NLNK / INCY:
I agree with you that the INCY cohort appears to be worse off at baseline. How much that can impact the PFS data is anyone's guess. Perhaps NLNK IR could share how their Stage IV cohort fared in the PFS measurement?
The other factor that would help the comparison is to know the PD-L1 +/- split. PD-L1 - patients do not appear to respond all that often (1 responder of 6 in INCY cohort), so if there is an imbalance there between the trials, it would have to be brought into consideration.
For the record, I'm not too focused on the ORR of these regimens. I think durability (DOR / PFS) are the key metrics.
A couple of things that strike me as curious about these studies:
- I find it a bit surprising the NLNK combo appear to have actually reduced many AEs versus pembro alone. Grade 3/4 hyperglycemia is down, anemia abrogated and lymphopenia not even on the AE table for the combo. That's good I guess, but surprising.
- I think INCY isn't being fully forthcoming with their PFS data. The cutoff they're using for these presentations is rather far from the date of presentation. They've generally been a trustworthy management team, but I have an uneasy feeling around these data slices they present.
- I'm not sure how NLNK got their 12.9 month PFS number. From looking at the change in tumour volume over time graph, only about 1/4 of the study participants seem to have made it to 52 weeks at this point. I assume it's an estimate of sorts, but I'd keep an eye on it.
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