Monday, December 11, 2006

Roche presents yet more promising data on MabThera

Roche presents yet more promising data on MabThera - 11/12/2006

Roche has unveiled long-term data showing that its antibody drug MabThera, when given as a first-line therapy, prolongs survival for patients suffering from advanced follicular non-Hodgkin's lymphoma.

The Phase III study of 321 patients, presented at the American Society of Hematology meeting in Orlando shows that MabThera (rituximab), in combination with cyclophosphamide, vincristine and prednisolone (CVP) increased overall survival at four years, with 81% patients treated with rituximab and chemotherapy still alive compared with only 71% on chemotherapy alone.

In addition, patients in the investigative arm saw a significantly extended time to disease progression or death of 34 months compared with 15 months for patients receiving CVP alone. This meant estimated disease-free survival at four years was 54% for patients given the four drug regimen, versus 17% for those on CVP, says the firm.

Lead investigator of the study, Dr Robert Marcus of Addenbrookes Hospital, Cambridge, said that the data demonstrating "a modest but definite improvement in overall survival are encouraging" and suggests the addition of rituximab to CVP confers long-term benefit.

MabThera, sold in North America and Mexico by Roche's partner Genentech as Rituxan, is an integral part of the firm's cancer portfolio, along with Herceptin (trastuzumab) and Avastin (bevacizumab). MabThera is one of the star's in Roche's pipeline and is helping to drive growth - having pulled in a whopping 2.3 billion swiss francs ($1.9 billion) during the first half of this year alone. And the Swiss firm clearly sees additional potential in the compound, which has shown promise in various other indications, notably rheumatoid arthritis and multiple sclerosis.

In Europe, MabThera is approved as maintenance therapy for patients with relapsed or refractory follicular Non-Hodgkin's lymphoma, as first-line treatment of both aggressive and indolent NHL (in combination with chemotherapy), as a second-line monotherapy for indolent NHL, and for rheumatoid arthritis.

Xeloda meets survival endpoint
Meantime Roche noted that its latest Phase III study of oncology drug
Xeloda (capecitabine) with 627 previously-reated patients with advanced
colorectal cancer met its primary endpoint of progression-free survival.

Study results showed that the chemotherapy combination Xelox - oral Xeloda plus oxaliplatin - was as effective in delaying disease progression as the chemotherapy combination Folfox-4 (infused 5-FU/leucovorin plus