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ZOLINZA (vorinostat) in combination with bortezomib demonstrated clinical activity
Date:12/8/2007

okinetic and pharmacodynamic activity of the combination regimen. Patients also were evaluated for response and tolerability.

The median age of patients in the study was 54 years (39-78) and the median number of prior therapies was 7 (range of 3-13), with 19 patients previously treated with bortezomib.

Results of the study showed that the MTD for the combination regimen was achieved at ZOLINZA 400 mg daily for 8 days plus bortezomib 1.3 mg/ m2 days 1, 4, 8 and 11 respectively. Forty-three percent of patients had a partial response or greater (1 VGPR and 9 PR) following treatment with the ZOLINZA and bortezomib combination regimen, assessed using the International uniform response criteria for multiple myeloma. Among the 19 patients previously treated with bortezomib, one achieved a very good partial response and six had a partial response. Two patients experienced dose-limiting toxicities (fatigue and prolonged QT interval). Some of the non-hematological toxicities grade 2 and higher included fatigue (n=9), nausea (n=6), vomiting (n=3), diarrhea (n=3), pneumonia (n=3, bacterial and RSV), shingles (n=2) and atrial fibrillation (n=1).

Based on these initial results presented for the first time, Merck is evaluating plans to accelerate testing of ZOLINZA in combination with bortezomib in the randomized clinical trial setting to further define the clinical activity in relapsed or refractory multiple myeloma," said Dr. Garcia-Vargas.


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Contact: Gina Juliano
gina_juliano@cohnwolfe.com
917-359-5521
Cohn & Wolfe
Source:Eurekalert

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