The Cutaneous Oncology Program at the George Washington University (GW) Cancer Center was selected as the first global site for a clinical trial for patients with high-risk cutaneous cell carcinoma. GW Cancer Center was selected for this Regeneron-sponsored Phase II clinical trial in neoadjuvant immunotherapy for high risk cutaneous squamous cell carcinoma due to its growing regional and global reputation for treating patients with advanced squamous cell carcinoma, the second most common form of skin cancer behind basal cell carcinoma.
Sponsored by American Biotech company, Regeneron will examine outcomes for patients treated with Libtayo® (cemiplimab)—an immunotherapy treatment—prior to surgery and radiation therapy. The phase II trial is intended to investigate the safety and effectiveness of Libtayo in helping reduce the size of tumors and prevent recurrence in high risk cutaneous squamous cell carcinoma, particularly when given early. The study, currently only available at the GW Cancer Center, is estimated to enroll over 75 participants.
In June 2019, the GW Cancer Center was selected as the first global site for a related clinical trial on the effectiveness of Libtayo given after primary surgery and radiation therapy. This new study will focus on the impact on Libtayo on tumors prior to surgery, with a goal to help shrink the tumor and potentially prevent the cancer from returning or metastasizing. The preliminary results from a similar trial at MD Anderson Cancer Center revealed promising responses to pre-surgical checkpoint inhibitors in patients with advanced cutaneous squamous cell carcinoma of the head and neck.
GW has A Growing Tier I Reputation
Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the GW Cancer Center and principal investigator of the study, emphasized: “By being selected as the first global site for not one, but two clinical trials in 2019, we are continuing to grow our reputation as one of the most innovative programs for patients with advanced cutaneous squamous cell carcinoma.” He continued, “Our growth means more patients in our region will have access to the latest potentially promising treatments and therapies.
Transformational Research and Personalized Therapy
Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences, reported: “This clinical trial fits clearly within our mission to drive transformational research and personalized therapy.” He emphasized, “Our role as an academic cancer center means we are uniquely positioned to get the latest therapies from bench to bedside, and expanding our clinical trial offerings highlights our commitment to advancing both cancer research and patient care.”
What is Libtayo?
Libtayo was approved by the US Food and Drug Administration in September 2018 as cemiplimab-rwlc to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available in advanced cutaneous squamous cell carcinoma in the U.S. Current treatment options for the disease include surgery (such as Mohs micrographic surgery), radiation therapy, and systemic chemotherapy for metastatic disease. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The potential use of Libtayo in neoadjuvant cutaneous squamous cell carcinoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.
“Clinical investigations like this one are critical to expanding the treatment options available to patients,” said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. “By examining neoadjuvant applications of immunotherapy drugs like Libtayo, the hope is that patients will be able to be treated with less invasive surgeries or avoid surgery altogether.”
Mitchell Smith, MD, PhD, associate center director for clinical investigations
Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences
Call to Action: Do you or a loved one have a cutaneous cell carcinoma diagnosis? And do you live in the DC metro area? You may want to consider GW Cancer Center. See Dr. Smith’s contact information.