[Beacon Staff]

Kyprolis - Initial results from Phase 3 ASPIRE trial

by Beacon Staff on Mon Aug 04, 2014 9:52 am

Some important news this morning -- particularly for the myeloma community in Europe (and probably Canada as well).

Interim results were announced this morning of the ASPIRE trial testing Kyprolis-Revlimid-dex versus Revlimid-dex in relapsed myeloma. The results showed Kyprolis improved the efficacy of just Revlimid-dex alone. These results could help Kyprolis win regulatory approval late next year, or early in 2017, in Europe and Canada. More at the press release below (at the Myeloma Beacon).

Amgen Announces Phase 3 ASPIRE Trial Of Kyprolis® In Patients With Relapsed Multiple Myeloma Met Primary Endpoint, August 4, 2014.

Excerpts:

"... a planned interim analysis demon­strated that the Phase 3 clinical trial ASPIRE ... met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001)."

" While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favor of KRd that did not reach statistical significance."

"The safety profile observed in this study is consistent with the current U.S. Kyprolis label, including the rate of cardiac events. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. No new safety signals were identified."

"Results from the ASPIRE study will form the basis for regulatory submissions throughout the world be­gin­ning in the first half of 2015. In the U.S., the data may support the conversion of accelerated approval to full approval and expand the current indication."

[Nancy Shamanna]

Re: Kyprolis - Initial results from Phase 3 ASPIRE trial

by Nancy Shamanna on Mon Aug 04, 2014 11:18 am

Thanks Beacon Staff for keeping us all informed of the news about the phase 3 study for Kyprolis (ASPIRE). In the quote from the press release it does say that regulatory approval may be sought in 'the rest of the world', i.e. outside the U.S. IMO, any new drugs available to relapsed patients would be welcome. In Canada, a drug probably could not be considered for approval by Health Canada without data from phase 3 trials. Will be watching for more news on the acceptance of Kyprolis in the countries of the EU, and in other countries too, hopefully.