Media Release

Basel, 20 May 2010

Phase III study showed first-line maintenance use of MabThera doubles likelihood of people with follicular lymphoma living without their disease worsening

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III PRIMA study. The data showed that continuing MabThera (rituximab) 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.

The data were featured during an American Society of Clinical Oncology (ASCO) presscast today. The organization’s 46th Annual Meeting will take place from June 4 – 8, 2010 in Chicago, with more detailed PRIMA results presented on Saturday, June 5.

“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. “The study is important because in those people who continued MabThera, the risk of the cancer progressing was cut in half compared to those who did not receive maintenance MabThera.”

Results of the PRIMA study showed MabThera, when used as maintenance, doubled the likelihood of people with follicular lymphoma living without their disease worsening compared to those who stopped 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.

Roche and Genentech recently submitted an extension of the MabThera Marketing Authorization Application to the European Medicines Agency (EMEA) and a sBLA (supplemental Biologics License Application) for Rituxan to the U.S. Food and Drug Administration (FDA) based on the PRIMA study data.

“These findings provide hope for the way we manage follicular lymphoma. MabThera maintenance therapy is likely to become a new standard of care for these patients,” said Prof. Gilles Salles, Centre Hospitalier Lyon Sud, France and principal investigator for the PRIMA trial.

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.1 Approximately 286’000 people worldwide are diagnosed with non-Hodgkin lymphoma each year.2

About PRIMA

PRIMA abstract will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago:

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) – Saturday, June 5, 2010, 1:00 p.m. – 1:15 p.m. CST, Room E354a

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. 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 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 those previously reported in pivotal studies of MabThera alone or in combination with chemotherapy. Serious 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).

About 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.

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 therapy 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 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.

About Roche

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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References:
1) http://www.cancerbackup.org.uk/Cancertype/Lymphomanon-Hodgkin/TypesofNHL/Follicular
2) http://www.lymphomacoalition.org