PD13-08 CORE1: PHASE 2 SINGLE ARM STUDY OF CG0070 COMBINED WITH PEMBROLIZUMAB IN PATIENTS WITH NON MUSCLE INVASIVE BLADDER CANCER UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG) (2023)

You have accessJournal of UrologyCME1 Apr 2023PD13-08 CORE1: PHASE 2 SINGLE ARM STUDY OF CG0070 COMBINED WITH PEMBROLIZUMAB IN PATIENTS WITH NON MUSCLE INVASIVE BLADDER CANCER UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG) Roger Li, Gary Steinberg, Edward M. Uchio, Donald Lamm, Paras Shah, Ashish M. Kamat, Trinity J Bivalacqua, Vignesh Packiam, Michael J. Chisamore, John Mcadory, Paola Grandi, Nataliya Hnat, and James Burke Roger LiRoger Li More articles by this author , Gary SteinbergGary Steinberg More articles by this author , Edward M. UchioEdward M. Uchio More articles by this author , Donald LammDonald Lamm More articles by this author , Paras ShahParas Shah More articles by this author , Ashish M. KamatAshish M. Kamat More articles by this author , Trinity J BivalacquaTrinity J Bivalacqua More articles by this author , Vignesh PackiamVignesh Packiam More articles by this author , Michael J. ChisamoreMichael J. Chisamore More articles by this author , John McadoryJohn Mcadory More articles by this author , Paola GrandiPaola Grandi More articles by this author , Nataliya HnatNataliya Hnat More articles by this author , and James BurkeJames Burke More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003260.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: CG0070, is an Ad5-based oncolytic vaccine engineered to express GM-CSF and replicate selectively in tumor cells with mutated or deficient RB. The CG0070 mechanism of action includes cell lysis and immunogenic cell death which is enhanced in the presence of GM-CSF. In an open label ph. 2 study, an overall CR rate of 62% and a CR at 12 months (m) of 29% have been observed in patients with high risk NMIBC previously treated with BCG. IV pembrolizumab, was recently approved by the FDA for patients with BCG- unresponsive CIS (with or without papillary tumors) with an overall complete RR of 41% and a 12 m CR rate of ∼20%. This ph. 2 study will assess the potential synergy of the two agents in the treatment of BCG-unresponsive NMIBC. METHODS: 35 pts with BCG-unresponsive CIS with or without concurrent Ta or T1 disease will be treated with intravescical CG0070 (1x1012 vp) in combination with pembrolizumab at a dose of 400 mg IV q6 weeks. CG0070 will be administered weekly x 6 as induction followed by weekly x 3 maintenance instillations at months 3, 6, 9, 12, and 18. Patients with persistent CIS or HG Ta at 3 m may receive re-induction with weekly x 6 of CG0070. Pembrolizumab will be administered up to 24m. Assessment of response will include q3 m cystoscopy with biopsy of areas suspicious for disease, urine cytology, CTU/MRU, and mandatory bladder mapping biopsies at 12 m. Recurrence of HG disease will be enumerated as disease recurrence. The primary endpoint of the study is CR at 12m. Secondary endpoints will include CR at any time, progression free survival, duration of response, cystectomy free survival and the safety. Correlate assessments includes changes in the TME, systemic immune induction, viral replication. RESULTS: Enrollment has been completed. Based on follow up thus far, CR rate of 92% (22/24) at 3 m has been observed. All patients in CR at 3 m remain in CR at downstream timepoints including: 14/16 at 6m, 9/11 at 9m, and 6/8 at 12 m. Treatment related AE are consistent with those observed in studies of each agent alone. CONCLUSIONS: This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference. Source of Funding: CG Oncology © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e408 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Roger Li More articles by this author Gary Steinberg More articles by this author Edward M. Uchio More articles by this author Donald Lamm More articles by this author Paras Shah More articles by this author Ashish M. Kamat More articles by this author Trinity J Bivalacqua More articles by this author Vignesh Packiam More articles by this author Michael J. Chisamore More articles by this author John Mcadory More articles by this author Paola Grandi More articles by this author Nataliya Hnat More articles by this author James Burke More articles by this author Expand All Advertisement PDF downloadLoading ...