Basel, 8 December 2009
MabThera/Rituxan is the first treatment to show improved overall survival in previously untreated patients with chronic lymphocytic leukemia
Updated study results show patients live longer than when treated with chemotherapy alone
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with MabThera/Rituxan (rituximab) compared to chemotherapy alone.
“Treatment with rituximab in the CLL8 randomized study has shown for the first time that a specific first-line treatment for CLL could improve overall survival”, said Professor Michael Hallek, University of Cologne, Germany, who led the CLL8 trial for the German CLL Study Group (GCLLSG). “The results support the recommendation to use fludarabine, cyclophosphamide and rituximab (FCR) as standard therapy in physically fit patients with CLL”.
New data from the Phase III CLL8 study showed that 87.2 percent of patients with previously untreated CLL who received MabThera/Rituxan plus FC were alive after more than three years of follow up compared to 82.5 percent of patients who received FC alone (p=0.012). The median survival has not yet been reached. After more than three years of follow up, patients who received MabThera/Rituxan plus FC had a median progression-free survival (PFS) of 51.8 months compared to 32.8 months for those who received FC alone. No new safety signals were observed in CLL8 and safety was consistent with previous MabThera/Rituxan experience.
“With these new data, MabThera/Rituxan is now proven to offer patients suffering from this incurable disease the very real hope of living longer”, said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “It once again illustrates the ongoing potential shown by MabThera/Rituxan in changing the treatment patterns of chronic diseases like CLL”.
The CLL8 study is an international study conducted by the German CLL Study Group and Professor Michael Hallek (Cologne, Germany) in collaboration with Roche. It included 817 patients with CLL receiving first-line treatment. The study was conducted at 191 study sites across 11 countries. In this randomized study, patients received either MabThera/Rituxan in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The results showed that median PFS for patients receiving Rituxan/MabTherain combination with chemotherapy as first-line treatment lived an average ofwas 42.80 months without their cancer progressing compared to an average of 32.3 months for patients receiving chemotherapy alone (hazard ratio 0.56, p=0.0001). With the Rituxan/MabThera combination, at two years, more than three quarters (76.6%) of previously untreated patients were disease-free compared to 63.3% patients treated with chemotherapy alone. Also importantly, complete response rate at end of treatment was almost doubled with the Rituxan/MabThera chemotherapy combination compared to chemotherapy alone (22.9% vs 44.5%, p<0.01). The primary endpoint of the study was progression-free survival. No new or unexpected safety signals were observed.
The results of CLL8 were first presented in 2008 and showed that patients receiving MabThera/Rituxan in combination with chemotherapy as first-line treatment lived an average of 40 months without their cancer progressing compared to an average of 32 months for patients receiving chemotherapy alone.
MabThera/Rituxan 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/Rituxan is indicated in the EU:
- For the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with 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/Rituxan
- For the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma (NHL) 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 oncology, MabThera/Rituxan is indicated in the US:
- For the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- For the treatment of NHL for the following:
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (or other anthracycline-based chemotherapy regimens)
In addition, in rheumatology MabThera/Rituxan 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. Over 1.9 million patient exposures with MabThera/Rituxan have been recorded worldwide since its launch.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan 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 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 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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