CG0070 + Keytruda = Many many treatments It's because they keep treating and treating and treating ...
"Competition" awareness ….
Check out the number of treatments and imagine the cost of this combo. It also requires and oncologist, on top of a urologist! It's sure that we won't jv with Merck and we will be very appealing to a Merck's competitor.
Gene Therapy (CG0070) and Keytruda in BCG-Unresponsive CIS-Containing Population: Updated Results, Efficacy, and Correlative Studies - Roger Li
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.
But they have higher toxicity than our treatment and way more treatments (see at the bottom of this email).
Dr. Kamat mentions that this will most probably be approved by the FDA.
So our treatment will also then, given its absence of toxicity, way less number of treatments, similar efficacy and much less costly than their CG0070/Keytruda combo.
AUA interview with Dr. Kamat:
https://www.urotoday.com/video-lectures/aua-2023/video/3383-gene-therapy-and-pembrolizumab-in-bcg-unresponsive-cis-containing-population-updated-results-efficacy-and-correlative-studies-roger-li.html
Here’s their 2023 AUA data:
https://www.businesswire.com/news/home/20230501005139/en/CG-Oncology-Announces-New-Phase-2-Data-with-Cretostimogene-Grenadenorepvec-CG0070-in-Combination-with-KEYTRUDA®-pembrolizumab-in-BCG-Unresponsive-NMIBC
Link to their clinical trial record:
Detailed Description:
An opened label trial designed to evaluate CG0070 and DDM in combination with Keytruda in patients with NMIBC who have failed prior BCG therapy.
The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled.
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.