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The Role of mTOR in Cancer Etiology and Treatment Based on presentations from the

The Role of mTOR in Cancer Etiology and Treatment Based on presentations from the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) May 30-June 3, 2008 Chicago, Illinois. Study Design. MCL confirmed locally Relapsed/refractory to 2-7 prior therapies Required:

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The Role of mTOR in Cancer Etiology and Treatment Based on presentations from the

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  1. The Role of mTOR in Cancer Etiology and Treatment Based on presentations from the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) May 30-June 3, 2008 Chicago, Illinois

  2. Study Design • MCL confirmed locally • Relapsed/refractory to • 2-7 prior therapies • Required: • Rituximab • Anthracycline • Alkylating agent Temsirolimus 175 mg q3w then 75 mg qw Temsirolimus 175 mg q3w then 25 mg qw RANDOMIZATION Investigator’s choice single agent* Temsirolimus treatment to continue until progression, death or unacceptable toxicity *Protocol specified (n): Gemcitabine i.v. (22), fludarabine i.v., oral (14), chlorambucil oral (3), cladribine i.v. (3), etoposide i.v. (3), cyclophosphamide oral (2) *Approved additions (n): Thalidomide oral (2), vinblastine i.v. (2)alemtuzumab i.v. (1), lenalidomide oral (1) Adapted from Hess et al. ASCO 2008, abstract 8513.

  3. Dose Administration and Exposure Adapted from Hess et al. ASCO 2008, abstract 8513.

  4. Progression-free Survival (ITT) Excluding Patients with Blastoid Histology Adapted from Hess et al. ASCO 2008, abstract 8513.

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