Wednesday, September 28, 2016
Amgen Inc said on Tuesday its multiple myeloma drug, Kyprolis, did not fare better than Takeda Pharmaceutical Co Ltd's older therapy Velcade in a study involving patients who had not yet been treated for the disease.
The U.S. Food and Drug Administration has already approved Kyprolis for patients with relapsed or refractory multiple myeloma who have previously undergone treatment.
Patients treated with Kyprolis did not show a statistically significant improvement in slowing the cancer's progression compared with those given Velcade in the late-stage study.
Expectations of peak annual sales of about $2.3 billion for Kyprolis are now likely to cool, particularly since newly diagnosed patients constitute the largest market in terms of the number of patients and duration of therapy, some analysts said.
Multiple myeloma, a type of aggressive and incurable blood cancer that develops in the bone marrow, kills about 12,600 people annually and will be diagnosed in about 30,000 Americans this year, according to the American Cancer Society.
Baird analyst Brian Skorney said approval for previously untreated patients was "off the table" for now.
The head-to-head study tested Kyprolis against the older Velcade in patients who were also given the chemothereutic agent melphalan and the immunosuppressant prednisone, and were deemed to be ineligible for stem-cell transplants.
On a conference call with analysts, the company and experts said the "treatment landscape" for multiple myeloma was evolving dramatically and that melphalan/prednisone-based regimens were now rarely used due to their low efficacy and high toxicity.
Dr. Andrzej Jakubowiak, who was involved in the development of the Amgen drug, said on the call that the study was not the ideal way to evaluate Kyprolis in previously untreated patients.
Amgen, whose shares were down 1.2 percent at $171.45, said it would continue to explore the drug's benefit in combination with other agents.
Kyprolis is also being tested in a separate late-stage trial in combination with Celgene Corp's Revlimid and the steroid dexamethasone, or KRd, in this "front-line setting."
Jakubowiak said KRd was his first choice for previously untreated patients, and the results of the melphalan/prednisone study would not change this.
Kyprolis has already been shown to be superior to Velcade, which is expected to go generic in 2017, in the later stages of multiple myeloma.
Kyprolis faces greater competitive pressure as newer entrants in the multiple myeloma market gain traction, including Johnson & Johnson's Darzalex, Bristol-Myers Squibb Co's Empliciti and Takeda's Ninlaro.
The Amgen drug generated $172 million in revenue in the second quarter.
Source : reuters.com
