Trial of MabThera in patients with Non Hodgkin’s Lymphoma

Investigational randomised data demonstrate potential of early and extended MabThera (rituximab) use to delay disease progression in patients with indolent Non Hodgkin’s lymphoma. Long-term data demonstrate 81% of patients remain free of disease five years after treatment with MabThera and CHOP chemotherapy.

December 9 2002, Philadelphia, USA

Genentech, IDEC Pharmaceuticals Corporation and Roche announced recently results from an investigational, randomised, multi-center study of MabThera, demonstrated that extended therapy with single-agent MabThera reduced the risk of disease progression or relapse by 55% for responding patients and nearly doubled event-free survival for chemotherapy-naive indolent non-Hodgkin’s lymphoma patients. The study was presented at the 44th Annual American Society of Hematology (ASH) meeting.

For previously-untreated patients with indolent NHL, the potential ability of additional maintenance doses of MabThera therapy to prolong disease- and treatment-free remission by as much as 17 months without additional toxicity is especially noteworthy.

Extended Therapy with Single Agent Rituxan

Professor Michele Ghielmini from the Swiss Group for Clinical Cancer Research presented data from the randomised, multi-center extended therapy single agent MabThera study in patients with indolent NHL.

The study involved 185 eligable patients. 57 patients had received no prior therapy and 128 patients had received some form of prior chemotherapy for NHL. All patients received an induction course of MabThera (375mg/m2 weekly for 4 weeks). The overall response rate to induction therapy was 67% for chemotherapy-naive patients and 46% for those with relapsed disease.

At week 12, 80% patients who achieved either a complete response or a partial response, or experienced stable disease from an initial course of MabThera were randomised to receive either extended therapy with MabThera (one dose 375mg/m2 at months 3,5,7,9 for a total of four doses) or were observed and did not receive treatment.

After a median of 35 months follow-up, the primary endpoint of event-free survival was 23 months in patients receiving extended therapy compared to 12 months for patients who did not receive extended therapy and were observed and greater in chemotherapy-naive patients with 36 months for patients receiving extended MabThera therapy compared to 19 months for patients who were observed. For responding patients at week 12, one year remission rates were 56% for patients in the observation arm and 80% for patients who received extended MabThera therapy.

Following the induction therapy, 34 patients improved the quality of their response with the complete response rate increasing from 10% at time of randomisation, to 23% at one year and 29% at further follow-up.

There was no clinically significant increase in adverse events or infections for patients receiving extended MabThera therapy compared to the observation control arm.

Long-Term Follow-Up of Rituxan plus Chemotherapy in Aggressive NHL

Julie Vose of the University of Nebraska, presented five-year follow-up data from a Phase II study of MabThera plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy in aggressive front-line NHL. Patients received six cycles of both Rituxan (375 mg/m2) and CHOP.

The initial analysis reported a 97% overall response rate, with 61% of patients experiencing a complete response and 36% having a partial response to therapy. At 26 months median follow-up, 91% were alive and 88% were free of disease progression. Now at a median follow-up of an additional three years, 88% of patients remain alive and 81% are free from disease progression.

This study adds to the growing body of investigational data evaluating MabThera plus CHOP chemotherapy in previously-untreated or front-line patients, demonstrating the potential ability to provide durable long-term remissions in both aggressive and indolent NHL, as well as increase overall survival.

For more information on Mabthera, go to the Pharmacy Department of Virtual Cancer Centre.