Published 31 January 2018
Amgen has received a positive opinion from the Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to add updated overall survival data to Kyprolis label.
CHMP has adopted a positive opinion recommending a label variation for Kyprolis (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade [bortezomib] and dexamethasone [Vd]).
The ENDEAVOR trial demonstrated that Kd reduced the risk of death by 21 percent and increased OS by 7.6 months versus Vd in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01).
translational sciences and oncology senior vice president Dr David Reese said: “The positive opinion issued by the CHMP for KYPROLIS, which, in combination with dexamethasone, achieved superior overall survival versus Velcade and dexamethasone, underscores our commitment to helping patients live better, longer lives.”
“We’re proud to share these results with European regulatory authorities and believe KYPROLIS is advancing the standard of care for patients with relapsed or refractory multiple myeloma.”
KYPROLIS is approved in the European Union (EU) for use in combination with dexamethasone or with lenalidomide plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
The Kd regimen of twice-weekly KYPROLIS administered at 56 mg/m2 and the KRd regimen of twice-weekly KYPROLIS administered at 27 mg/m2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase 3 trials in relapsed or refractory multiple myeloma patients (Kd versus Vd and KRd versus lenalidomide and dexamethasone).
The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated KYPROLIS in combination with low-dose dexamethasone versus bortezomib with low-dose dexamethasone in relapsed or refractory patients who previously received at least one, but not more than three, prior therapeutic regimens.
The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death. The primary analysis was published in The Lancet Oncology and is described in the Prescribing Information.
Patients received treatment until progression with KYPROLIS as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treatment cycles, along with low-dose dexamethasone (20 mg). For cycle one only, KYPROLIS was administered at 20 mg/m2 on days 1 and 2, and if tolerated was escalated to 56 mg/m2 from day 8 of cycle one onwards.
Patients who received bortezomib (1.3 mg/m2) with low-dose dexamethasone (20 mg) were treated with Velcade administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regional regulatory approval of bortezomib.
More than 75 percent of the patients in the control arm received bortezomib subcutaneously. This study was conducted at 235 sites worldwide.
KYPROLIS is approved in the European Union for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
KYPROLIS is also approved in Argentina, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, S. Korea, Canada, Qatar, Switzerland, United Arab Emirates, Turkey, Russia, Brazil, India, Oman and the United States. Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
Source: Company Press Release