There's another abiraterone phase III trial but in chemo/biologic naive CRPC patients, who failed anti-androgen therapy, also under an SPA. Primary endpoints are OS and PFS but JNJ can file based on PFS.
The efficacy result is on par with Cabazitaxel because these two were tested in same patient population. The difference is in the control arm, mitoxantrone and prednisone/prednisolone vs prednisone/prednisolone and placebo.
Cabazitaxel primary end point (overall survival) showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 28% [HR=0.72 (95% CI: 0.61-0.84); P<0.0001] with an improvement in the median overall survival of 15.1 months vs. 12.7 months in the mitoxantrone and prednisone/prednisolone combination arm.
Abiraterone acetate in combination with prednisone/prednisolone led to a 35% reduction in the risk of death (HR=0.65; 95% CL: 0.54-0.77; P<0.0001) that translated into a median 14.8 month survival compared with 10.9 months for patients who received prednisone/prednisolone and placebo.
Abiraterone acetate has advantage in AE profile relative to Cavazitaxel.