Tanespimycin Phase 1b Trial Results
The objective of the Phase 1b dose-escalating trial was to define a Phase 2/3 dose of tanespimycin in combination with bortezomib in patients with relapsed, refractory multiple myeloma, as well as to assess pharmacokinetic and pharmacodynamic parameters. Dose escalations in the trial ranged from 100- 340 mg/m2 for tanespimycin, and from 0.7-1.3 mg/m2 for bortezomib. Patients received tanespimycin via 1-hour infusion following the bortezomib dose 2 times per week every 2 weeks out of 3 weeks.
Data on 56 patients enrolled in 7 dose cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib) were reported. Of the 28 patients enrolled in cohort 7 (340 mg/m2 tanespimycin, 1.3 mg/m2 bortezomib), 19 received the Cremophor formulation of tanespimycin and 9 patients received the new injectable suspension formulation of tanespimycin.
Of these 56 patients, all had received multiple prior chemotherapy regimens (median of 4), and 67% had received bone marrow transplants.
Responses were observed across dose cohorts in bortezomib-naove, pretreated and refractory patients (refractory is defined as having no response to prior bortezomib or having progressed on or within 60 days of their last dose of a bortezomib-containing regimen). Response rate in multiple myeloma is measured primarily by the level of myeloma (M) protein in the patient's bone marrow. In those patients who received a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response rate including complete, partial and minimal responses was 44% (18 out of 41 patients evaluable for response):
-- 8 out of 14 bortezomib-naive patients (57%); -- 7 out of 16 bortezomib-pretreated patients (44%); and -- 3 out of 11 bortezomib-refractory patients (27%). In the bortezomib-ref
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