Biotech Values

[JohnWayne]

I would guess that upwards of 80% of Phase 3 I-O studies have PFS and OS co-primaries. To your point, everyone is jockeying for first-to-market positioning given lack of differentiation. Most of these studies were started on basis of a few dozen patients from Phase 1 cohorts that often differ dramatically in terms of eligibility criteria compared to the Phase 3. Not your typical big pharma development pathway.

Conventional wisdom is that PFS isn't best endpoint for I-O, but at the same time, PFS has given MRK a huge advantage in 1L NSCLC with monotherapy in PD-L1+ and chemo combo in unselected. PFS can be a great endpoint for I-O with right mix of smart trial design and luck.