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Re: DewDiligence post# 196948

Friday, 11/06/2015 2:21:34 PM

Friday, November 06, 2015 2:21:34 PM

Post# of 252484
INCY:

I think people are misreading the NSCLC data and that is the major reason for the fall.

The results are fine for a dose-ranging trial. Caveats for small numbers and all that, but the melanoma results show an incremental uptick above pembro alone.

In NSCLC, pembro alone has an ORR of ~20%. However, when PD-L1 expression is measured and those patients with a proportional score of >49% are analyzed, then the ORR goes up to ~40%. I think people look at that 40% number for pembro and the 38% number for this trials pembro + IDO and write it off.

This combo trial provided data for all PD-L1 expression levels. For the 10 NSCLC patients, only 2 had scores >49% while 3 had results pending. So at most, 5 of these 10 will meet that >49% threshold. If you treat these combo data as an all-comers trial wrt to PD-L1 expression, then the more appropriate comparison is the 20% pembro ORR versus the 38% ORR in this combo trial.

This obviously has caveats with respect to the skepticism surrounding the overall reliability of PD-L1 expression and its clinical significance, and the small numbers in this combo trial. But a small effort at making a more comparable comparison gives a more nuanced view of the data.

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