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Re: None

Saturday, 10/15/2016 7:23:37 PM

Saturday, October 15, 2016 7:23:37 PM

Post# of 48316
When it is time for phase 2 interim data release, I will be paying close attention to ORR as an indicator of clinical effectiveness. Combination t-vec - which hasn't shown a systemic immune effect - and pembrolizumab demonstrated a 56% response rate in a phase 1 advanced metastatic melanoma trial. That trial, which enrolled something like 20 patients, was enough to convince Merck and Amgen to advance into their registration phase 3 trial. In addition, that combination is now being tested in other indications by both companies.

The 56% response rate suggests to me that t-vec can turn monotherapy pembrolizumab nonresponders into responders. Duration of response and complete responses are a whole other matter. If my math is correct, a 56% ORR is equivalent to a 28%-38% ORR in the UCSF/Oncosec/pembrolizumab phase 2 metastatic melanoma trial. This is based on a 30%-40% response rate for pembrolizumab monotherapy.

If we see ORR exceed 28%-38% in the UCSF/Oncosec/pembrolizumab phase 2 interim data, I think it would be safe to say that we are onto something enormous in melanoma and solid cancer therapy in general. We are just one month away.