Ongoing Investigations: Expanding the Role of Cretostimogene in NMIBC Care

EP: 1.Current Standards of Care and Shifting Strategies in NMIBC

EP: 2.NMIBC Treatment Decisions in the Age of BCG Shortages

EP: 3.Expert Discussion on BCG-Unresponsive NMIBC

EP: 4.Bladder-Sparing Breakthroughs: Novel FDA-Approved Treatment Options for NMIBC

EP: 5.Weighing the Risks and Benefits of Bladder-Sparing Agents vs Cystectomy

EP: 6.What’s Next for NMIBC: The Immunotherapy and Gene Therapy Pipeline

EP: 7.Topline Data From the BOND-003 Trial in NMIBC

EP: 8.Immunotherapy in NMIBC: Key Results Safety Profile From BOND-003 Trial

EP: 9.Diving Deeper: Discussing Results From Cohort C in the BOND-003 Trial

Now Viewing

EP: 10.Ongoing Investigations: Expanding the Role of Cretostimogene in NMIBC Care

EP: 11.In the Pipeline: Novel Treatment Delivery Methods for NMIBC

EP: 12.Rethinking First-Line Treatments: Will BCG Continue to Be the Standard in NMIBC?

EP: 13.Optimizing NMIBC Treatment Through Sequencing and Patient Preference

EP: 14.The Growing Call for Combination Therapy in NMIBC Treatment

Ongoing investigations into cretostimogene are expanding across multiple patient populations and therapeutic strategies, building a robust and diverse clinical portfolio. Current studies include trials evaluating cretostimogene as both monotherapy and in combination with other agents. Notably, cohort C in the BOND-3 trial focused on BCG-unresponsive CIS patients, while cohort P, which is still accruing, is studying patients with papillary-only disease. Given that papillary disease tends to respond better than CIS, these results will be key in determining monotherapy efficacy in this subset. Furthermore, the PIVOT-006 trial is investigating cretostimogene in patients with intermediate-risk bladder cancer, a group often managed with observation or chemotherapy, offering the opportunity to assess average treatment effects in this population.

Additional trials, such as CORE-008, are exploring a range of patient backgrounds and treatment combinations. This includes BCG-naive and BCG-exposed cohorts (A and B, respectively), which have completed or are near completion of accrual. Importantly, cohort CX within CORE-008 examines the combination of cretostimogene with intravesical gemcitabine in BCG-unresponsive patients. This randomized arm is evaluating various scheduling regimens to determine whether a synergistic immunotherapy-cytotoxic combination can enhance efficacy while maintaining tolerability. Previous combination work, such as in CORE-001 pairing cretostimogene with pembrolizumab, yielded promising results and remains a potential option for high-risk or treatment-refractory patients.

Excitement also surrounds future combination possibilities and comparative studies. For instance, the PIVOT-006 trial allows crossover from surveillance to active treatment, reflecting real-world patterns and strengthening the relevance of its comparator arm. While combinations like cretostimogene with pembrolizumab may be reserved for select high-risk cases, upcoming data from systemic trials like POTOMAC (BCG and durvalumab) may provide insights into how cretostimogene-based regimens compare across different mechanisms. Altogether, these studies illustrate a broad, data-driven approach to optimizing bladder-preserving therapy for non–muscle-invasive bladder cancer.