Advanced melanoma patients, and the doctors who care for them, got the best possible news last week.
Early results from a new study confirmed what many already knew. The drug pembrolizumab, also known by its brand name, Keytruda, helped some patients with the deadliest form of skin cancer survive at least three years rather than just a few months.
"We have been expecting these longer-term results and waiting for the studies to be completed. Now we know. We can prolong survival in more than a third of patients with advanced disease — a disease that was, just a few years ago, almost always fatal," said Dr. Nikhil Khushalani, a medical oncologist and associate member in the Department of Cutaneous Oncology at Moffitt Cancer Center.
He called the drug and others like it a game changer for the management of advanced melanoma and possibly other cancers in the future. Early next month, the full results will be formally presented at the annual meeting of the American Society of Clinical Oncology in Chicago.
But Carl Paulk already knows about Keytruda. In 2012, he had advanced melanoma and a grim prognosis. Standard treatment couldn't stop the cancer, and experimental drugs he tried were too toxic. It wasn't long before doctors were able to offer Paulk, then 65, something new: a drug that blocks a protein that prevents the immune system from attacking cancer.
Paulk, a Tarpon Springs roofer first profiled in the Tampa Bay Times in 2014, signed up for the clinical trial and made the long drive to Moffitt every three weeks to receive an infusion.
The effect in Paulk and about 25 to 35 percent of patients was remarkable. They lived longer than others. The drug was so promising that in 2014 the clinical trial was stopped early and Keytruda was given special FDA approval so it could be offered to advanced melanoma patients who didn't respond to standard treatment.
Today, Paulk still marvels at the drug he is certain is keeping him alive. "I'm so happy that I was part of the test study that proved this to be a great drug, with almost no side effects," he said.
Now doctors have to answer a difficult but critical question: How long should patients be treated with Keytruda? At $8,000 to $10,000 per dose, not including infusion center fees, it's expensive.
"We have to conduct the clinical trials to find this out," said Khushalani. "Maybe we stop the drug, wait and watch and restart it if the cancer returns. We just don't know yet. It's difficult to take patients off a drug if they are benefiting."
For now, Paulk still receives an infusion every three weeks. And he still doesn't mind the long drive from Tarpon Springs to Moffitt one bit.
To read the original story about Carl Paulk, visit tbtim.es/9kw. Contact Irene Maher at [email protected]