Amgen (AMGN - Analyst Report) suffered a major setback when its phase III study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) on multiple myeloma treatment, Kyprolis did not meet its primary endpoint.
The open-label study evaluated Kyprolis versus an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients suffering from relapsed and advanced refractory multiple myeloma.
However, the study did not meet its primary endpoint of improving overall survival (OS). The results from the study showed that there was an increase in the incidence of renal adverse events of all grades in the Kyprolis arm compared to the active control arm and the label.
Concurrent with the trial news, Amgen also announced that it initiated a voluntary recall for nine packaged lots of Aranesp (500 mcg) prefilled syringes due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Amgen recalled the lots from non-U.S. distributors, wholesalers and a number of hospital pharmacies.
We note that Kyprolis became a part of Amgen’s portfolio following its Oct 2013 acquisition of Onyx Pharmaceuticals.
Kyprolis gained accelerated approval in the U.S. in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies including Velcade (bortezomib) and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The results from the trial were disappointing. Positive results from the trial would have supported a regulatory filing in the EU.
We expect shares to be hit by the disappointing results from the trial.
Nevertheless, Amgen believes that the encouraging results released earlier in the month from the other phase III trial, ASPIRE, on Kyprolis will be sufficient to support regulatory submissions around the world.
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the industry include Allergan , Actelion Ltd. (ALIOF) and Gilead Sciences (GILD - Analyst Report). All three stocks sport a Zacks Rank #1 (Strong Buy).