Expert Interview
Discussing CG Oncology's CORE-001 Phase 2 Trial of Cretostimogene Combined with Pembrolizumab for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer presented at ASCO 2024
Ticker(s): CGONInstitution: UT Southwestern Medical Center at Dallas
- Professor, Vice Chair of Clinical Affairs, Chief of Urologic Oncology at UT Southwestern Medical Center at Dallas.
- Currently manages 200+ patients with Non-Muscle Invasive Bladder Cancer.
- Published hundreds of research articles and several book chapters on urologic care and procedures, and serves as editorial reviewer for medical periodicals such as the Journal of Urology, European Urology, Cancer, Urologic Oncology, and the British Journal of Urology International.
The CORE-001 trial reported a 54% complete response (CR) rate at 24 months for patients with BCG-unresponsive, high-risk NMIBC. How does this compare with the current FDA-approved therapies and other investigational candidates for this patient population?
Added By: catalin_adminGiven that 95% of patients who achieved a CR at 12 months maintained it for another 12 months, what does this indicate about the durability of the response provided by the cretostimogene and pembrolizumab combination?
The progression-free survival (PFS) rate at 24 months was 100%, with no patients progressing to muscle invasive cancer or metastatic disease. How significant is this outcome for the long-term management and prognosis of high-risk NMIBC patients?
With a median duration of response (DoR) exceeding 21 months, how does the cretostimogene and pembrolizumab combination therapy potentially change the treatment landscape for BCG-unresponsive NMIBC?
Added By: catalin_adminTreatment-related adverse events (TRAEs) were consistent with the individual agents and showed no synergistic toxicity. Can you elaborate on the safety profile of this combination therapy and its implications for patient tolerability?
Considering the 83% CR rate observed at any time during the trial, what does this suggest about the potential of cretostimogene and pembrolizumab in achieving rapid and effective disease control in BCG-unresponsive NMIBC patients?
Cretostimogene and pembrolizumab received FDA Breakthrough Therapy Designation. How might this regulatory status influence the development and potential approval timeline for this combination therapy in treating BCG-unresponsive NMIBC?
What are the next steps in the clinical development of cretostimogene and pembrolizumab, particularly in the planned CORE-008 trial? How will the findings from CORE-001 influence the design and objectives of future clinical trials?
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