955 CORE1: phase 2, single arm study of CG0070 combined with pembrolizumab in patients with non muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guerin (BCG)

• DOI: 10.1136/jitc-2021-sitc2021.955
• Publication Date: 2021-11-09T15:41:11Z
• Authors: Roger Li; Gary Steinberg; Donald Lamm; Ed Uchio; Vignesh Packiam; Ashish Kamat; Michael Chisamore; John McAdory; Paola Grandi; Jee-Hyun Kim; James Burke
• Keywords: 0301 basic medicine; 03 medical and health sciences; Neoplasms. Tumors. Oncology. Including cancer and carcinogens; RC254-282; 3. Good health

<h3>Background</h3> CG0070, an oncolytic vaccine available as intravesical therapy, is a serotype 5 adenovirus engineered to express GM-CSF and replicate in tumor cells with mutated or deficient RB (which results increased of the transcription factor E2F). The CG0070 mechanism action includes direct cell lysis conjunction immunogenic death which enhanced presence GM-CSF. In initial phase 1 study well subsequent 2 study, overall CR rate ~62% at 12 months (m) 29% have been observed patients high risk NMIBC previously treated BCG. Intravenous Pembrolizumab was recently approved by FDA for BCG-unresponsive CIS (with without papillary tumors) complete RR 41% 12m ~20%. This (NCT04387461) will assess potential synergy two agents treatment NMIBC. <h3>Methods</h3> 35 concurrent Ta T1 disease be (IVE) dose 1x10e12 vp combination pembrolizumab 400 mg IV q6 weeks. administered weekly x 6 induction followed 3 maintenance instillations 3, 6, 9, 12, 18m. Patients persistent HG m may receive re-induction CG0070. up 24m. Assessment response include q 3m cystoscopy biopsy, urine cytology, CTU/MRU, mandatory bladder mapping biopsies 12m. <h3>Results</h3> primary endpoint m. Secondary endpoints any time, progression free survival, duration response, cystectomy survival safety combination. Correlate assessments changes TME, systemic immune induction, viral replication transgene expression. Baseline expression PD-L1, coxsackie receptor, E2F anti-adenovirus antibody titer correlated response. At this time first demonstrates 100% CR. Treatment related AE limited transient grade 1-2 urinary frequency (3 patients) spasm, hematuria, painful urination, thyroiditis, flu-like symptoms (one patient/each). No 4, SAE were observed. <h3>Conclusions</h3> currently enrolling. Preliminary efficacy data on 8 November 2021 <h3>Trial Registration</h3> NCT04387461 <h3>Ethics Approval</h3> IRB: CG2003C