@kinatsofrim@avidresearch SVR with all failed drugs also correlated with survival benefit. I get the argument but think KM analysis is weak when pressure tested. If real, then ya sure should be approved!
@kinatsofrim@avidresearch unmet need in front-line vs later line combined with Pac only in small subset (thrombocytopenic) where there was not other option. Confounded by clinical hold resulting in smaller N in FDA's own words. Still has to hit TSS in PACIFICA
OS signal is sensitive to information fraction IMO. Navitoclax had ~ 2.4 ORR for VAF reduction and greater % pts achIeving SVR35. The entire reason SVR ever accepted was the know correlation with surivival. IT HAS ALWAYS BEEN PROSPECTIVELY LINKED in the past 15 years. The NCCN argument I could buy...maybe
KOLs said the same thing during Navitoclax about TSS and FDA understanding. And how do you believe a KM curve with so few events, so much censoring, and with the median f/u for Seli being < where the deaths started happening on the control arm? HALF the pts hadn't reached 11.6 mo f/u