FDA approves advanced skin cancer drug tested in SA
Monday, October 1, 2018
Patients with certain advanced skin cancers have new hope after the FDA approved a new drug that was investigated in clinical trials in San Antonio.
The drug will be marketed as Libtayo for the treatment of advanced cutaneous squamous cell carcinoma.
The immunotherapy known as cemiplimab in clinical trials was tested on patients at the South Texas Accelerated Research Therapeutics Center, or START.
“This drug showed remarkable results in patients who had exhausted conventional cancer treatment,” said Dr. Kyriakos Papadopoulos, chief investigator of the initial trial at START.
Dale Biggs, 63, was among the test patients.
“The tumors were so big, I couldn’t get (my) hat on,” he said.
Biggs head was covered in walnut-sized tumors. Years of working in the sun eventually led to an aggressive skin cancer.
“It just exploded across the top of my head,” he said.
When surgery and chemotherapy failed to stop the cancer, Biggs signed on for the experimental treatment. After a few weeks, he said he returned to visit his doctor.
“I said, ‘Are you ready?’ And I took the hat off. He just leaned back and started laughing,” Biggs said. “He picked up the phone and called the director of the drug trial and said, ‘Come see a miracle.’”
The before and after pictures reveal the miraculous change. Biggs received the intravenous drug every two weeks, and after six weeks, the tumors were gone.
Dr. David Crouch, 83, was another clinical trial patient who calls the drug a lifesaver.
“For me, it was very dramatic,” he said.
He also was facing a dismal prognosis for advanced squamous cell carcinoma, but after treatment is now cancer-free.
After such remarkable results, the FDA fast-tracked approval for patient use. The drug was developed by Regeneron and Sanofi.
“Essentially, the drug allows the body’s immune system to recognize tumors and subsequently kill them,” Papadopoulos said. “For a disease for which there had not been any effective treatment, it was gratifying to see how quickly the majority of patients began to respond to treatment and also how durable those responses have been."
At START, 53 patients with various types of cancer were treated with the investigational drug. While the FDA approval is only for certain skin cancers in U.S. patients, Papadopoulos said, trials are ongoing for treating small cell lung cancer, cervical cancer and liver cancer.