COLUMBUS, Ohio – COLUMBUS, Ohio – A promising new targeted cancer therapy is now available to certain patients with advanced pancreatic cancer – from the comfort of their home. The treatment is available through a first-of-its-kind, entirely telehealth-based targeted cancer drug therapy clinical trial led by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).
Up to 40 adults with advanced or metastatic pancreatic cancer will be enrolled in this phase II study. The study will test how well the smart drug, pemigatinib (pronounced pem-i-gat-in-ib, marketed at Pemazyre) works for the treatment of adult patients with advanced or metastatic pancreatic cancer with specific mutations in the fibroblast growth factor receptor (FGFR) gene. The drug is currently Food and Drug Administration approved for the treatment of bile duct cancers and is being evaluated for FGFR-mutated pancreatic cancer in this clinical trial.
“Traveling for specialized cancer treatment is often cost-prohibitive for patients experiencing cancer – particularly for rare but aggressive types like pancreatic cancer. Telemedicine enabled clinical trials can offer novel cutting-edge targeted treatments,” said Sameek Roychowdhury, MD, PhD, a medical oncologist with the OSUCCC – James and principal investigator of the new study.
Roychowdhury explains that so-called “smart drugs” open a new world of personalized treatment options for patients with cancer. These targeted therapies are “smart” because they target only the genetic mutations contributing to cancer cell growth, delivering genomic-guided, precise treatment for each person’s disease characteristics. In this case, the genetic mutation is in the fibroblast growth factor receptors, or FGFR, which are present in roughly 1.5% of pancreatic cancer patients.
Pancreatic cancer is a rare but often aggressive form of cancer that is diagnosed in about 64,000 people each year. The disease is slightly more common in men and often diagnosed in later, less treatable stages because its symptoms usually occur after it has spread to other parts of the body. While surgery can be curative in the earliest stages of the disease, it is rarely detected before it has spread, and approved treatment options are limited. This, said Roychowdhury, is why expanding access to targeted drug therapy through nationwide telemedicine-enabled clinical trials is so critical.
“There may be hundreds of gene mutations in someone’s cancer. Discovering which ones are driving how the cancer behaves and treating the mutation with novel therapies is the basis of ‘smart drug’ – or precision cancer medicine – research,” said Roychowdhury, who is also a physician scientist with the OSUCCC – James Translational Therapeutics Program. “One of the major barriers for precision oncology clinical trials is the rarity of some gene mutations or disease — which limits pharmaceutical company interest and feasibility.”
The rise of telemedicine represents a silver lining from the COVID19 that Roychowdhury says will help overcome barriers to access for therapeutic clinical trials in oncology.
This new telehealth study will give patients from across the United States access to oral targeted drug therapies without having to travel to a different city. Study participants will have research management with Roychowdhury via telehealth, delivered in partnership with the patient’s local oncologist for standard-of-care follow up. The study has been developed in partnership with Roychowdhury’s mentee, Zachary Risch, MD, who serves as an assistant professor in the College of Medicine.
“Our team’s goal is to develop a network of telemedicine clinical trials that we can offer with nationwide reach. This is a game changer for cancer clinical trials, and more importantly, patients,” said Roychowdhury, who has more than 10 years of experience with FGFR smart drugs. “We are bringing the trial to the patient, instead of the patient coming to the trial.”
The preliminary research on FGFR that helped launch this treatment concept was supported by Gateway for Cancer Research, a nonprofit organization dedicated to exclusively funding early phase clinical trials for all types of cancer. The new clinical trial include partnerships with Incyte Pharmaceuticals, the Pancreatic Cancer Action Network, Foundation Medicine Inc., Tempus, and Caris Life Sciences. The team is also collaborating with community oncology practices including American Oncology Network, US Oncology, Veterans Affairs Administration, and more to come.
“By taking clinical trial treatment options directly to the patient and partnering with community oncologists across the United States, we greatly expand access to patients who need these therapies,” Roychowdhury said. “Being rare, is no longer a barrier for drug development.”
In addition to the clinical trial, Dr. Roychowdhury’s team has created a registry for patients to join and support research on rare types of pancreas cancer.
To learn more about participating in this study or the registry, call 1-800-293-5066. To learn more about gastrointestinal treatment and research at the OSUCCC – James, visit cancer.osu.edu.
