Researchers Discover Breakthrough Treatment For Advanced Squamous Cell Carcinoma

June 7, 2018 | by Maxine Nunes

Badri Modi CV Bio image Badri Modi, M.D.
A couple of years ago, Timothy Satterfield, a retired chef, noticed a tiny mole on his forehead. It was diagnosed as squamous cell carcinoma and removed with Mohs surgery. The margins were clear and all was good.
Two years later he felt a bump under his ear. The cancer was back and had attacked his parotic gland, so he underwent radiation and chemotherapy. The doctors thought they’d gotten it all, but ordered a CAT scan just to be sure. What it showed was that the cancer had metastasized to his lungs.
“The radiation and chemotherapy hadn’t worked — and then I found out there was no other treatment for it,” said Satterfield. “I was scared, as you can imagine.”
The harsh truth he had to face was that there was no standard of care for advanced squamous cell carcinoma. The outlook seemed hopeless.
Then he was referred to City of Hope, where a breakthrough immunotherapy trial is proving to be a game changer. The study has just been published in the New England Journal of Medicine.
“This is a precedent-setting, pivotal trial that could finally establish a standard of care for advanced squamous cell carcinoma of the skin,” said one of the study’s investigators at City of Hope, dermatologist Badri Modi, M.D. “It’s part of the immunotherapy revolution.”
But it’s taken awhile for this disease to get the same attention many other cancers have had.

The First Trial of Its Kind

Cutaneous squamous cell carcinoma is the most common form of skin cancer after basal cell carcinoma, with one study estimating up to 700,000 new cases diagnosed each year, accounting for nearly 9,000 deaths.
This is the first reported immunotherapy trial for the disease in its advanced form. Subjects were enrolled across several institutions, including City of Hope, and given a drug called cemiplimab, which was developed by Regeneron.
Participants in the trial are all patients whose squamous cell carcinoma was so advanced that they were not candidates for surgery or radiation, or had not responded to those treatments previously.
Prior to this study, if surgery or radiation were not good options for such patients, they were treated with chemotherapy or targeted therapies meant for other types of cancer. The response rates were between 10 and 30 percent, often did not last long and caused significant toxicities. Now, six months into this trial, the outcomes are unprecedented.
“Our results show that about one half of patients with advanced cutaneous squamous cell carcinoma who were treated with cemiplimab experienced a response, and most patients tolerated therapy,” Modi said.

How Cemiplimab, the Trial Drug, Works

A healthy immune system will identify and attack “foreign” cells, but many factors can interfere with this process. In fact, cancer itself can outsmart it.
“Think of your immune system as roaming the body policing and looking for different abnormal signals,” Modi explained. “Well, tumors can put up little blocks that disrupt the surveillance. It’s like the Harry Potter Cloak of Invisibility.”
Cemiplimab belongs to a class of immunotherapy drugs known as PD1 immune checkpoint inhibitors. “Essentially, they remove that cloak, allowing the immune system to wreak havoc on the tumors.”
One of the patients treated successfully was Satterfield. “Within six months, he’s shown a complete response. All those spots in his lungs had melted away,” said Modi.
Satterfield also experienced minimal side effects.
“What’s amazing is that other than a little bit of fatigue — and I mean a very slight fatigue — I had no side effects I can tell you about. I’m not sick to my stomach like I was on chemotherapy and I gained back the 40 pounds I lost,” Satterfield said.
And what does a chef trained in sophisticated French and international cuisine crave when he gets his appetite back?
“Hamburger,” he said. “I wanted a hamburger.”
Satterfield often thinks about all the people with his condition who weren’t fortunate enough to be in this study. “I understand that I'm the luckiest person on earth right now,” he said.
The trial will continue, as they follow patients over a longer period of time. And Modi looks forward to further trials being launched. While surgery remains the standard of care for treatment of squamous cell carcinoma when it is possible, he wonders whether there is a role for immunotherapy to be combined with surgery to reduce the rate of disease relapse and metastasis.
“It’s exciting to be part of this,” said Modi. “It’s been very rewarding and I look forward to continuing to work on it, figuring out how immunotherapy is going to help these patients.”

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