Clinical trials are one step in the long process researchers must follow in order to get a drug approved for the treatment of mesothelioma. Mavis Nye of Seasalter, England, a nearly five-year survivor of mesothelioma who has been desperately seeking a clinical trial, just got word that she has been accepted into one for a drug that is being hailed as a “miracle” by melanoma patients.
Mavis will be the first mesothelioma patient in the UK to participate in the MK-3475 clinical trial. The Phase I trial is run with no placebo allowing each patient to receive the full benefit of the groundbreaking drug. Mavis told MesotheliomaHelp that this is “brilliant news,” as she believes terminally ill patients should not be subjected to a clinical trial if they will receive a placebo with no hopes of benefitting from the drug.
Last week she received a copy of a letter from the researcher to her doctors at The Royal Marsden saying, “I reviewed this lovely lady with mesothelioma at our Phase 1 clinic today (2nd of May), and she is an excellent Phase 1 trial candidate.” Mavis will be accepted into the trial pending results of her latest biopsy.
“That is just music to my ears,” says Mavis in her May 18 article in her blog, “Living with Mesothelioma.”
MK-3475 Clinical Trials Span the Globe
The trial is being run at The Royal Marsden, a world-leading cancer center in the UK, to test the efficacy of the drug developed by Merck in suppressing the PD-L1 biomarker found in cancer cells. PD-L1, or programmed death-ligand 1, is a protein that has been shown to play a role in suppressing the immune system during cancer and other diseases. However, according to an article in OncLive, MK-3475 is a PD inhibitor that blocks PD-L1, allowing the immune system to effectively fight the cancer.
In simpler terms, as Mavis explains it, “They have found that a tumor has a switch that turns off the immune system, but the drug goes in and switches it back on.”
In the trial cited in the OncLive article, researchers report that after six months of MK-3475 treatment, “the overall response rate for patients who expressed PD-L1 was 46% compared with 17% for those who did not.” The results have been overwhelming, and the drug is now under evaluation in 13 trials for more than 30 types of cancer, including mesothelioma.
When Australian Ron Walker, Grand Prix Chairman, gained his life back from melanoma after treatment with MK-3475 he convinced the Therapeutic Goods Administration, the Australian counterpart to the U.S. Food and Drug Administration, to begin offering the drug to other melanoma sufferers, according to an article on News.com.AU.
Walker who had previously been told it was just a matter of time before he would succumb to the cancer received his treatment in a U.S. clinical trial, and although the drug is not yet approved in Australia, the TGA agreed to grant access “to a handful of extreme cases each month.”
“Without the drug I wouldn’t be here,” Walker said. “It is absolutely so simple.”
The U.S. Food and Drug Administration just announced that MK-3475 is fast-tracked under its Priority Review Designation for “the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab [a type of immunotherapy used to treat melanoma that can’t be removed with surgery or has metastasized].”
Drug Offers Hope to Mavis and Her Husband, Ray
Mesothelioma is highly aggressive and is resistant to many cancer treatments. The prognosis for mesothelioma patients is usually grim: the average survival time varies from 4 – 18 months after diagnosis. Mavis is among just five percent of mesothelioma patients who reach the five-year survival mark. For the more than 14,000 people worldwide diagnosed with the disease each year, clinical trials may offer them a breakthrough treatment not yet available anywhere else.
“Someone has given me hope,” says Mavis, now that she is accepted into the trial.
Ray Nye, who has been by Mavis’ side throughout her ordeal, wrote in his May 3 blog “Meso and Me,” when doctors told them that there was no more they could offer Mavis in the way of treatment it was “a smack in the face wake up call.”
But, he adds, with her acceptance into the trial, “Some weight has been lifted off my shoulders. Some chink of light at the end of the tunnel. Some more time to do things together. Any other scenario holds nothing but unbearable pain for me.”
“Don’t stop. Mavis I love you and I want to go on loving you for a long time to come.”