Table 1.
Item | Squamous | Non-squamous |
---|---|---|
Population | Previously treated locally advanced or metastatic non-small cell lung cancer after prior chemotherapy | |
Comparator | Docetaxel | |
Proportional hazards on OS | Yes | No |
Proportional hazards on PFS | No | No |
Extrapolation of OS: nivolumab arm | Spline 2-knot hazard (generalised gamma) | Log-normal (hybrid-exponential) |
Extrapolation of OS: docetaxel arm | Spline 2-knot hazard (generalised gamma) | Log-normal (hybrid exponential) |
Extrapolation of PFS: nivolumab arm | Spline 1-knot hazard (hybrid exponential) | Spline 2-knot odds (hybrid exponential) |
Extrapolation of PFS: docetaxel arm | Spline 1-knot hazard (hybrid exponential) | Spline 2-knot odds (hybrid exponential) |
TTD nivolumab arm | KM | KM |
TTD docetaxel arm | KM | KM |
PF utility | 0.693 | 0.713 |
PD utility | 0.509 | 0.688 |
Clinical stopping rule | 2-year stopping rule | |
Continued treatment effect | Nivolumab’s treatment effect could last up to 20 years |
KM Kaplan-Meier, OS overall survival, PD progressed disease, PF progression free, PFS progression-free survival, TTD time-to-treatment discontinuation