St. Luke’s Cancer Center offers new Phase II oncolytic viral therapy clinical trial for advanced melanoma

St. Luke’s Cancer Center is a leader in offering clinical trials for patients with melanoma, the most unusual type of skin cancer and also the most deadly. Physicians such as Sanjiv Agarwala, MD, Chief of Medical Oncology and Hematology for St. Luke’s University Health Network and an internationally recognized melanoma specialist, are committed to bringing the most promising studies to the Lehigh Valley.

An oncologist for nearly 20 years, Dr. Agarwala said during his first 15 years of practice there was no effective treatment for melanoma in advanced stages until a major breakthrough about five years ago. “Then, we cracked the code,” he says. “We began to look at the immune system and target cells that attack melanoma cells. Some of the treatments turn on cells that fight cancer and others prevent cells that fight the disease from being turned off. We’re using science to better understand the disease and then using that knowledge to create targeted treatments. It truly is an exciting time to be involved in melanoma research and treatment.”

St. Luke’s Cancer Center has become the first center in the world to offer a new Phase II oncolytic viral therapy for advanced melanoma from the Japanese innovative biotechnology company, Takara Bio, Inc. recently enrolling the first patient. Using biotechnology, viruses are converted into therapeutic agents to destroy cancers. This promising therapy uses the injectable strain of the Herpes simplex virus, HF10, to destroy cancer cells and produce an anti-tumor immune response. Since the study is Phase II, patients still receive the standard-of-care therapy for advanced melanoma, the FDA-approved drug ipilimumab, along with this new viral treatment.

Dr. Agarwala was approached by Takara Bio, Inc. to participate in the study earlier this year, during the annual Melanoma Symposium in New York City, a prestigious clinical conference attended by health care professionals and researchers world-wide. He has chaired this program for the past 11 years.

St. Luke’s Cancer Center was also the first in the region to offer ipilimumab to patients prior to FDA-approval as part of an expanded access clinical research program in 2010 and 2011. Through several clinical trials, many of which St. Luke’s was a major contributor, ipilimumab has been shown to help some people with advanced melanomas live longer by targeting CTLA-4, a protein that suppresses the T-cell immune response, thus leading to its FDA approval in 2011.

Dr. Agarwala has also been involved in research with antibodies that target a receptor called PD-1, which may be twice as effective as ipilimumab in treating patients with late-stage melanoma. St. Luke’s participates in clinical trials with a PD-1 antibody from Bristol Myers called nivolumab, which recently received FDA approval, serving as a major enroller to several clinical trials ultimately resulting in this FDA approval. These treatments are intended for patients with advanced melanoma who have received ipilimumab and have progressed on that treatment. Perhaps this is most promising area of Dr. Agarwala’s research – the discovery of unique mutations in melanoma cells, which is a key risk factor in drug development to target these mutations and kill the melanoma cells.

“People should not be afraid to participate in a clinical study,” says Dr. Agarwala. “Trials are closely monitored and patients receive excellent care. Clinical trials require frequent designated evaluation points beyond what is typical. As a result, patients often feel they get more attention and oversight of their care. In addition, staff members are specifically assigned to work with patients enrolled in trials.” Dr. Agarwala encourages all of his patients to participate in a clinical trial and estimates that he has 30-50 patients enrolled in various studies at any given time.

St. Luke’s University Health Network values this innovation and is able to effectively provide such novel therapies to its patients through the experienced physicians in practice such as Dr. Agarwala, as well as the centralized Clinical Trials Office under the leadership of Tracy Butryn, Director of Clinical Trials and Research. “These examples are a true testament to how clinical trials and research serve as a forefront to advancing healthcare and the development of new treatments for patients,” says Butryn. “We have a dedicated team and a holistic approach to the care of our patients, not only through standard therapies, but also new and innovative treatments offered through clinical trials. It is truly a rewarding experience, and being part of the development of medicine is something the Clinical Trials Office and our physicians should be very proud of.”