Board Recommends Continuation of Phase IIb Study of Vorinostat

Merck & Co., Inc. announced that an independent Data Safety and Monitoring Board recommended the continuation of VANTAGE 95, a Phase IIb clinical study of the investigational use of vorinostat in combination with bortezomib in patients with late-stage relapsed or refractory multiple myeloma who were refractory to bortezomib.

Vorinostat (marketed as ZOLINZA) is an oral histone deacetylase (HDAC) inhibitor manufactured by Merck and currently is indicated only for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. The efficacy and safety of vorinostat for the treatment of cancers other than cutaneous T-cell lymphoma (CTCL) has not been established.

“This is a unique study in a patient population that has exhausted all other currently available treatment options,” said Eric Rubin, M.D., vice president, oncology clinical research, Merck Research Laboratories. “We are pleased that the DSMB has recommended continuing the investigation of vorinostat for the treatment of late-stage relapsed or refractory multiple myeloma, and we look forward to completing enrollment for VANTAGE 95.”

Date: February 8, 2010
Source: Merck