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New Data Show TORISEL Improves Progression-Free Survival for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Date:5/31/2008

mTOR inhibitor approved to treat RCC. TORISEL specifically inhibits the mTOR kinase, an important regulator of cell proliferation, cell growth and cell survival and is the only renal cancer therapy proven to extend median overall survival compared with interferon-alpha in patients with advanced RCC.

Study Design and Results

This three-arm, open-label, randomized, phase 3 trial compared two different dose regimens of TORISEL with investigators' choice of therapy (IC) in patients with relapsed or refractory MCL who had received two to seven prior therapies, which could include hematopoietic stem cell transplantation. Patients were randomly assigned to receive intravenous (IV) TORISEL at 175 mg for three successive weekly doses followed by 75 mg IV weekly; TORISEL 175 mg IV for three successive weekly doses followed by 25 mg IV weekly; or investigators' choice of one of the following single agents at predefined doses: gemcitabine, fludarabine, chlorambucil, cladribine, etoposide, cyclophosphamide, thalidomide, vinblastine, alemtuzumab or lenalinomide. The primary end point was PFS based on independent review. Secondary end points were objective response rate and overall survival.

Median PFS for patients treated with TORISEL 175 mg/75 mg was 4.8 months, compared with 1.9 months for patients treated with IC. In the TORISEL 175 mg/25 mg arm, median PFS was 3.4 months, but this difference was not statistically different from IC (P=0.0618).

Patients receiving TORISEL 175 mg/75 mg showed a nonsignificant trend toward longer overall survival than those treated with IC (13.6 months vs. 9.7 months; HR=0.80). TORISEL 175 mg/75 mg led to a statistically significant improvement over IC in objective response rates (22 percent vs. 2 percent, P=0.0019).

The most frequently occurring grade 3 or 4 adverse events among patients treated with TORISEL 175 mg/75 mg, TORISEL 175 mg/25 mg, or IC were thrombocytopenia (59 percent vs. 52 percent vs. 36 percent
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SOURCE Wyeth Pharmaceuticals
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