Amgen's latest drug Kyprolis was shown to help patients with relapsed multiple myeloma live longer compared to standard treatment.
Patients treated with Kyprolis lived longer without their blood cancer getting worse than patients on the standard treatment, though according to Amgen, the analysis indicated that it did not quite reach statistical significance.
The success of the Kyprolis trial, however, has eased pressures on the company's management team.
They found that on a combination of Kyprolis and Revlimid, it took 26.3 months for patients to experience disease progression compared to 17.6 months for those on Revlimid and dexamethasone. But again, the results trended towards higher survival, but were not statistically significant.
The results of the trial have been consistent with current warnings on the Kyprolis label, and no other safety signals were identified.
"We are excited about these clinical results and the positive prospects they suggest for patients with multiple myeloma," said Robert Bradway, chairman and CEO of Amgen. "Our mission at Amgen is to serve patients by advancing medicines that address serious disease. Kyprolis is an important building block in our robust, differentiated pipeline."
Kyprolis is the center of Amgen's $10 billion acquisition of Onyx Pharmaceuticals. The results from this study, Aspire, and the Phase III trial, Focus, were important for jumpstarting Kyprolis sales growth.
"The Aspire study is critical for the conversion of the drug's current approval from accelerated, or conditional, approval to full approval in the U. S. as well as for initial approval of the drug in Europe," said Sanford Bernstein analyst Geoffrey Porges.
The drug was granted accelerated approval after former therapies stopped working. This new data may help the drug transition into full approval.
Porges also said that it's good news for Celgene since it provides evidence that Revlimid is a key drug for myeloma therapies.
Right now, Kyprolis is only a third line drug meaning that patients have to relapse twice before being put onto the medication. This data could transition Kyprolis to a second-line drug, meaning it can be given to patients who have relapsed once.
"In the treatment of patients with multiple myeloma, periods of remission become shorter following each treatment regimen, underscoring the need for new options," said Pablo Cagnoni, president of Onyx Pharmaceuticals. "The ability of novel therapies to produce deep and durable responses may, one day, transform this uniformly fatal disease to one that is chronic and manageable."
