Plenary: Next Frontier, Monday

Plenary: Next Frontier

PNFLBA-13: Late-Breaking Abstract - Interim Results from A Single-Arm Multicenter Phase II Trial of CG0070, an Oncolytic Adenovirus, for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (NMIBC)

Monday, May 15
10:55 AM - 11:00 AM
Location: BCEC: Ballroom East

Presentation Authors: Vignesh T. Packiam*, Chicago, IL, Daniel A. Barocas, Nashville, TN, Karim Chamie, Los Angeles, CA, Ronald L. Davis III, Winston-Salem, NC, A. Karim Kader, San Diego, CA, Donald L. Lamm, Phoenix, AZ, Dominic Curran, Alex W. Yeung, Santa Ana, CA, Gary D. Steinberg, Chicago, IL

Introduction: CG0070 is a replication selective oncolytic adenovirus that destroys bladder tumor cells through their defective retinoblastoma pathway. Prior reports have shown promising activity in patients with high-grade NMIBC who previously did not respond to BCG. However, limited accrual has hindered analysis of efficacy, particularly for pathologic subsets. We evaluated interim results of a phase II trial for intravesical CG0070 in patients with BCG-unresponsive NMIBC who refused cystectomy.

Methods: At interim analysis, thirty-six patients with residual high grade Ta, T1, or CIS ± Ta/T1 had 6 month follow-up in this phase II single arm multicenter trial (NCT02365818). All patients received at least 2 prior courses of intravesical therapy for CIS, with at least 1 of them being a course of BCG. Patients had either failed BCG induction therapy within 6 months or had been successfully treated with BCG with subsequent recurrence. Complete response (CR) at 6 months was defined as absence of disease on cytology, cystoscopy, and random biopsies.

Results: Of 36 patients there were 18 CIS, 4 CIS + Ta, 3 CIS + T1, 8 Ta, 3 T1 (Figure 1). Overall 6 month CR was 44%. Considering 6 month CR for pathologic subsets: pure CIS was 72.2%, CIS ± Ta/T1 52%, CIS + Ta/T1 0%, pure Ta/T1 27%. In non-responders with CIS, there were 4 patients (22%) with persistent CIS at 6 months, and 1 (5.6%) that progressed to CIS + T1. No patients with pure T1 or CIS + Ta/T1 had 6-month CR. In patients with both CIS + Ta/T1 (n=7), 5 had persistent Ta/T1 ± CIS, while 2 had CIS on biopsy at 6 months. All treatment related adverse events (AEs) at 6 months were Grade 1-3, most commonly urinary: dysuria (47%), bladder spasms (44%), hematuria (36%), and urgency (33%). Immunologic treatment related AEs included fatigue (11%) and chills (5.6%). Grade 3 treatment related AEs included dysuria (5.6%) and hypotension (2.7%). There were no Grade 4/5 treatment related AEs.

Conclusions: This phase II study demonstrates that intravesical CG0070 yielded an overall 44% complete response rate at 6 months for all patients and 52% for patients with CIS, with an acceptable level of toxicity for patients with high-risk BCG-unresponsive NMIBC. There is a particularly strong response and limited progression in patients with pure CIS.

Source Of Funding: Cold Genesys

Vignesh T. Packiam, MD

University of Chicago

Vignesh Packiam is a fifth year urology resident at the University of Chicago. His clinical interest is urologic oncology, for which he is pursuing fellowship training. His research has included basic science projects and clinical trials focused on bladder cancer immunology. He has also published several clinical studies for prostate, bladder, and renal malignancies utilizing institional and national databases.

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PNFLBA-13: Late-Breaking Abstract - Interim Results from A Single-Arm Multicenter Phase II Trial of CG0070, an Oncolytic Adenovirus, for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (NMIBC)



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