Amgen blood cancer drug Kyprolis shows promise in trials


Multiple myeloma, a condition which occurs when a white blood cell known as plasma cell starts to multiply abnormally resulting in unhealthy levels of a protein called immunoglobulin that could cause organ damage, affects about 70,000 people in the U.S. and 230,000 people worldwide making it the second most prevalent form of hematologic cancer.

For this group of patients, a drug by biopharmaceutical company Amgen has shown promise in delaying the progression of the disease. On Monday, the Thousand Oaks-based biotechnology firm announced that in a clinical trial, patients with relapsed multiple myeloma who took its blood cancer drug Kyprolis along two other standard treatments lived significantly longer before their condition worsened than those who only received the standard therapy.

In the Aspire trial which involved nearly 800 patients with relapsed multiple myeloma who already received prior therapy, it took 26.3 months before the condition of patients who received Kyprolis with chemotherapeutic agent dexamethasone and Celgene's Revlimid started to worsen, which is 8.7 months longer when compared with the 17.6 months of progression free survival in patients who only had Revlimid and dexamethasone.

"The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing," said Onyx Pharmaceuticals president Pablo Cagnoni. "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."

Amgen, the largest independent biotechnology firm in the world, acquired Kyprolis when it bought South San Francisco-based Onyx Pharmaceuticals for a $10.4 billion deal last year. Kyprolis, which is seen to be central in Amgen's acquisition of Onyx Pharmaceuticals, has received conditional approval from the U.S. Food and Drug Administration based on a study that did not involve a control group but showed that 23 percent of the patients who did not respond to other therapies responded to Kyprolis.

Sanford Bernstein analyst Geoffrey Porges said that the result of the Aspire trial, which will be presented at the 56th Annual Meeting of the American Society of Hematology later this year, is crucial for Kyprolis to receive full approval in the U.S. and initial approval in Europe.

"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," Porges said.

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