COU-AA-302 trial unblinded, placebo arm advised to start abirateroneCOU-AA-302 trial unblinded, placebo arm advised to start abiraterone
Posted on 9th March 2012
The COU-AA-302 study on abiraterone acetate Plus Prednisone for Asymptomatic or Mildly Symptomatic Chemotherapy-Naive Patients with Metastatic Castration-Resistant Prostate Cancer, a randomized, double-blind, placebo controlled study has just been un-blinded on 8th March 2012 by The Independent Data Monitoring Committee (IDMC) based on an unanimous decision. The patients in the placebo arm have been advised to cross over to the treatment arm
This COU-AA-302 study is based on treatment with abiterone + prednisolone in patients who have not been started on docetaxel. There was evidence of significant benefit in the primary endpoints of the study ie. radiographic progression-free survival and overall survival.
These landmark results in COU-AA-302 study will be submitted for publication in a peer-reviewed journal soon, presented in a major conference soon and will likely get a FDA fast track approval soon.
In another few months, the standard drug of choice in early mCRPC may soon be abiraterone.
It is best that current trials, if done, should concentrate on:
1. Abiterone (as control) vs MDV – 3100
2. Abiterone (as control) vs TAK - 700
MDV-3100 will probably get a fast-track approval soon (anytime now) as per the presentation at the recent Genito-urinary seminar by ASCO and will be another standard treatment for mCRPC post-docetaxel
TAK – 700 was just presented at the EAU meeting yesterday, and shows good results in phase 2 trials
However, the difficulty in bringing these drugs here to Malaysia (MDV AND TAK) is understandably DIFFICULT.
Rgds
Dr Rajeentheran Suntheralingam
Source:
COU-AA-302 trial unblinded, placebo arm advised to start abiraterone
