AusPAR: Cabazitaxel - Therapeutic Goods Administration

AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4
Final 9 February 2012
Therapeutic Goods Administration
Table 7: Analysis populations - by study and treatment group (Phase III study EFC
6193 and Phase I/Phase II studies)
In study EFC 6193, a 25 mg/m 2 dose was chosen. In the two Phase I studies (TED 6188
and TED 6190) and the Phase II study of patients with metastatic breast cancer (ARD
6191), the dose ranged from 20 to 25 mg/m 2 every 3 weeks.
The median duration of treatment ranged from 6.4 weeks to 18.6 weeks. In the pivotal
study, the patients in the cabazitaxel arm received more cycles of study treatment (median
6 cycles) compared with the mitoxantrone arm (median 4 cycles). Dose reductions of >
20% were required in 9.8% of cycles in the cabazitaxel arm compared to 5.1% of cycles in
the mitoxantrone arm. The median relative dose intensity (RDI) was 96.12% for the
cabazitaxel arm and 97.25% for the mitoxantrone arm, suggesting that both arms were
equally able to receive their respective intended doses. In the Phase I/II studies the
median RDI for cabazitaxel 25 mg/m 2 was
95%. In the combination treatment study (TCD 6945), the median RDIs were 95.5% and
87.4% for cabazitaxel and capecitabine, respectively.
Adverse events
Treatment related adverse events (adverse drug reactions)
Pivotal study
In study EFC 6193, 95.7% of patients in the cabazitaxel arm and 88.4% of patients in the
mitoxantrone arm reported a treatment emergent adverse effect (TEAE). Grade > 3 TEAEs
were reported in 57.4% of the cabazitaxel arm and 39.4% of the mitoxantrone arm.
Serious TEAEs were reported in 39.1% of the cabazitaxel arm and 20.8% of the
mitoxantrone arm (Table 8).
Table 8: Brief summary of adverse events - safety population
The most common adverse events in both arms of the study were haematological adverse
events, which included neutropenia and febrile neutropenia. They were more prominent
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