A Cancer Research UK funded UK Phase III trial of MabThera, combined with chemotherapy in the treatment of newly diagnosed patients with Mantle Cell Lymphoma (MCL), has shown considerably increased survival by at least eight months.
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MabThera, a monoclonal antibody, targets the cancerous white blood cells by identifying a protein on their surface known as CD20 and causes the destruction of these cells.
In the NCRN trial, newly diagnosed patients with MCL received up to eight cycles of oral FC (Fludarabine 40mg/m2 and Cyclophosphamide 250mg/m2) given every four weeks with a randomisation to the addition of MabThera 375mg/m2.
The study showed that people who received the combination of MabThera and chemotherapy experienced a 46% reduction in the risk of the disease worsening, compared to people who received chemotherapy alone.
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In the MabThera and chemotherapy arm, the overall response rate (ORR) was 87.5% and the average survival rate was 45.7 months, compared to 78.2% and 37.4 months respectively in the chemotherapy arm.
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By GlobalDataThe primary objective of the study was overall survival (OS), while the secondary objectives included progression free survival (PFS).
Patients in the trial experienced a median PFS benefit of an additional 13.9 months without their disease worsening, which was almost double that achieved with chemotherapy alone, with nearly 90% of participants responding to the treatment versus 78% in the chemotherapy arm.
Derriford Hospital, Plymouth, consultant hematologist and lead investigator of the trial Simon Rule said the findings from the study show an overall survival benefit to newly diagnosed MCL patients.
"The strategy of using MabThera in combination with chemotherapy provides the hope of extending life for more patients than has ever been achieved before with this potentially fatal disease," Rule added.
The study also demonstrated that people who received the combination of MabThera and chemotherapy experienced a 46% reduction in the risk of the disease worsening, compared to people who received chemotherapy alone.
Caption: Micrograph showing mantle cell lymphoma in a biopsy of the terminal ileum.
