On December 9, 2017 Kadmon Holdings, Inc. (NYSE: KDMN) reported additional positive findings from an ongoing Phase 2 clinical trial demonstrating that KD025, its Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, was well tolerated and resulted in clinically meaningful responses in patients with chronic graft-versus-host disease (cGVHD) (Press release, , DEC 10, 2017, View Source [SID1234522516]). The results are being presented today in a poster at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta (Poster #3256).
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New data from Cohort 2 of the trial (KD025 200 mg BID; n=16) showed an Overall Response Rate (ORR) of 63%, as of a data cutoff date of November 20, 2017. Updated data from Cohort 1 (KD025 200 mg QD; n=17) showed an ORR of 65%. While data from Cohort 2 continue to mature, responses were durable in Cohort 1, lasting five months or longer in 70% of patients. Responses were also rapid: 71% of patients across Cohorts 1 and 2 achieved response by the first assessment (after 8 weeks of treatment). Responses were observed across all affected organs, including Complete Responses (CRs) in upper and lower gastrointestinal (GI) tract, mouth, skin, joints, esophagus, eyes and liver. In addition, 64% of patients from Cohorts 1 and 2 were able to reduce steroid dose, and four patients completely discontinued steroids. Eighty-three percent (83%) of patients were able to reduce dose of tacrolimus, another immunosuppressive agent used to treat cGVHD. KD025 was well tolerated, with no drug-related serious adverse events (SAEs) in either cohort.
"Treatment with KD025 has demonstrated clinical activity across multiple organs affected by cGVHD, including CRs in difficult-to-treat fibrotic manifestations such as those in eyes and joints," said Madan Jagasia, MD, MS, MMHC, Professor of Medicine; Chief, Section of Hematology-SCT, Medical Director, Division of Hematology-Oncology, Vanderbilt University Medical Center; Co-Leader, Translational Research and Interventional Oncology; Vanderbilt-Ingram Cancer Center; and study investigator. "In addition, KD025 has been well tolerated, with no drug-related SAEs, and does not appear to increase risk of infection, a common consequence of immunosuppressants frequently used to treat cGVHD."
"The overall response and durability of response observed are particularly compelling in this complex patient population, the majority of which had cGVHD involvement in four or more organs," said Harlan W. Waksal, M.D., President and CEO at Kadmon. "We will continue to observe response rate, durability and safety in this ongoing clinical trial as well as in future planned studies of KD025 in cGVHD."
The ASH (Free ASH Whitepaper) poster is now available on the Investors section of Kadmon.com, under "Presentations & Events." Additional data and analysis from the KD025-208 study will be provided on Monday, December 11, 2017, after market close (4:00 p.m. ET), via slides that will be available on the Investors section of Kadmon.com.
About KD025-208
KD025-208 is an ongoing Phase 2 clinical trial of KD025 for the treatment of cGVHD. The trial is being conducted in adults with steroid-dependent or steroid-refractory cGVHD and active disease. The dose-finding trial includes 48 patients divided into three cohorts at different dose levels (KD025 200 mg QD, 200 mg BID and 400 mg QD), enrolled sequentially following a safety assessment of each cohort. An expansion cohort of approximately 40 patients will be enrolled after the optimal dose has been determined. In October 2017, KD025 received orphan drug designation from the U.S. Food and Drug Administration for cGVHD.
About cGVHD
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation, a procedure that is often used to treat patients with cancers such as myeloma or leukemia. With cGVHD, transplanted immune cells (graft) attack the patient’s cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and GI tract.