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DewDiligence

10/11/10 4:41 PM

#106174 RE: genisi #106173

Nice results for JNJ’s Abiraterone:

http://finance.yahoo.com/news/Abiraterone-Acetate-prnews-2610886646.html?x=0&.v=1

HR for overall survival: 0.65
95% CI: [0.54, 0.77]
p<0.0001

genisi

10/11/10 5:28 PM

#106183 RE: genisi #106173

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.

http://clinicaltrials.gov/ct2/show/NCT00887198?term=Abiraterone+phase+iii+prostate&rank=1

jq1234

10/11/10 7:04 PM

#106188 RE: genisi #106173

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.