Amgen’s Kyprolis doubles Velcade benefit in head-to-head study
pharmafile | December 5, 2015 | News story | Research and Development, Sales and Marketing | Amgen, Cancer, Kyprolis, Takeda, Velcade, multiple myeloma
Amgen has announced that its multiple myeloma therapy Kyprolis displayed superiority to Takeda’s Velcade in the Phase III ENDEAVOR study of 929 patients with relapsed multiple myeloma.
In results published in The Lancet Oncology, Kyprolis (carfilzomib) plus low-dose dexamethasone was found to achieve a progression-free survival rate twice that of Velcade (bortezomib) plus low-dose dexamethasone.
The data showed that patients treated with the Kyprolis combo achieved progression-free survival (PFS) of 18.7 months, compared to 9.4 months in those receiving the bortezomib combination that is a current standard of care in relapsed multiple myeloma- suggesting that Kyprolis and dexamethasone patients lived twice as long without their disease worsening as those treated with Velcade and dexamethasone.
The most common adverse events (that occured in more than 25% of patients) in the Kyprolis arm were diahorrea, anaemia, fatigue, dyspnea, pyrexia, and insomnia. Treatment discontinuation due to adverse events and on-study deaths were comparable between both arms.
“In this head-to-head comparison, carfilzomib plus dexamethasone resulted in a twofold decrease in the risk of progression or death, compared with bortezomib plus dexamethasone, a result that was consistent regardless of age or prior bortezomib exposure,” says study co-author and investigator, Meletios Dimopoulos, professor of clinical therapeutics at the National and Kapodistrian University of Athens school of medicine. “For patients with multiple myeloma, these results are clinically meaningful and translate to more than nine months without disease progression.”
Sean Harper, executive vice president of research and development at Amgen, says: “Coupled with results previously seen in the ASPIRE pivotal trial, data from the ENDEAVOR study support the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer. This is an important publication because it provides clinical evidence of Kyprolis’ potential to extend the time patients live without their disease progressing and improve the depth and duration of a response.”
The new study data follows the European Commission’s approval of Kyprolis in combination with lenalidomide and dexamethasone for multiple myeloma last month, when it became the irreversible proteasome inhibitor approved for the indication in Europe.
Kyprolis is also approved in the US for the treatment of patients with multiple myeloma who have received at least two prior therapies.
Data from the ENDEAVOR study are the basis of the supplemental New Drug Application (sNDA) of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma. The sNDA was accepted in September for priority review by the FDA and the Prescription Drug User Fee Act (PDUFA) target action date is January 22 2016.
Amgen also submitted the ENDEAVOR data to the European Commission for potential authorisation of Kyprolis in combination with dexamethasone in the European Union.
The Thousand-Oaks, California-based company added Kyprolis to its portfolio in 2013, with the $10.4 billion acquisition of manufacturer Onyx, which became a full Amgen subsidiary.
Joel Levy
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