Amgen’s (AMGN) shares were up 2.47% with the company announcing highly-awaited results from the phase III ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) study on multiple myeloma treatment, Kyprolis. Kyprolis achieved the primary endpoint of the study – progression free survival.
The study evaluated Kyprolis plus Celgene’s (CELG) Revlimid and low-dose dexamethasone in multiple myeloma patients whose disease had relapsed after being treated with one to three prior regimens.
The planned interim analysis showed that patients on the Kyprolis-Revlimid regimen lived significantly longer without their disease worsening compared to patients on just Revlimid and low-dose dexamethasone (26.3 months versus 17.6 months).
The rate of cardiac events was similar to the current product label in the U.S. with no new safety issues coming up.
While the top-line results are impressive, data for the secondary endpoint — overall survival — are not yet mature. Amgen noted that although the analysis shows a trend in favor of the Kyprolis-Revlimid regimen, it did not reach statistical significance.
Our Take
The ASPIRE study results are very important for Amgen which is looking to expand its pipeline and bring new products to market. Kyprolis became a part of Amgen’s portfolio following its Oct 2013 acquisition of Onyx Pharmaceuticals. Kyprolis gained accelerated approval in the U.S. for the treatment of patients with multiple myeloma who have received at least two prior therapies including Velcade (bortezomib) and an immunomodulatory agent (IMiD), and whose disease has progressed on or within 60 days of completion of the last therapy.
Amgen intends to file for regulatory approval on the basis of the ASPIRE data in the first half of 2015. The data from this study could help the company convert accelerated approval to full approval and expand the patient population. Additional treatment options for multiple myeloma are needed as periods of remission become shorter following each treatment regimen.
While label expansion should boost Kyprolis sales significantly which were $146 million in the first half of 2014, we note that the multiple myeloma space is getting more competitive given the presence of products like Pomalyst.
Amgen is a Zacks Rank #3 (Hold) stock. Some better-ranked biotech stocks include Cytokinetics, Inc. (CYTK) and Actelion Ltd. (ALIOF). Both carry a Zacks Rank #1 (Strong Buy).
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