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Re: WindedPenguin post# 45613

Tuesday, 11/06/2018 3:21:50 PM

Tuesday, November 06, 2018 3:21:50 PM

Post# of 48316
The stats sound about right. Very similar responses were observed in the predicted nonresponder trial for actual anti-pd-1 failures (20%). As Dr. Daud pointed out, this patient population has essentially no other options after failure on anti-pd-1. We know that approximately 10% observe some responses on chemo after anti-pd-1 failures, but those responses are rarely durable. It also sounds like these patients had very few CD8-positive T cells at baseline, just like those patients who progressed in the predicted nonresponder trial.

Even though 20% doesn't sound like much, I think the company is making a sound decision to continue pursuing the approval in anti-pd-1 refractory advanced melanoma patients. Again, these patients have no options after failure on anti-pd-1 treatment.

The market's reaction is puzzling. This isn't a treatment naive or all-comers trial, and I don't think approval odds have changed much. Of course we would all love to see higher response rates, but it really isn't necessary (for approval purposes) to achieve 50% BORR or whatever in these anti-pd-1 refractory patients. Unfortunately, some individuals misinterpreted the earlier trial's data and lumped all patients with prior checkpoint inhibitor therapies together to arrive at a high BORR. Some basic analysis would have resulted in the discovery that only 2/10 patients in the trial were actual anti-pd-1 failures who responded.
















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