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