Biotech Values

[mcbio]

If you think mapping historical data onto your trial is difficult ... it ain't nothin' compared to trying to map Response data onto survival.

Yeah, I was wondering how a CR would be applied to OS numbers. The OS numbers are expressed as a length of time but with a CR, there obviously is no event so seems confusing to me how this could be included in the OS numbers and expressed as a length of time. (Maybe it's just as simple as calculating the time the patient began therapy until the time the trigger is reached, but I suspect with your response it's far from that simple.) I assume you can't exclude a CR from OS data since CR is the holy grail behind any cancer treatment and it would be unfair to exclude that. Anyways, hopefully there are more CRs in this Phase 2 trial and hopefully they occur in the selumetinib arm.

Separately, regarding your comment on the estimate of blended median survival of between about 10 and 12.5 months for the selumetinib arm, do you have any comments on the likelihood of selumetinib being stat sig on OS if the OS numbers come in at, say, 11 months for the selumetinib arm, and, say, 8 months for the control arm? Is it likely that would be a stat sig OS benefit? I'm not 100% certain on whether or not this melanoma trial is powered to detect stat sig on OS benefit. ARRY's prior comments on powering were just specific to the NSCLC trial, but I'm not sure if that's just because that only came up in connection with a question that was specific to the NSCLC trial (and not also the melanoma trial) or if the lack of reference to the melanoma trial means that this trial is in fact powered to detect a stat sig OS benefit (the primary endpoint of this trial).