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ROCHESTER, Minn. — Mayo Clinic Cancer Center announced today that it is participating in an expanded access program for the experimental cancer drug MK-3475 at its three sites in Arizona, Florida and Minnesota. MK-3475 is a therapy for the treatment of metastatic melanoma. This program will provide expanded access to the drug prior to its approval by the Food and Drug Administration (FDA).
MK-3475 received “breakthrough therapy” designation from the FDA based on early interim results from a single-arm, open-label Phase I study in 85 patients with surgically unresectable metastatic melanoma. In that trial, the drug had a 51 percent objective response rate. The objective response includes patients with a complete response, those whose tumors were no longer detectable, and those whose tumors shrunk by at least 30 percent compared to baseline.
An update of this trial was published in the New England Journal of Medicine in July 2012 and reported data on 135 patients with advanced melanoma who had or had not received prior therapy with the immunotherapy drug ipilimumab and who were treated at different doses and dose frequencies. The confirmed objective response rate was 38 percent (44 of 117 patients) for the entire cohort and responses did not differ significantly between patients who had received prior ipilimumab treatment and those who had not. Overall, 77 percent of patients had a reduction in tumor burden (a reduction in the number of cancer cells, the size of a tumor, or the amount of cancer in the body) and the responses were durable in the majority of patients.
In updated data presented at the Society for Melanoma Research meeting in November 2013, the reported disease control rate was 61 percent and the objective response rate was 41 percent, with 9 percent of patients achieving a complete response independent of previous ipilimumab therapy.
Mayo Clinic Cancer Center participated in the phase I and phase II studies of MK-3475. Roxana Dronca, M.D., serves as the overall principal investigator of the trial at Mayo Clinic in Rochester. Richard Joseph, M.D., at Mayo Clinic in Florida and Alan Bryce, M.D., at Mayo Clinic in Arizona serve as co-principal investigators.
The expanded access program for MK-3475 is available at Mayo Clinic Cancer Center sites in Arizona, Florida and Minnesota. For more information, call 507-538-7623.
About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 507-538-7623.
About Mayo Clinic
Recognizing 150 years of serving humanity in 2014, Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit 150 years.mayoclinic.org, http://www.mayoclinic.org/ and newsnetwork.mayoclinic.org.
Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, firstname.lastname@example.org