Results

Endpoint Control N=347 B 7.5mg/kgN=345 B 15mg/kgN=351

PFS general Hazard ratio (95%CI) 0.75(0.62,0.90)P=0.002 0.82(0.68,0.98)P=0.03
Median PFS general (mos) 6.1 6.7 6.5
PFS censoring for NPT Hazard ratio (95%CI) 0.70(0.58,0.85) P=0.0004 0.78(0.64,0.95) P=0.0125
Response rate (%) 20 34 30
Response duration (mos) 4.7 6.1 6.1
Grade ≥3 AEs (%) 75 76 81
Grade ≥3 hypertension (%) 2 6 9
Grade ≥3 haemoptysis (%) <1 1.5 <1
AEs leading to death (%) 4 4 5