Published data from a Phase III study conducted by biopharmaceutical company Cephalon has shown that Treanda (bendamustine HCl) significantly improves the clinical outcome of patients suffering from chronic lymphocytic leukaemia (CLL).
In March 2008 Treanda became the first agent approved by the US Food and Drug Administration for CLL since 2001, based on the results of this study.
The results published in the Journal of Clinical Oncology demonstrated a significant improvement in overall response and progression-free survival in patients treated with Treanda when compared to chlorambucil.
During the Phase III randomised, international, multicentre, open-label study patients received Treanda or chlorambucil for up to six treatment cycles. Results showed that Treanda demonstrated significantly better outcomes for both primary endpoints compared to chlorambucil.
Patients in the Treanda treatment arm also had a higher complete response rate than those treated with chlorambucil, with some patients showing no sign of CLL in their blood.
Lead investigator of the study Wolfgang Knauf, Onkologische Gemeinschaftspraxis, Frankfurt, Germany said that CLL is the most common form of adult leukaemia in the Western world.
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“Because it is incurable, the goal of treatment is to stabilise the cancer over the long term by extending periods of remission,” Knauf said.
Treatment options are limited, but this study shows that bendamustine demonstrates significantly better efficacy compared to chlorambucil with a tolerable safety profile.
Treanda also showed an improvement in the duration of response compared to chlorambucil, by 21.8 months compared to eight months.
The most common adverse events included myelosuppression, fever, nausea, vomiting and diarrhoea.