Study results spur drug manufacturer to fund trial expansion for rare pancreas cancer
CHICAGO (June 8, 2023) – Gateway for Cancer Research, a nonprofit organization dedicated to funding transformational early phase cancer clinical trials around the world, announced that success of its groundbreaking Phase I telemedicine blood monitoring trial has prompted a drug manufacturer to fund a new study for pancreas cancer patients across the country.
In 2021, Sameek Roychowdhury, MD, PhD, a medical oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and chair of Gateway’s Research and Grants Peer Review Committee, was awarded $333,927 from Gateway for a telemedicine genetic biomarker (blood testing and tumor monitoring) trial. Launched at OSUCCC – James in 2022, the trial was intended to only include liver bile duct cancer patients whose tumor had the FGFR gene mutation. However, the telemedicine blood-based tumor testing and monitoring trial was ultimately expanded to include pancreas cancer patients with the same mutation after Doug Hull, a Florida resident diagnosed with pancreas cancer, turned to Dr. Roychowdhury because he had the FGFR gene mutation.
“FGFR in pancreas cancer is rare at only about 1%,” said Dr. Roychowdhury. “When Mr. Hull came to us, he had exhausted all available treatment options. We knew from our research that he could benefit from a smart drug against FGFR.”
Hull, now 80, was diagnosed with stage 4 FGFR-positive pancreas cancer in February 2021. Not a candidate for surgery or radiation, his treatment journey ended after he had a life-threatening allergic reaction to chemotherapy. His search for clinical trials led him to Dr. Roychowdhury, one of the country’s foremost leaders in FGFR-positive cancers.
Hull was enrolled in Gateway’s telemedicine trial. He underwent blood monitoring from his home state of Florida and received the smart drug pemigatinib through collaboration between Dr. Roychowdhury and his local oncologist. Hull received the drug after Dr. Roychowdhury appealed for compassionate use of pemigatinib based on his prior experience with similar patients in clinical trials at OSUCCC – James.
With successful outcomes using the FGFR smart drug in five pancreas cancer patients, Dr. Roychowdhury contacted the drug manufacturer about initiating a new study.
“Gateway’s support of investigator-sponsored research, which is focused on areas of unmet need where pharmaceutical companies might not want to venture, laid the foundation and provided the framework for this upcoming trial,” said Dr. Roychowdhury. “With Gateway’s support, we were able to show the drug’s potential in treating patients with pancreas cancer. This wouldn’t have happened without the insight we learned through Mr. Hull’s treatment and support from Gateway.”
Incyte, the pharmaceutical company behind pemigatinib, has committed to supply the drug and clinical trial funding for a forthcoming telemedicine trial of pemigatinib in pancreas cancer patients with the FGFR mutation. Like the initial Gateway-funded trial, the new study will be led by Dr. Roychowdhury and his team at OSUCCC – James. It will include remote blood testing and tumor monitoring for up to 40 patients from across the country. Enrollment is scheduled to begin in late 2023.
“One of the major barriers for precision oncology clinical trials is the rarity of some gene mutations, which limits pharmaceutical company interest and study feasibility,” explained Dr. Roychowdhury. “A silver lining from the COVID-19 pandemic is the rise of telemedicine, which will help overcome barriers for participation in the new trial.”
According to Dr. Roychowdhury, trial patients will not have to travel, will not incur extra costs, will not receive a placebo and, in all likelihood, will benefit from the drug.
“Thanks to Gateway’s support for decentralized clinical studies, telemedicine is becoming a game changer in research with patients being biggest beneficiaries,” said Dr Roychowdhury.
Gateway increased its catalog of decentralized/telemedicine-enabled trials by 400% since the COVID-19 pandemic, which created travel and hospital access restrictions that prevented many patients from participating in clinical studies. The organization continues to push for telemedicine trials where possible.
“Early phase clinical trials are vital to discovering new, groundbreaking cancer treatments,” said Richard J Stephenson, Gateway’s founder and chairman. “Drug manufacturers often won’t invest in these early studies due to the financial risk, but rewards don’t come without risk. Seeing patients like Doug Hull be given hope and a chance to live is incredible.”
Gateway was established in 1991, with a commitment to funding only early phase patient-centered clinical trials for all types of cancer, including rare cancers that are largely underfunded.
“When we see a void in hopeful treatment options for a cohort of patients like those with FGFR pancreas cancer and we have a researcher like Dr. Roychowdhury with data like his, we’re going to step in,” noted Dr. Stacie J. Stephenson, Gateway vice chair and functional and integrative medicine expert. “These people deserve hope, and that’s what we’re committed to giving to patients around the world.”
To learn more about participating in the upcoming drug trial, email Sameek.Roychowdhury@osumc.edu.
About Gateway for Cancer Research
Gateway for Cancer Research℠ is a nonprofit 501c(3) organization committed to funding innovative cancer research that helps people living with cancer to feel better and live longer as we work to end cancer as we know it. Thanks to generous underwriting, 100% of every dollar Gateway receives directly funds Phase I and Phase II cancer clinical trials at leading research institutions around the world. Since its inception in 1991, Gateway has invested more than $105 million to support 227 cancer clinical trials. These studies have delivered hope and healing to more than 10,000 cancer patients, altered the standard of care at some of the world’s most trusted health care institutions, and contributed to new FDA-approved cancer treatments and therapies. Get involved or donate today by visiting GatewayCR.org, like us on Facebook at facebook.com/GatewayforCancerResearch, and join the conversation on Twitter at @GatewayforCR and Instagram at @GatewayforCR, #BeAGateway
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