I have written a lot about two developmental, anti-myeloma drugs here recently, carfilzomib and pomalidomide. But there are a number of other new, experimental drugs on the horizon.
One of these, vorinostat, looks expecially promising. Vorinostat is being developed by Merck Oncology. Vorinostat doesn’t do much to fight multiple myeloma on it’s own. But early combination studies confirm that vorinostat enhances and improves the response a patient has to Velcade or Revlimid. Vorinostat is already used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells. Vorinostat’s trade name is Zolinza.
I spent a great deal of time researching vorinostat at the ASH meetings last December in New Orleans. There I spoke with Dr. Kenneth Anderson, an acknowledged multiple myeloma expert from the Dana-Farber Cancer Institute in Boston, about vorinostat’s potential.
Dana-Farber is hosting several clinical studies involving vorinostat, and Dr. Anderson is actively involved with vorinostat’s development.
Dr. Anderson is a quiet, unassuming man. He usually speaks softly in a careful, measured way. But Dr. Anderson became visably excited when he discussed vorinostat.
I was so impressed that I looked into joining a new, vorinostat study. I didn’t qualify at the time, but I may soon–now that my multiple myeloma is creeping back. Like most other new, myeloma related drugs, vorinostat is initially being tested on relapsed and/or refractory patients. In other words, patients like me who’s multiple myeloma has returned.
With the help of Ali Kresge from Merck Oncology, I recently had the opportunity to conduct an e-mail interview about vorinostat with Dr. Eric Rubin, Vice President of Merck.
I concentrated on the clinical study aspect during the first part of our interview:
I understand Zolinza (vorinostat) is currently FDA approved for use in relapsed patients with cutaneous T-cell lymphoma (CTCL). I also know Zolinza is currently in clinical trials for use against multiple myeloma. I have also heard Zolinza is doing quite well in several of these studies. How many ongoing multiple myeloma centered clinical trials involve Zolinza?
We have several studies ongoing investigating the efficacy of Zolinza (vorinostat) in treating several different forms of cancer. For a complete list of trials, visit http://www.clinicaltrials.gov/ct2/results?term=vorinostat. In regards to multiple myeloma specifically, Merck has two registration trials, titled VANTAGE 088 and VANTAGE 095, in addition to several investigator-sponsored and NCI trials detailed on http://www.clinicaltrials.gov/ct2/results?term=vorinostat+multiple+myeloma). Below are VANTAGE 088 and VANTAGE 095 trial details.
– VANTAGE 088 is a randomized, placebo-controlled Phase III trial that will enroll nearly 750 patients at more than 35 centers worldwide. Eligible patients must be 18 years or older, have a diagnosis of multiple myeloma, and have received at least one (but no more than three) prior treatment regimens. Patients who have previously received bortezomib therapy must have experienced a complete, partial or minimal response and not be considered refractory to bortezomib. The study will compare progression-free survival in patients taking bortezomib with either Zolinza or placebo. Overall survival, time to progression, objective response rate and tolerability will also be assessed.
– VANTAGE 095 is an open-label Phase 2b study that will enroll approximately 150 patients at more than 13 sites worldwide. Eligible patients must be at least 18 years or older, have a diagnosis of multiple myeloma, and have had at least two prior courses of treatment. In addition, patients must be refractory to bortezomib taken alone or in combination with other anti-myeloma therapies, such as thalidomide or lenalidomide. The study will assess objective response rate, as well as progression-free survival, overall survival, time to disease progression and tolerability.
Vantage 95 has just completed enrollment, but VANTAGE 088 is still recruiting. Eligible patients are encourage to call 888-577-8839 or visit merckcancertrials.com to learn more.
Are there any pending trials?
The postings on http://www.clinicaltrials.gov/ct2/results?term=vorinostat+multiple+myeloma reflect all current clinical trials being undertaken at this time in regards to Zolinza.
I will pass along the second part of our interview tomorrow.
Feel good and keep smiling! Pat