and first results from the CORE-008 BCG-naïve CIS cohort will be presented as late-breaking podiums at SUO, alongside posters including 24-month outcomes from a BOND-003 CIS cohort and details of an expanded access program.
The core development is a coordinated data drop designed to position intravesical cretostimogene grenadenorepvec across the NMIBC continuum: high-risk BCG-unresponsive papillary-only disease (BOND-003 Cohort P), high-risk BCG-naïve CIS (CORE-008 Cohort A), and durability in BCG-unresponsive CIS (BOND-003 Cohort C). Trials-in-progress updates on BCG-exposed patients (CORE-008 Cohort B) and an expanded access program round out the agenda. The company’s Phase 3 footprint spans BOND-003 in high-risk BCG-unresponsive NMIBC and PIVOT-006 in intermediate-risk disease, signaling intent to move beyond the CIS-centric evidence base that has defined recent regulatory decisions in this space.
Strategically, the papillary-only readout is the swing factor. While regulators have accepted single-arm designs with complete response endpoints in CIS, papillary-only disease is typically adjudicated on high-grade recurrence-free survival and progression metrics, where evidentiary expectations can be higher and historical controls more contested. A positive, durable papillary signal could unlock a larger addressable population than CIS-focused labels and differentiate cretostimogene from systemic checkpoint therapy and prior intravesical approvals. Conversely, if the data are modest or operationally complex, sponsors and regulators may gravitate toward devices and combinations that are generating momentum in papillary disease. The BCG-naïve data push in CORE-008 is an expansion play: moving earlier in the treatment algorithm where BCG supply variability and tolerability concerns persist, but where regulators typically expect randomized evidence rather than single-arm results.
For urology-led sites, an oncolytic, intravesical regimen fits established workflows for catheter-based instillations but introduces new infection control, handling, and pharmacy SOPs relative to chemotherapeutics or gene therapy. The expanded access program preview suggests CG Oncology is building operational muscle at sites ahead of potential registration, a lesson learned from supply and onboarding frictions that have hampered uptake of other intravesical biologics. CROs and imaging/pathology vendors should expect protocol designs anchored in cystoscopic surveillance and adjudicated HG-RFS, placing premium importance on consistent central review and visit adherence. Sponsors competing in NMIBC will read these datasets against a crowded context that now includes systemic pembrolizumab for BCG-unresponsive CIS, approved intravesical gene therapy, and newer immunostimulatory approaches, with trial conduct increasingly constrained by BCG availability and staffing.
What matters next is magnitude and durability. For papillary-only disease, 12-month high-grade recurrence-free survival and progression-to–muscle-invasive rates will drive regulatory conversations; for CIS, 24-month durability and retreatment patterns will inform value positioning and real-world feasibility. Safety and catheterization tolerability will influence site capacity and patient acceptance. Any signal that cretostimogene can deliver consistent outcomes without adjunctive BCG would be notable in today’s supply environment, but manufacturing scale, cold-chain reliability, and site training will be scrutinized given recent intravesical rollouts. Watch for whether CG Oncology telegraphs a path to registration from BOND-003 subcohorts or holds for full Phase 3 data, how it sequences intermediate-risk development in PIVOT-006, and whether it contemplates combinations to extend depth or breadth of response if monotherapy signals are uneven across subtypes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
