RE:RE:RE:RE:RE:Preliminary Results from BCG-Unresponsive NMIBC Treatment ‘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.
Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years.’
No expert but am reading this as saying that in the first year this Trial used a minimum of 15 and up to 18 instillations of CG0070 and at least 17 intravenous administrations of Keytruda? If so that is a lot of visits.
| Key Exclusion Criteria: - Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
- Prior treatment with adenovirus-based cancer therapy
- Prior therapy with or intolerant to prior checkpoint inhibitor therapy
- Clinically significant or active cardiac disease
- Active autoimmune disease
|
So also a decent-sized patient population (me included!) for which this would not be appropriate.