Sanofi-aventis Presents Cabazitaxel Updated Phase 3 Results
Sanofi-aventis has updated results from the Phase 3 trial, Tropic, that demonstrated the investigational drug cabazitaxel plus prednisone/prednisolone, significantly improved overall survival, versus an active chemotherapy combination of mitoxantrone plus prednisone/prednisolone, in patients with metastatic hormone-refractory (castrationresistant) prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy.
Updated results of the primary end point (overall survival) showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 28% [HR=0.72 (95% CI: 0.61-0.84); P<0.0001] with an improvement in the median overall survival of 15.1 months vs. 12.7 months in the mitoxantrone combination arm.
According to the Sanofi-aventis, the most frequent grade 3/4 hematological adverse events with cabazitaxel were neutropenia (81.7%) assessed by laboratory values, leukopenia (68.2%), anemia (10.5%), and febrile neutropenia (7.5%); the most frequent grade 3/4 non-hematological adverse events were diarrhea (6.2%), fatigue (4.9%), and asthenia (4.6%).
Discontinuation of treatment due to adverse events occurred in 18.3% of patients in the cabazitaxel arm and 8.4% of patients in the mitoxantrone arm. Most frequent treatment-emergent adverse events leading to discontinuation in the cabazitaxel arm were neutropenia (2.4%), hematuria (1.3%), diarrhea (1.1%) and fatigue (1.1%).
Grade 3/4 peripheral neuropathy occurred in 0.5% of patients in the cabazitaxel arm vs. 0.3% in the mitoxantrone arm. Deaths due to adverse events were 4.9% in the cabazitaxel arm (predominantly due to neutropenia and its complications) vs. 1.9% in the mitoxantrone arm.
Marc Cluzel, executive vice-president of research and development at Sanofi-aventis, said: "It is impressive to see the updated results continue to demonstrate an improvement in overall survival compared with that achieved with a standard chemotherapy regimen. These are encouraging results in a difficult-to-treat stage of prostate cancer."
Debasish Roychowdhury, senior vice president of global oncology at sanofi-aventis, said: "The development of cabazitaxel is one of many investigational compounds we hope to present to the cancer community in the months and years to come."