Shares of Amgen fell slightly—by 1.5 percent, to $170.90—this week on the report that its multiple myeloma drug—carfilzomib, under the brand name Kyprolis–did not outperform the competition in a head-to-head, late-stage study regarding efficacy on previously untreated patients.
The United States Food and Drug Administration had already approved Kyprolis for multiple myeloma patients who had relapsed or for those with refractory multiple myeloma who have undergone at least one other treatment.
Multiple myeloma is a type of aggressive and incurable blood cancer that develops specifically in the bone marrow. The condition claims 12,650 lives every year, and has an estimated diagnosis rate of 30,330 Americans this year, as described by the American Cancer Society.
Unfortunately, the latest study tested Kyprolis against Takeda Pharmaceutical Co Ltd’s Velcade in patients who had also received chemothereutic agent melphalan along with the immunosuppressant prednisone but, for one reason or another, were ineligible for stem-cell transplant.
According to the researchers, those who received Kyprolis did not, in fact, experience a notably significant benefit in slowing the progression of cancer over those patients who were taking Velcade. Basically, then, that means Kyprolis did not succeed in providing more benefit than the competition; it’s goal was “progression-free survival”.
Amgen executive vice president of Research and Development, Sean E. Harper, notes, “The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting. However, the myeloma landscape has changed dramatically since the design of the CLARION study with very few newly diagnosed patients treated with melphalan-based regimens, particularly in the United States,” he added. “We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”
Currently, Kyprolis is the only therapy approved in the United States to treat relapsed multiple myeloma. Furthermore, it can be versatile: used as a single agent or a doublet or even a triplet combination. In addition, the drug generated a remarkable $172 million in revenue through the second quarter (ending June 30).
Harper goes on to say, “Based on studies in the Kyprolis label, including the ENDEAVOR study, a head-to-head comparison of Kyprolis to Velcade in patients with relapsed or refractory multiple myeloma, we know Kyprolis to be a major advance in proteasome inhibitor therapy.”