Trial Will Evaluate Use of Pembrolizumab, Known as Keytruda®*, With Cesium-131 and Surgical Resection
RICHLAND, Wash., June 17, 2020 (GLOBE NEWSWIRE) — Isoray, Inc. (NYSE American: ISR) today announced that it has entered into a research grant agreement with the University of Cincinnati Physicians Company for a study involving the treatment of recurrent head and neck cancers. University of Cincinnati Physicians Company is the multispecialty practice group for University of Cincinnati (UC) College of Medicine and UC Health.
The planned trial will evaluate the safety and early effectiveness of the addition of pembrolizumab (Keytruda) to the regimen of Cesium-131 with surgical resection. Pembrolizumab (Keytruda) is a humanized antibody used in cancer immunotherapy. A total of 50 patients whose head and neck cancers have recurred and who are eligible for surgical resection are planned to be enrolled.
The study, A Trial Combining Pembrolizumab and Cesium-131 Brachytherapy with Salvage Surgery in Head & Neck Squamous Cell Carcinoma, will be carried out under the direction of principal investigators Dr. Shuchi Gulati and Dr. Chad Zender at the University of Cincinnati Medical Center. There is potential for other centers to participate in the study.
Isoray CEO Lori Woods says this is an exciting step forward. “Much speculation exists as to the possible synergy of traditional therapies such as radiation therapy with modern immunotherapy or immune checkpoint inhibitors. With the expansion of these types of therapies into the treatment of numerous cancers, I believe that we are rapidly approaching an era of Immuno-Oncology.”
“Exploring these possible synergies as they relate to Cesium-131 is another step forward in our efforts to deliver effective new applications to the treatment of hard to treat cancers like head and neck cancers. We at Isoray are committed to continuing to be a force for leadership in the field of brachytherapy and making a difference for patients and the doctors who treat them,” said Woods.
Cancers of the head and neck that recur following the usual primary treatment involving surgery and radiation are difficult to successfully treat. Recurrence rates of 50% that occur at two years are typical. The use of immunotherapy in this study (immune checkpoint inhibition) in tandem with resection and Cesium-131 brachytherapy presents an attractive therapeutic concept. In this approach, the patient’s immune system may assist in the clearing of disease sites outside the surgical and radiation fields. A previous multi-institutional study has provided evidence that the use of Cesium-131 with surgical resection is well-tolerated in the treatment of recurrent head and neck cancers.
*Keytruda is the trademark registered to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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Isoray, Inc., through its subsidiary, Isoray Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release about Isoray’s future expectations, including whether the study discussed in this news release will be successful and have favorable outcomes, the advantages of Cesium-131 and its delivery systems coupled with immunotherapy, the perception by patients of quality of life outcomes compared to other treatment options, whether demand for and use of Cesium-131 will increase or continue as anticipated and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as the impact of COVID-19 on our financial results, suppliers, employees and scheduling of procedures, whether ongoing patient results are favorable and in line with the conclusions of clinical studies and initial patient results, physician acceptance, training and use of our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, changes in laws and regulations applicable to our products, and other risks detailed from time to time in Isoray’s reports filed with the U.S. Securities Exchange Commission. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.