Rituximab (MabThera, Rituxan) doubles survival of lymphoma patients: Roche

Continued use of rituximab (MabThera) at least for two years could double the survival of advanced follicular lymphoma, according to a new study by Roche.

Roche announced data from the phase III PRIMA study showing that continuing rituximab (MabThera) for two years in patients who responded to initial treatment with MabThera plus chemotherapy, doubled the likelihood of them living without their disease worsening, known as progression-free survival (PFS), compared to those who did not receive maintenance.

The study enrolled patients with previously untreated advanced follicular lymphoma. No new safety signals were observed in this study and the safety profile was consistent with previous experience with MabThera.

“Follicular lymphoma is an incurable cancer that may return many times during a person’s life and require additional therapy,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche.

After two-years of follow-up, 82 percent of patients who received MabThera maintenance were in remission compared to 66 percent of patients who did not.

Follicular lymphoma is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about one in five of all cases.

It can occur at any time during adulthood, though people are typically diagnosed during their sixties, and affects as many men as it does women.

It is a low-grade lymphoma, which means that it usually develops slowly.

Approximately 286,000 people worldwide are diagnosed with non-Hodgkin lymphoma each year.

Sponsored by the Group d’Etudes de Lymphomes de L’Adulte (GELA), PRIMA is an international, multicenter, randomized, Phase III clinical study that enrolled 1,217 patients with previously untreated advanced follicular lymphoma.

In the study, MabThera plus either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone) or FCM (fludarabine, cyclophosphamide, mitoxantrone) chemotherapy was used as initial treatment.

Patients who responded were randomized to receive MabThera alone, given once every two months for two years (maintenance), or observation alone.

The safety profile was consistent with those previously reported in pivotal studies of MabThera alone or in combination with chemotherapy.

What is rituximab (MabThera)?

MabThera is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera is indicated in the EU for the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy; only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.

Rituximab (MabThera) is also used for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy and as maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera.

In addition, in rheumatology MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

MabThera is known as Rituxan in the United States, Japan and Canada. Across labelled indications, over 2.1 million patient exposures with MabThera have been recorded worldwide since launch, among which almost 1.9 million in hematological malignancies.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Headquartered in Basel, Switzerland, Roche has combined strengths in pharmaceuticals and diagnostics.

Roche is the world’s largest biotech company with medicines in oncology, virology, inflammation, metabolism and CNS.

Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.