Replies to post #36060 on OncoSec Medical Inc (ONCSQ)

[Waitforit53]

Actually Titan there is a difference, Refractory refers more to the stubborn tumors that although they have a low TIL environment are still resistant to a treatment regimen due to other factors.

My understanding is it's the same trial. Anytime there is talk about a metastastic melanoma combination study, They can be referred to as a phase 2 or phase 2B clinical trial. Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose. I do think that they have been working with both aspects during this phase 2 trail.

[hschlauch]

Refractory is more inclusive. I think the phase 2 trial described on slide 21 is a registration study, i.e. one for which a NDA will be based.

Refractory includes initial nonresponders or patients who become nonresponsive, e.g. partial responders, to pembrolizumab. I estimate that the refractory population is approximately 90% of all unresectable stage III/IV metastatic melanoma patients who are treated with monotherapy pembrolizumab. I believe only approximately 10% of patients experience durable complete responses with monotherapy Keytruda in metastatic melanoma.

[chickpea598]

I was under the impression this is the final registration trial for the combo study because the title states "accelerated approval trial design" and it is 6 month duration.