From OHC, Specialists in the Treatment of Adult Cancers and Blood Disorders
August 24, 2021
OHC is part of the nation’s largest research network specializing in oncology clinical trials, US Oncology Research, which has played a role in more than 100 FDA approved cancer therapies. OHC’s pioneers in research continue to lead in cancer clinical trials. On July 16, the FDA approved Rezurock (belumosudil) for the treatment of chronic graft-versus-host-disease (GVHD) in patients aged 12 and older who have failed multiple treatment options. OHC was one of seven sites in the US and the only site in the Tri-State to enroll patients in the phase 2 study for this drug. Because phase 2 was successful, the trial progressed to phase 3 and phase 3 results were submitted to the FDA for approval.
Chronic GVHD is a debilitating immune condition that can occur after an allogeneic transplant (one that uses donor bone marrow or stem cells). The donated bone marrow or stem cells (graft) view the patient’s cells (host) as foreign and attack the patient’s body. This can result in inflammation and scarring of tissues like the skin, eyes, joints, liver, and lungs, and impaired quality of life.
Rezurock is a kinase inhibitor designed to reduce the body’s inflammatory response by blocking a specific protein called Rho-associated coiled-coil kinase 2, or ROCK2. Rezurock is the first and only approved therapy targeting ROCK2.
OHC enrolled three of the 54 patients in the phase 2 portion of the trial which took place between September 2016 and March 2018. All patients had undergone an allogeneic stem cell transplant for treatment of non-Hodgkin lymphoma. According to results published in the Journal of Oncology last April, Rezurock demonstrated an overall response rate of 65% and improved patient quality of life.
Data from the phase 3 study, ROCKstar, showed an overall response rate of 75%. “ROCKstar data indicates that Rezurock is a well-tolerated promising therapy for what can be a very incapacitating condition,” said OHC’s James H. Essell, MD, medical oncologist, hematologist, blood and marrow transplant specialist, and principal investigator for OHC’s phase 2 study. “The majority of the patients in the phase 3 study did not require new systemic treatment for at least one year.”
OHC’s search for new treatments is relentless. Our nationally recognized clinical trials team, led by the principal investigators listed below, is engaged in a passionate search for better ways to prevent, screen for, diagnose, and treat cancer. Giving our patients immediate access to innovative treatments through clinical trials offers them a newfound sense of hope with positive outcomes.
OHC’s Clinical Trial Principal Investigators
E. Randolph Broun, MD – Leukemia
Cynthia C. Chua, MD – Gynecologic Cancers
James H. Essell, MD – Cellular Therapies
Edward A. Faber, Jr., DO, MS – Myeloma
Peter R. Fried, MD – Radiation
Miguel Islas-Ohlmayer, MD – Lymphoma
Mark E. Johns, MD – Gastrointestinal Cancers
Suzanne M. Partridge, MD – Breast Cancer and Melanoma
Joseph N. Shaughnessy, MD – Radiation
Patrick J. Ward, MD, PhD – Breast and Lung cancers
David M. Waterhouse, MD, MPH – Genitourinary and Lung cancers