Basel, 24 September 2010
MabThera receives CHMP positive opinion in Europe for first line maintenance treatment of follicular lymphoma, a common type of blood cancer
Prolonged treatment with MabThera protects patients with follicular lymphoma from their disease getting worse.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the use of MabThera (rituximab) as maintenance treatment for people suffering from follicular lymphoma who have responded to induction therapy. Approval would expand treatment options for people with this common type of incurable blood cancer to help keep their disease under control for longer.
The recommendation is based on the results of the PRIMA study which showed that continuing MabThera for two years (maintenance treatment) in patients who responded to initial treatment with MabThera plus chemotherapy doubled the likelihood of these patients living without their disease worsening, known as progression-free survival (PFS), compared to those who did not receive maintenance treatment (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64; p=<0.0001). 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.i
The benefit of maintenance treatment was seen across all major patient groups analysed within the trial regardless of their tumour burden, age, gender or their response to initial treatment. The PRIMA data were presented at the American Society of Clinical Oncology (ASCO)’s 46th Annual Meeting in Chicago in June 2010.
“Receiving a positive opinion from the CHMP is another important step forward for people suffering from follicular lymphoma”, said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. "We believe that the major benefit observed for patients receiving MabThera maintenance therapy will change the way follicular lymphoma is treated."
Follicular lymphoma is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about one in four cases of NHL.i Follicular lymphoma can occur at any time during adulthood, though people are typically diagnosed during their sixties, and it affects as many men as it does women. It is a low-grade lymphoma which means that it usually grows slowly.ii Approximately 286’000 people worldwide are diagnosed with non-Hodgkin’s lymphoma each year.iii
Based on the PRIMA study data, Genentech also recently submitted a sBLA (supplemental Biologics License Application) for MabThera in March 2010 (known as Rituxan in the United States, Japan and Canada) to the U.S. Food and Drug Administration (FDA).
Sponsored by the Groupe d'Etude des Lymphomes de l'Adulte (GELA), PRIMA is an international, multicenter, randomised, Phase III clinical study that enrolled 1’217 patients with previously untreated advanced follicular lymphoma. The study evaluated the efficacy and safety profile of maintenance MabThera in patients who responded to initial treatment with MabThera plus chemotherapy (induction treatment).
In the PRIMA 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 (1’018/1’217) were randomized to receive MabThera alone, given once every two months for two years (maintenance), or observation alone.
The safety profile was consistent with that previously observed in pivotal studies of MabThera alone or in combination with chemotherapy. Adverse events (Grade 3 or 4) were reported in 23 percent of patients who received MabThera maintenance compared to 16 percent who did not, including low white blood cell (neutrophil) counts (4 percent vs. 1 percent) and infections (4 percent vs. <1 percent).
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.
In oncology, 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
- For the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
- As maintenance treatment for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera
- For the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy
- As monotherapy for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy
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 to initial anti-TNF therapy. MabThera offers a superior clinical response over a second anti-TNF.
MabThera is known as Rituxan in the United States, Japan and Canada. Over 2.1 million patient exposures with MabThera have been recorded worldwide since launch, 2.0 million in haematological 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 is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated 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’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group 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. For more information: www.roche.com.
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i Salles, G. et al PRIMA: Rituximab Maintenance For Two Years Significantly Improves the Outcome of Patients With Untreated High Tumor Burden Follicular Lymphoma After Response to Immunochemotherapy: Results of the PRIMA Study: Abstract #8004; 46th Annual Meeting of the American Society of Clinical Oncology, 2010.