PITTSBURGH, Pa. (WTAJ)– UPMC Hillman Cancer Center has released findings of a study where immunotherapy called pembrolizumab has reduced cancer reoccurrence in patients with stage IIb and IIc melanoma, according to a press release.
Pembrolizumab is normally used in the surgical removal of stage III melanoma as adjuvant therapy, as well as treatment of metastatic stage IV melanomas. The FDA however, still has not approved the drug for patients with earlier stages, such as IIb and IIc melanomas in which invasive tumors that extend deep into the skin or have broken the overlying skin, which is known as ulceration.
M.D. director of the Cancer Immunotherapeutics Center at UPMC Hillman and associate professor of medicine at the University of Pittsburgh School of Medicine Jason Luke led the study. He announced the results of the study on behalf of a leading international group of melanoma oncologists, and as well as the study sponsor Merck, at a presentation today, Sept. 18, at ESMO Congress 2021.
“Patients with stage IIb and IIc melanomas have a high level of risk for the disease coming back after surgery,” said Luke. “This is a very important clinical trial as it shows that pembrolizumab reduces that risk. Based on these results, I believe that we should be offering patients in this situation the opportunity to get this treatment after surgery.”
The multi-country KEYNOTE-716 trial enrolled 976 patients with stage IIb or IIc melanomas, according to the release. Post-surgery, 487 patients were administered pembrolizumab and 489 received a placebo every three weeks for one year. Patients were monitored for cancer recurrence via computed tomography scans and magnetic resonance imaging.
It was found that those who were given the drug had a 35% less chance of death or melanoma relapse to those who were given the placebo. An application for the drug to be used for stage IIb and IIc of melanoma with pembrolizumab has been submitted by Merk and is currently under review by the FDA.
“The trial is still very early, and we expect to see the benefit of pembrolizumab increase above 35% over time,” said Luke.
For the second part of the trial, those that were given the placebo and had their cancer return will now be offered the pembrolizumab so doctors can decide whether to give the drug right after melanoma surgery or wait until the cancer returns.
For now, the KEYNOTE-716 trial is ongoing, and the researchers will continue to monitor participants for cancer recurrence or death.
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