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news.Wyeth Pharmaceuticals, a division of Wyeth, has announced positive results of a three-arm Phase III clinical trial that show patients with relapsed or refractory mantle cell lymphoma, treated with the mTOR inhibitor Torisel experienced a statistically significant improvement in median progression-free survival, compared with single-agent therapy selected by the investigator.
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This three-arm, open-label, randomized, Phase III trial compared two different dose regimens of Torisel with investigators’ choice of therapy (IC) in patients with relapsed or refractory mantle cell lymphoma 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 175mg for three successive weekly doses followed by 75mg IV weekly; Torisel 175mg IV for three successive weekly doses followed by 25mg 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 endpoint was progression-free survival (PFS) based on independent review. Secondary endpoints were objective response rate and overall survival.
Median PFS for patients treated with Torisel 175mg/75 mg was 4.8 months, compared with 1.9 months for patients treated with IC. In the Torisel 175 mg/25mg arm, median PFS was 3.4 months, but this difference was not statistically different from IC (P=0.0618). Patients receiving Torisel 175 mg/75mg showed a nonsignificant trend toward longer overall survival than those treated with IC (13.6 months versus 9.7 months; HR=0.80). Torisel 175mg/75 mg led to a statistically significant improvement over IC in objective response rates (22% versus 2%, P=0.0019).
Joseph Camardo, senior vice president of global medical affairs at Wyeth Pharmaceuticals, said: “These findings reinforce the clinical potential of mTOR inhibition with Torisel. Wyeth is committed to the continued exploration of mTOR inhibition with Torisel for the treatment of a variety of cancers.”