CARD study of Jevtana meet primary endpoint in prostate cancer and is published in NEJM.- Sanofi

Data published in the New England Journal of Medicine showed that patients with metastatic castration-resistant prostate cancer (mCRPC) 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 (rPFS) with Jevtana (cabazitaxel), from Sanofi, plus prednisone compared with abiraterone plus prednisone or enzalutamide. Overall survival (OS) with Jevtana was also significantly longer.

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). 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), 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 (PFS) (median 4.4 vs 2.7 months); confirmed prostate specific antigen (PSA) (35.7% vs 13.5%) and tumor responses (36.5% vs 11.5%). Pain response (45.0% vs 19.3%) and time to symptomatic skeletal events (not reached vs 16.7 months) were also significantly improved with Jevtana treatment.

The incidence of grade at least 3 adverse events (AEs) was 56.3% with Jevtana vs 52.4% with AR-targeted agents. Key grade at least 3 treatment-emergent AEs with Jevtana versus AR-targeted agents were renal disorders (3.2% vs 8.1%), infections (7.9% vs 7.3%), musculoskeletal pain/discomfort (1.6% vs 5.6%), cardiac disorders (0.8% vs 4.8%), asthenic conditions (4.0% vs 2.4%), diarrhea (3.2% vs 0), peripheral neuropathy (3.2% vs 0) and febrile neutropenia (3.2% vs 0). Serious AE rates of any grade were similar for Jevtana treatment (38.9%) and treatment with an AR-targeted agent (38.7%). AEs led to death in 7 vs 14 patients (5.6% vs 11.3%) for Jevtana compared to AR-targeted agents. No new safety signals were observed. These findings from the CARD study were presented in the Presidential Symposium of the 2019 European Society of Medical Oncology (ESMO) Congress.

See: "Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer" Ronald de Wit et al. NEJM September 30, 2019 DOI: 10.1056/NEJMoa1911206