Amgen Inc. AMGN announced that a three-drug combination regimen of its multiple myeloma (MM) drug Kyprolis improved progression-free survival (PFS) in a phase III study.
The phase III CANDOR study evaluating Amgen's Kyprolis + dexamethasone and Johnson & Johnson's JNJ Darzalex in patients with relapsed or refractory multiple myeloma, met the primary endpoint of PFS compared to Kyprolis plus dexamethasone (Kd) alone.
In the study, treatment with the three-drug Kyprolis combo (KdD) led to a reduction in the risk of progression or death by 37% in patients with relapsed or refractory MM.
The median PFS for patients who received Kd alone was 15.8 months. However, as of the cut-off date, the median PFS has not been reached for patients in the KdD arm. Also, there were a higher number of adverse events like thrombocytopenia, anemia, diarrhea, hypertension among others reported in the KdD regimen compared to Kd.
Notably, this is the first phase III study, evaluating the combo of Kyprolis and Darzalex for treating the given patient population. The primary endpoint was PFS while the key secondary endpoints were overall response rate, minimal residual disease and overall survival.
The randomized, open-label CANDOR study was initiated by Amgen as part of its collaboration agreement with Janssen, a subsidiary of J&J, which is also co-funding the study along with Amgen.
Amgen plans to present data from the above study at an upcoming medical conference. The company also plans to submit the results for regulatory approvals.
Shares of Amgen have inched up 0.4% so far this year against the industry’s decline of 1.8%.
We remind investors that Kyprolis is already approved as a monotherapy as well as in combination with dexamethasone or Celgene Corporation's CELG Revlimid (lenalidomide) plus dexamethasone for the treatment of relapsed/refractory MM in patients who have received one to three lines of therapy.
During the first half of 2019, Kyprolis generated sales of $512 million, reflecting an increase of 5.6% year over year, primarily driven by volume growth in the United States.
Zacks Rank & Another Key Pick
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