[Nancy Shamanna]

Re: Kyprolis - Topline results of Phase 3 FOCUS trial

by Nancy Shamanna on Mon Aug 18, 2014 1:09 pm

Thanks Beacon Staff, that is a clarification about clinical trials. I thought that the previous Phase 2 trial that was used for the approval of Kyprolis in the US, did include dexamethasone as part of the treatments. Perhaps there was one 'arm' with and one 'arm' without dex though, can't remember! It was about two years ago I think.

It's good that Kyprolis has proven to be useful in some situations, since so much work and funding has gone into developing and testing it.

[Beacon Staff]

Re: Kyprolis - Topline results of Phase 3 FOCUS trial

by Beacon Staff on Mon Aug 18, 2014 1:14 pm

Hi Nancy,

The trial for U.S. approval was, indeed, a Phase 2 trial. However, like most Phase 2 trials, it did not include a comparator arm. All patients in the study received just Kyprolis.

[Nancy Shamanna]

Re: Kyprolis - Topline results of Phase 3 FOCUS trial

by Nancy Shamanna on Mon Aug 18, 2014 1:43 pm

Thanks Beacon Staff, This thread prompted me to go back and look at the Beacon article dated July 26, 2012, which was about the approval of Kyprolis on phase 2 data. In that article, two phase 3 trials are described which were necessary to also be completed by Onyx.

One was ASPIRE (kyprolis/Revlimid/dex vs. Revlimid/dex)

The other phase 3 trial was ENDEAVOR (kyprolis/dex vs. Velcade/dex).

It must have been the ENDEAVOR trial I was thinking of...sorry...this whole process of following clinical trial data is still somewhat new to me!