FDA Fast Tracks Skin Cancer Drug After Success That Began at the START Center

By Kyriakos Papadopoulos, MD
Tuesday, October 30, 2018

Immunotherapy is the new frontier in cancer treatment, and researchers at START are at the forefront. START is one of the largest Phase 1 clinical trial organizations in the world.

Kyriakos Papadopoulos, MD

Pembrolizumab (Keytruda), an immunotherapy first tested at START in San Antonio’s Medical Center, is now approved for the treatment of several solid tumors. Building on that success, START researchers have now played a pivotal role in the development of cemiplimab, a monoclonal antibody targeting the checkpoint inhibitor PD-1. Initially tested in San Antonio, cemiplimab has been shown to be effective in the treatment of advanced cutaneous squamous cell carcinoma (CSCC) and is now under priority review for approval by the FDA. Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for approximately 7,000 deaths in the U.S. each year. There is currently no FDA-approved treatment for CSCC.

Among patients treated in the Phase 1 clinical trial with cemiplimab is David Crouch, MD, a surgical oncologist who began his career at downtown San Antonio’s Brady Green Hospital and later operated on wounded soldiers at a MASH-like hospital in Vietnam. But the surgical oncologist never fully understood what it felt like to get a second chance at life, until recently. A couple of years ago, he felt a rough spot on his temple that was eventually diagnosed as squamous cell carcinoma. Despite numerous surgeries, radiation and chemotherapy, the cancer spread. He had exhausted conventional oncology treatments and was making funeral arrangements when he was referred to the Phase 1 team at START, where he qualified for the drug trial of cemiplimab. After a year on treatment, scans now show no evidence of the disease.

“It’s like winning the lotto,” says Dr. Crouch. As a physician, Dr. Crouch realizes he’s not home free, but he is extremely thankful he experienced firsthand the benefits of trial participation at START.

“It is extremely gratifying to be able to provide our patients early access to novel therapies that can positively impact not only their survival, but also their quality of life,” says Kyriakos Papadopoulos, MD, Co-Director of Clinical Research at START.

In addition to the treatment of squamous cell carcinoma, cemiplimab has also shown promising results in other types of cancers including lung and cervical cancer.

For more information, please visit thestartcenter.com or call 210-593-5790.