Amgen's Kyprolis Fares Better than Velcade in Study - Analyst Blog
Biotech major Amgen AMGN and its subsidiary Onyx Pharmaceuticals, Inc. announced that multiple myeloma drug, Kyprolis, fared well in a planned interim analysis of the phase III head-to-head ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) study.
The study is comparing Kyprolis in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone. The primary endpoint of progression-free survival (PFS) was met with relapsed multiple myeloma patients on Kyprolis living twice as long without their disease worsening and demonstrating statistically and clinically significant superiority over Velcade (median PFS: 18.7 months versus 9.4 months).
Moreover, the Kyprolis arm demonstrated superiority over the Velcade arm in secondary objectives like overall response rate and neuropathy events. However, cardiac and renal failure rates were higher in the Kyprolis arm. The incidence of hypertension and dyspnea in the Kyprolis arm was also higher compared to Velcade and that observed in the phase III ASPIRE study.
Overall survival data is yet to mature. Full data will presented at the annual meeting of the American Society of Clinical Oncology.
Kyprolis, which became a part of Amgen’s portfolio following its acquisition of Onyx, delivered sales of $331 million in 2014. Amgen is currently looking to convert Kyprolis’ accelerated approval to full approval in the U.S. Kyprolis had gained accelerated approval in the U.S. in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies including Velcade and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The company is also looking to get Kyprolis’ label expanded in the U.S. and approved in the EU for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
Amgen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Isis Pharmaceuticals, Inc. ISIS, Theravance Inc. THRX and Alnylam Pharmaceuticals, Inc. ALNY. While Isis and Theravance are Zacks Rank #1 (Strong Buy) stocks, Alnylam is a Zacks Rank #2 (Buy) stock.
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