CG Oncology (CGON) Study Result summary

Study design and patient population

• BOND-003 is a global, single-arm, phase 3 trial evaluating cretostimogene grenadenorep monotherapy in high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC) patients, including those with carcinoma in-situ, with or without Ta or T1 papillary tumors, following strict FDA criteria.

• The trial enrolled 112 patients, predominantly older white men, with a highly pre-treated population: median 12 BCG treatments, 38% had prior intravesical chemotherapy, and 7% had prior systemic immunotherapy.

• Induction and maintenance treatment mirrored the classic BCG paradigm, with repeat induction allowed for persistent disease.

• All patients had pathologically confirmed high-risk NMIBC; prior intravesical chemotherapy and systemic immunotherapy were allowed.

• Cretostimogene has received FDA Fast Track and Breakthrough Therapy Designations, and enrollment is complete.

Efficacy results

• Complete response (CR) rate at any time was 74.5% (95% CI: 65.4%-82.4%) as of September 30, 2024.

• At 12 months, 46% of patients remained in CR; at 24 months, 41% had confirmed CR.

• Median duration of response (DOR) exceeds 27 months and is ongoing; at 12 and 24 months, 63.5% and 56.6% of responders maintained CR.

• 97.3% of patients were free from progression to muscle-invasive bladder cancer at 12 months; 90% cystectomy-free survival at 12 months.

• 50% of reinduction patients converted to CR, with two-thirds of these responses durable at data cutoff.

Comparative efficacy and durability

• Median DOR exceeds 27 months, surpassing pembrolizumab (16 months) and nadofaragene firadenovec (10 months).

• CR rates were consistent across demographic and clinical subgroups, including high-risk CIS, T1 populations, and those with prior therapies.

• No difference in CR rates between patients with or without prior intervening therapies.

• Sustained responses observed beyond 30 months, with 64.3% of re-induced patients maintaining durable response.

• Demonstrated favorable efficacy and safety compared to other therapies, with 0% grade 3+ treatment-related AEs and no treatment-related discontinuations.