Amgen Inc. AMGN announced that results from a pivotal head-to-head phase III ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) study on Kyprolis were published in The Lancet Oncology.
The study comparing Kyprolis in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone was conducted in patients with relapsed multiple myeloma. The primary endpoint of progression-free survival (PFS) was met with patients on Kyprolis plus dexamethasone living twice as long without their disease worsening and demonstrating superiority over Velcade plus dexamethasone (18.7 months versus 9.4 months, respectively). Overall survival data is yet to mature and continues to be monitored.
Amgen also announced the presentation of new key data evaluating Kyprolis-based regimens in patients with relapsed multiple myeloma. The data showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to Velcade plus dexamethasone across a range of difficult-to-treat populations, particularly those with high risk and previously treated disease. Data was presented at the annual meeting of the American Society of Hematology.
Currently, Amgen is working on expanding Kyprolis’ label further, both in the U.S. and EU. In a separate press release, the company announced submitting a regulatory application to the European Medicines Agency seeking approval for Kyprolis in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
Kyprolis is also under priority review in the U.S. for the same indication with a response from the FDA expected by Jan 22, 2016. We note that regulatory filings both in the U.S. and EU were submitted on the basis of phase III ENDEAVOR data.
We remind investors that last month Kyprolis gained approval in the EU in combination with Celgene Corporation’s CELG Revlimid and dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
The drug, which became a part of Amgen’s portfolio following its acquisition of Onyx, registered sales of $364 million in the first nine months of 2015.
Inks Cancer Immunotherapy Deals with Merck
Amgen announced a couple of cancer immunotherapy collaborations with Merck & Co. Inc. MRK. The first deal will evaluate the safety and efficacy of Amgen’s Blincyto (CD19 bispecific T cell engager) in combination with Merck’s Keytruda (anti-PD-1 therapy) in an open-label, multicenter, randomized phase Ib/III study in patients with diffuse large B-cell lymphoma.
Meanwhile, the second deal will assess the safety and efficacy of Amgen’s AMG 820 (anti-colony-stimulating factor 1 receptor antibody) in combination with Keytruda in an open-label phase I/II study in patients with select advanced solid tumors including non-small cell lung, colorectal and pancreatic cancers.
Amgen is a Zacks Rank #3 (Hold) stock. Achillion Pharmaceuticals, Inc. ACHN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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