Roche Pharmaceuticals

MabThera Maintenance Therapy Helps Non-Hodgkin's Lymphoma Patients Live for Years Longer Without Their Disease Progressing

    Basel, Switzerland (ots/PRNewswire) -

    - For non-US and non-UK Media Only

    - Long-term Results From a Phase III Study Highlight the Beneficial Role of MabThera in Patients With Recurrent or Resistant Disease

    Data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) today confirmed that patients with recurrent or resistant follicular non-Hodgkin's lymphoma (NHL) receiving MabThera maintenance therapy after initial treatment with (immuno) chemotherapy live almost 2.5 years longer without their disease progressing than those not receiving maintenance treatment, representing a threefold increase in progression-free survival time.

    Six-year follow up results from a study conducted by the European Organisation for Research and Treatment Cancer (EORTC) study group, show that patients with recurrent or resistant follicular NHL who were given MabThera maintenance treatment after their initial treatment with (immuno) chemotherapy had a median response of 3.7 years compared to 1.3 years for those who did not receive maintenance treatment. The results also indicate that patients treated with MabThera in combination with chemotherapy experience better complete response (CR) rates compared to patients treated with the chemotherapy combination cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) alone (29% vs 16%).

    "These results show that MabThera maintenance therapy can help patients with follicular NHL return to their 'normal' daily activities by offering years of extra time between relapses", said Professor Marinus van Oers of the University of Amsterdam and lead investigator of the study. "This is an important advance in the treatment of this still incurable form of NHL that will be welcomed by patients and physicians alike," he added.

    NHL affects one million people worldwide. Follicular NHL, representing about 25% of patients, is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable.

    About the study

    EORTC 20981 is a phase III study designed to evaluate the role of MabThera in the treatment of patients with relapsed and refractory follicular NHL during the induction and maintenance phases. It provides a six-year follow up of the study that was originally published in Blood in November 2006. At that time the median follow up had been 33 months. The primary endpoints were response rate for the induction phase and progression-free survival (PFS) for the maintenance phase. The study involved 465 patients during the induction phase (234 R-CHOP; 231 CHOP) and 334 patients during the maintenance phase (167 R; 167 observation). The results show that patients treated with MabThera and CHOP induction therapy experience better complete response (CR) rates compared to patients treated with CHOP alone (29% vs 16%). In addition, the results show that patients treated with MabThera during the maintenance phase experience improved PFS compared to patients observed (median 3.7 years vs 1.3 years). While improved PFS with MabThera does not translate into statistically significant overall survival advantages, this may be explained by the fact that 41% of patients received MabThera as (part of) salvage therapy. MabThera maintenance was also associated with a significant increase in grade 3/4 infections (9.7 % vs 2.4 %). Only 4 % of patients had to discontinue maintenance because of toxicity (mostly recurrent infections).

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@@start.t1@@      Further Information:
      - Roche in Oncology:
         http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
      - Lymphoma: http://www.lymphoma-net.org
      - The Lymphoma Coalition: http://www.lymphomacoalition.org
      - Cancer: http://www.health-kiosk.ch/start_krebs.htm
      - World Health Organization: http://www.who.int
      For more information, please contact:
      Peter Bayliss
      Roche
      Mobile: +41-7957-25193
      Email: peter.bayliss@roche.com
      Amber Bradbury
      Ketchum
      Phone: +44-7793-681615
      Email: amber.bradbury@ketchum.com@@end@@

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For more information, please contact: Peter Bayliss, Roche, Mobile:
+41-7957-25193, Email: peter.bayliss@roche.com; Amber Bradbury,
Ketchum, Phone: +44-7793-681615, Email: amber.bradbury@ketchum.com



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