Sanofi said that it has published research results confirming a longer radiographic progression-free survival (rPFS) for Jevtana plus prednisone compared with abiraterone plus prednisone or enzalutamide in treating patients with metastatic castration-resistant prostate cancer (mCRPC).
|Sanofi's prostate cancer treatment Jevtana|
The study, called CARD, was a randomized, open-label treatment sequencing clinical study involving 62 sites across 13 European countries, enrolling 255 mCRPC patients previously treated with docetaxel and who progressed within 12 months on an androgen receptor (AR)-targeted agent, in any order.
The control group received abiraterone or enzalutamide, depending on the previous treatment experience.
As a result, the Jevtana-administered group showed more than a two-fold increase in the primary endpoint, rPFS, compared to the control group. Such results were consistent in all predefined subpopulations regardless of the duration of previous AR inhibitor treatment.
The Jevtana-administered group also extended the overall survival by 2.6 months from the control group’s 11.0 months and reduced the risk of death by all causes by 36 percent.
The company also confirmed significant improvements in other secondary endpoints, including progression-free survival (PFS), prostate-specific antigen (PSA), tumor, pain and symptomatic skeletal response.
The occurrence of serious adverse events in all grades was similar in the Jevtana-treated and control groups, and Sanofi did not observe any new safety issues associated with the drug.
“In this study, treatment with Jevtana significantly improved radiographic progression-free survival and overall survival compared with enzalutamide or abiraterone,” said Professor Ronald de Wit of Erasmus MC University Hospital and the lead investigator of the CARD study. “These results are exciting as they have the potential to impact treatment guidelines for metastatic prostate cancer and current clinical practice.”
The company published the results of the trial in the New England Journal of Medicine and also presented the data during the Presidential Symposium at the 2019 European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain.
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