Jevtana (cabazitaxel) demonstrated improved survival over second androgen receptor-targeted agent in patients with metastatic castration-resistant prostate cancer. The data were published Sept. 30 in The New England Journal of Medicine.
Patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and who progressed within 12 months on an androgen receptor (AR)-targeted agent (abiraterone or enzalutamide) experienced significantly longer radiographic progression free survival with Jevtana plus prednisone compared with abiraterone plus prednisone or enzalutamide.
Overall survival with Jevtana was also significantly longer. These findings from the CARD study were presented Sept. 30 at ESMO.
“In this study, treatment with Jevtana significantly improved radiographic progression free survival and overall survival compared with enzalutamide or abiraterone,” lead investigator on the CARD study, Ronald de Wit, of Erasmus MC University Hospital, Rotterdam, The Netherlands, said in a statement. “These results are exciting as they have the potential to impact treatment guidelines for metastatic prostate cancer and current clinical practice.”
CARD is a randomized, open-label, treatment sequencing clinical study involving 62 sites across 13 European countries, enrolling 255 patients (median aged 70 years, 31% aged over 75 years) with mCRPC who were previously treated with docetaxel and who progressed within 12 months on an AR-targeted agent, in any order. These patients were randomized 1:1 to Jevtana (25 mg/m2 intravenously every three weeks, daily prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1,000 mg plus prednisone, daily) or enzalutamide (160 mg daily; patients received abiraterone if they were previously treated with enzalutamide, or enzalutamide if they were previously treated with abiraterone).
The study’s primary endpoint was rPFS, which more than doubled with Jevtana treatment (N=129) compared to abiraterone or enzalutamide (N=126; median 8.0 vs 3.7 months; HR=0.54; 95% CI, 0.40–0.73; p<0.0001). Patients treated with Jevtana experienced an improvement in rPFS in all pre-specified subgroups, irrespective of the timing of the previous alternative AR-targeted agent, before or after docetaxel. Jevtana also significantly improved a key secondary endpoint, OS (median 13.6 vs 11.0 months; HR=0.64; 95% CI, 0.46–0.89; p=0.0078), reducing the risk of death from any cause by 36% compared with abiraterone or enzalutamide.
Other key secondary endpoints all favored Jevtana: progression free survival (median 4.4 vs 2.7 months; p<0.0001); confirmed prostate specific antigen (35.7% vs 13.5%; p=0.0002) and tumor responses (36.5% vs 11.5%; p=0.004). Pain response (45.0% vs 19.3%; p<0.0001) and time to symptomatic skeletal events (not reached vs 16.7 months; p=0.0499) were also significantly improved with Jevtana treatment.
