Zolinza® (vorinostat)

What is Zolinza?

Zolinza (vorinostat) is a histone deacetylase (HDAC) inhibitor being developed by Merck. Some cancer cells display excess HDAC activity, which inhibits the expression of genes that regulate cell growth. In laboratory studies, Zolinza has been shown to inhibit cancer cell growth and to induce cell death.

Other names for Zolinza are SAHA (suberoylanilide hydroxamic acid) and MK0683. Zolinza is given once a day with food.

What do we know about Zolinza’s activity in myeloma?

Laboratory and animal studies show that Zolinza displays additive, and often synergistic, activity when combined with Velcade® (bortezomib), melphalan, or Revlimid® (lenalidomide) and dexamethasone.

Several phase I studies have been conducted with Zolinza in relapsed and/or refractory myeloma. Preliminary data show that:

• The combination of Zolinza and Velcade appears to be active over the long term, even in some patients who have previously received Velcade and stopped responding.
  • Results of another study evaluating this combination (n=23) showed an overall response rate of 42%, including 3 partial responses among 9 patients who were refractory to Velcade.
• The combination of Zolinza, Revlimid, and dexamethasone appears to be an active oral regimen that is well tolerated.

Preliminary results of a Phase IIb study evaluating Zolinza in combination with Velcade in patients with relapsed and refractory myeloma who had previously received Velcade show an encouraging response rate approaching 20% in this heavily-pretreated population. This trial is being facilitated by the Multiple Myeloma Research Consortium (MMRC).

How is Zolinza currently being studied in myeloma?

Zolinza is being studied in a number of clinical trials in relapsed and/or refractory myeloma, including:

• A Phase III trial in combination with Velcade
• A Phase II trial in combination with Velcade, which is being facilitated by the Multiple Myeloma Research Consortium (MMRC)
• A Phase I study in combination with Velcade and Doxil® (doxorubicin HCl liposome injection)
• Early data suggests that adding Zolinza to Velcade and Doxil is efficacious, and the toxicities manageable.
• A Phase I study in combination with Velcade

Zolinza is also being evaluated in newly diagnosed myeloma:

• A Phase I trial in combination with Revlimid, Velcade and dexamethasone

In addition, Zolinza is being evaluated as maintenance therapy in patients who have undergone autologous stem cell transplant:

• A Phase II trial in combination with Velcade
• A Phase I trial in combination with Revlimid

Click here to go to the MMRF Clinical Trial Matching Service.