RE:CG0070 + Keytruda = Many many treatments So if this, below, is gonna be approved by the FDA, as per Dr. Kamat, then there is not a single seed of doubt that our only 2 doses treatment that delivers similar efficacy will be too.
Experimental: Single Arm
CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline.
CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will receive 3 weekly treatments.
Beginning at Week 24, patients will receive weekly x 3 treatments every 3 months through Week 48 then every 24 weeks thereafter.
Keytruda will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years.
85% (n=29/34) of Evaluable Patients Achieved Complete Response at the Initial 3-Month Timepoint from the Phase 2 Clinical Trial
68% (n=17/25) at the 12-month assessment.