Amgen (AMGN) announced positive results from two blood cancer studies on Kyprolis and Blincyto.
The company announced encouraging detailed results from its phase III ASPIRE (cArfilzomib, lenalidomide, and dexamethaSone versus lenalidomide and dexamethasone for the treatment of PatIents with Relapsed multiple myEloma) study on Kyprolis.
The study evaluated Kyprolis plus Celgene’s (CELG) Revlimid and low-dose dexamethasone in multiple myeloma patients whose disease relapsed after being treated with one to three prior regimens. Results from the study revealed that patients on the Kyprolis-Revlimid and dexamethasone 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).
Amgen intends to file regulatory applications for Kyprolis in the multiple myeloma indication in combination with Revlimid from the first half of 2015 on the basis of results from the ASPIRE study. The company expects accelerated approval for this indication in the U.S. may be converted to a full approval on the basis of the ASPIRE results.
We note that Kyprolis is already approved for the treatment of multiple myeloma patients who have received at least two prior therapies, including Velcade (bortezomib) and an immunomodulatory agent, and whose disease has progressed on or within 60 days of completion of the last therapy.
Kyprolis is also being evaluated in a couple of other late-stage studies (ENDEAVOR and CLARION) with data expected in 2016 and 2017 respectively. Kyprolis sales for the first nine months of 2014 came in at $240 million. Successful label expansion of the drug will boost sales further.
Amgen also announced positive results on another oncology product, Blincyto, from the phase II BLAST study. The study is evaluating Blincyto in patients suffering from minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukemia (ALL). Results revealed that 78% patients under Blincyto showed a complete MRD response after one treatment cycle. The MRD response is a measure of eradication of residual disease at the molecular level.
We note that Blincyto is already approved for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.
Our Take
The results from both the studies were encouraging. The company has progressed well with its pipeline and is expecting several data readouts and regulatory decisions in the coming quarters.
Amgen is also focusing on its biosimilar candidates which it believes represent a $3 billion plus opportunity. By 2019, Amgen intends to add 5 biosimilar products in its portfolio starting 2017.
Amgen is a Zacks Rank #3 (Hold) stock. Some better-ranked biotech stocks include Cytokinetics, Inc. (CYTK) and Biogen Idec Inc. (BIIB). Both carry a Zacks Rank #1 (Strong Buy).
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