In anticipation of our Monday night teleconference on Provenge (see below for registration procedures) I am very happy to report that Dendreon is now detailing plans to move Provenge to earlier stages in the disease’s progress.
At the American Society of Clinical Oncology (ASCO) meeting in Chicago which is winding down today, Dendreon unveiled plans for three earlier stage clinical trials, two targeting advanced prostate cancer. This is great news for many of us.
Provenge was approved last year by the FDA for use with men with castrate resistant disease, but many people have been clamoring for its use in earlier stages of advanced prostate cancer. Provenge uses a man’s own white blood cells to stimulate the body’s immune system to fight cancer. In the clinical trials leading up to its approval Provenge demonstrated a survival advantage of approximately 4.2 months over placebo.
According to Mark Frohlich, Dendreon’s chief medical officer, “We weren’t able to take it to the next step….. It is no surprise that we were resource constrained until we had positive data from the trial, and we’ve had large commercial launch activities going on.” Dendreon is no longer resource constrained as they recently received FDA approval for thirty additional work stations and on June 30th Dendreon is anticipating a positive word from the FDA that would allow them to put on-line their new plant in Atlanta, Georgia. In addition to these two plants in the near future they are scheduled to complete construction on a plant located in the west coast of the United States.
The new main planned trial is designed to look at earlier use of the drug, in men who are still hormone responsive. They are anticipating having a sample size of approximately 1,700 men in this trial.
“We hope that the earlier you bring in the treatment, the longer that survival read out may be,” said Thomas Powles, co-chief investigator in the study and oncologist at St. Bartholomew’s Hospital in London. “You want to give this therapy to patients when their immune repertoire is functioning at its best,” he said. Provenge isn’t available in Europe yet–Dendreon plans to submit for European approval later this year or early next year.
That trial is anticipated to begin by year-end, while men should begin enrolling in the wider trial in early 2012. The larger trial should take three to four years to fully enroll. Since the trial will measure overall survival its duration will ultimately depend on when patients die, however, the trial will include an interim analysis. Since we know that men with advanced prostate cancer often can still live for 5 to 10 years the trial will take a long time to be completed, hopefully the interim results will be so positively dramatic that the trial will be ended early.
In another planned trial Dendreon is planning on evaluating men with a rising PSA to see if they would benefit from Provenge before or after getting hormone therapy. This trial will measure the immune response in the two group, and the data will likely be used to help design a larger Phase III study.
A third trial is a long-planned mid-stage study of a drug that works similarly to Provenge but targets a protein, called HER2/NEU, on the surface of some cancer cells. The trial tests the drug in bladder cancer, in the 50% of patients whose disease has the protein marker. The collected data also will be used for planning a larger trial.
Bottom line, we will soon see the launching of vital new trials that will hopefully usher in the use of Provenge at earlier stages and with hopefully even larger survival benefits.
Joel T Nowak, M.A., M.S.W.
About Malecare’s Teleconference:
Malecare Cancer Support’s Advanced Prostate Cancer Program invites you to our teleconference on Provenge.
The free Teleconference will begin 6PM EDT, Monday, June 13, 2011. Please register at http://bit.ly/kKuByH Call in number and code will be emailed to you, along with info on how to ask your specific question of our guest.
Joel Nowak, MSW, Director of Malecare Advanced Disease and Advocacy will be speaking with Neal Shore, MD. Dr. Shore is affiliated with the Carolina Urologic Research Center, Linked Urology Research Network and Uropath and is a leading urologist in using Provenge on advanced prostate cancer.
Malecare Cancer Support is our country’s largest men’s cancer survivor support and advocacy national nonprofit organization. Malecare produces research, informational materials, and online and in-person support groups throughout the United States. Malecare also facilitates the only national support program for men presenting with advanced prostate cancer. This teleconference is part of that program.
Visit malecare.org for more information on prostate cancer.
Malecare Cancer Support services are free and open to all.