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Re: Titan V post# 36060

Friday, 10/07/2016 1:29:31 PM

Friday, October 07, 2016 1:29:31 PM

Post# of 48316
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.