Hi Guys
The below is a summary of where the data sits currently. I guess my take is we continued to be excited around the combination of CAVATEK plus check point inhibitors. We are yet to see data from the MITCI study, which is where we have recruited the most patients, so the fact this data is being withheld until its presented is a small positive. The Storm data although a safety study is yet to demonstrate much in the way of objective responses. The study is complicated by varying dosages and varying cancer types being tested. Success in IV administered CAVATEK will significantly uplift the value of the IP, so we are largely still in the dark here around efficacy. I have also included comparable data from combining check points as well as the FDA approved oncolytic virus Imlygic in combination with Keytruda.
Phase 1b CAPRA trial - Updated to April 2017
Additionally the Study found that in stage four or late stage disease (melanoma with metastases) the objective response rates and disease control rates were 100% (5/5).
- Model - Advanced melanoma with CAVATAK + KEYTRUDA via direct injection
- Disease Control Rate - 10 from 11 patients (91%)
- Objective Responses - 8 from 11 Patients (73%)
- Stable Disease - 2 from 11 Patients (18%)
- Safety - No grade 3 or higher safety events
Phase 1b MITCI trial - Last Available Data
Phase 1b STORM- Updated to April 2017
- Model - Advanced melanoma with CAVATAK + YERVOY via direct injection
- Disease Control Rate - 14 from 17 patients (82%)
- Objective Responses - 9 from 17 Patients (53%)
- Stable Disease - 5 from 17 Patients (29%)
- Safety - No grade 3 or higher safety events
Phase 1b IMLYGIC + KEYTRUDA - MASTER KEY-265 STUDY
- Model - melanoma, NSCLC and bladder cancer with CAVATAK + KEYTRUDA via IV infusion
- Disease Control Rate - 9 from 13 patients (70%)
- Objective Responses - 1 from 13 Patients (8%)
- Stable Disease - 8 from 13 Patients (62%)
- Safety - No grade 3 or higher safety events
Phase 1/2 KEYTRUDA + YERVOY - KEYNOTE-029 STUDY
- Model - Advanced melanoma with IMLYGIC + KEYTRUDA
- Disease Control Rate – 11 from 16 patients (69%)
- Objective Response rate - 9 from 16 Patients (56%)
- Complete Response - 2 from 16 patients (12.5%)
- Partial Response - 7 from 16 patients (44%)
- Stable Disease – 2 from 16 Patients (13%)
- Safety – 33% grade 3 or higher safety events
http://australiansmall-capcompanies.blogspot.com.au/2017/04/viralytics-updated-for-aacr-annual.html
- Model - Advanced melanoma with KEYTRUDA + YERVOY
- Disease Control Rate – 57 from 72 patients (79%)
- Objective Response rate - 40 from 72 Patients (56%)
- Complete Response - 3 from 72 patients (4%)
- Partial Response - 37 from 72 patients (51%)
- Stable Disease – 17 from 72 Patients (24%)
- Safety – 36% grade 3 or higher safety events
Hi Guys The below is a summary of where the data sits currently....
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