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Amgen's Myeloma Drug Improves Overall Survival in Phase III

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Biotech major, Amgen, Inc. (AMGN - Free Report) has announced final data from the phase III ASPIRE study, which showed that a combination regimen of its drug, Kyprolis, significantly improved overall survival (OS) in patients with relapsed multiple myeloma.

Overall survival data from the study showed that patients with relapsed or refractory multiple myeloma, when treated with Kyprolis plus Celgene Corporation’s Revlimid (lenalidomide) and dexamethasone (KRd ), lived 79 months longer than those treated with Revlimid and dexamethasone (Rd) (median OS of 48.3 months for KRd versus median OS of 40.4 months for Rd). The data also showed that KRd reduced the risk of death by 21% compared with Rd. It is to be noted that patients received 18 cycles of KRd at relapse and thereafter continued treatment with Rd alone to progression. The data will be submitted to regulatory authorities for a potential label update.

We remind investors that Kyprolis (twice weekly) is already approved for use in combination with dexamethasone or with Revlimid (lenalidomide) plus dexamethasone based on the primary analysis of progression-free survival (PFS) data from the ASPIRE study.

So far this year, Amgen’s shares are up 18.5%, better than the 7.1% increase registered by the Zacks categorized Biomed/Genetics industry.

We believe that this overall survival data, if added to the drug’s label, should help drive Kyprolis’ market share, mainly for triplet use. At the first quarter conference call, Amgen had said that in the second-line multiple myeloma market, triplet regimens are used in approximately one-third of patients. The company added that despite increasing competition, Kyprolis gained 50% market share for new patient starts in this segment.

We note that in February this year, Amgen announced OS data from the head-to-head ENDEAVOR study, which also showed that patients with relapsed or refractory multiple myeloma lived 7.6 months longer when treated with Kyprolis and dexamethasone compared to those treated with Velcade and dexamethasone. The data also showed that Kyprolis and dexamethasone reduced the risk of death by 21% compared to Velcade and dexamethasone.

Kyprolis is being evaluated in a couple of other studies for potential label expansion. Amgen is evaluating a weekly dosing regimen of Kyprolis in a phase III study (ARROW) in relapsed and refractory multiple myeloma patients. Data should be out in 2019.

Meanwhile, Amgen has also collaborated with Johnson & Johnson (JNJ - Free Report) to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for the treatment of multiple myeloma. A phase III registrational study evaluating the Kyprolis/Darzalex combination and dexamethasone compared to Kyprolis and dexamethasone alone in patients with multiple myeloma who have had one, two or three prior lines of therapy has been recently initiated.

Amgen carries a Zacks Rank #3 (Hold). A better-ranked stock in the same space is Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Vertex Pharma have rallied 23.1% so far this year. Also, its earnings estimates for 2017 moved up 7.5%, while the same for 2018 climbed 26.7% in the last 60 days. Its earnings performance has been pretty impressive as well, with consistent positive surprises. The company’s average earnings beat for the last four quarters is 406.25%.

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