More good news for Roche’s blockbuster drug, MabThera (rituximab), which looks set to see its market broadened yet further after data showed it halved the risk of death in patients receiving maintenance therapy for a form of non-Hodgkin’s lymphoma.
The Swiss giant, which reaped in excess of 3 billion Swiss francs ($2.3 billion) for MabThera during the third quarter of this year alone, says it will today file a label extension for the drug in maintenance therapy with the European drug regulatory agency, the EMEA.
The dossier includes data from a two-year study involving patients with indolent NHL, presented at this week’s American Society of Hematology meeting in Atlanta, USA.
In this so-called EORTC trial, 465 patients with relapsed and refractory indolent NHL received either three-weekly treatment with conventional chemotherapy, or MabThera plus conventional chemotherapy, as induction therapy. Responding patients were then randomised again to either MabThera maintenance, or observation (no further treatment).
Results from the induction phase showed patients in the MabThera arm experienced a significantly higher rate of complete remission than patients who received conventional chemotherapy alone (29% versus 16%), as well as increased progression free survival of 33 months vs 20 months. And the results from the maintenance phase were equally impressive.
Overall survival (defined as the percentage of patients alive after three years) was 85% amongst those given maintenance therapy, compared to 77% who received no maintenance – a reduction in the risk of death of 48%, says Roche. In addition, median progression-free survival was 15 months in the no maintenance arm, compared to 52 months in patients receiving MabThera – a risk reduction of 60%.
Even for patients who had not received MabThera treatment initially, maintenance therapy with the drug boosted survival. Professor Marinus van Oers, lead investigator of the pivotal study said: "Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. We have not seen such an impressive improvement in progression free and overall survival for indolent NHL in the last 30 years. Maintenance therapy with MabThera may well become the new standard of care for these patients."
And Roche will be clearly hoping this is the case. MabThera is one of the stalwarts of its immensely successful oncology portfolio, and is also nearing the market in rheumatoid arthritis. In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, while around 40,000 are being treated for the disease.