Neovii Announces Publication in Journal of Clinical Oncology Demonstrating Grafalon® Reduces Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Cell Transplantation

RAPPERSWIL, Switzerland, Oct. 24, 2017 /CNW/ - Neovii Pharmaceuticals AG ("Neovii") today announced the publication in the Journal of Clinical Oncology¹ of the results of a prospective, randomized, double blind, phase 3, trial investigating the utility of Grafalon® (anti-T lymphocyte globulin or ATLG) in reducing moderate to severe chronic graft-versus-host-disease (cGVHD) in patients undergoing matched unrelated donor hematopoietic stem cell transplantation (HSCT) with one of three myeloablative conditioning regimens. The Journal of Clinical Oncology is the official publication of the American Society for Clinical Oncology. To access the online publication, please click http://jco.ascopubs.org/.

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The study, in contrast to previously published Grafalon® studies, did not achieve the primary endpoint in the overall population but did demonstrate a statistically significant reduction in acute GVHD II-IV as well as moderate and severe cGVHD. A post hoc analysis demonstrated a striking relationship between the underlying conditioning regimen and clinical outcomes. Additionally,

• Moderate to severe cGVHD-free survival was significantly superior for Grafalon® patients who received busulfan and fludarabine-based conditioning (HR 0.56, 95% CI, 0.32, 0.96, p=0.034) while OS and PFS were similar (HR 1.16, p=0.64; HR 1.09, p=0.76, respectively), consistent with the study's goals and the results of previously published phase 3 studies.
• Among total body irradiation (TBI) recipients, Grafalon® was associated with inferior PFS (HR 2.65, 95% CI, 1.29, 5.45, p=0.008) and OS (HR 3.47, 95% CI, 1.43, 8.36, p=0.006).
• This study uncovered an important relationship between the recipient's absolute lymphocyte count prior to Grafalon® infusion and outcomes which advances our understanding on how we might optimize the therapeutic window.

"This large and well controlled study builds on the knowledge we have in treating patients undergoing hematopoietic cell transplant," commented Robert J. Soiffer, MD, Chief, Division of Hematologic Malignancies, Co-Chief, Stem Cell Transplantation at Dana-Farber Cancer Institute, Professor of Medicine, Harvard Medical School. "This phase 3 trial represents a major advance in the research of cGVHD, a serious and life-threatening condition with significant unmet medical need."

"First and foremost, we thank the patients and clinical research teams who made this study possible. While Grafalon® is approved and used for GVHD prophylaxis in many countries, U.S patients currently don't have an FDA approved treatment option to prevent cGVHD," commented J. Frank Glavin, Vice President and Head of Neovii North America. "The study's results bring us closer to realizing our patient-driven mission to meaningfully advance the care of patients who undergo HSCT."

About the Phase 3 Study

The study was a prospective, randomized, double blind, placebo-controlled multicenter phase 3 study in North America and Australia (NCT01295710). The study enrolled 260 patients 18-65 years of age with acute leukemia or myelodysplastic syndrome undergoing myeloablative HLA-matched unrelated hematopoietic stem cell transplantation. Patients were randomized in a 1:1 double blinded fashion between ATLG given at 20 mg/kg/day IV versus placebo (250 ml of normal saline) given on days -3, -2, and -1 prior to HCT. All patients received antihistamine and IV methylprednisolone at 2 mg/kg on day -3 and 1 mg/kg on days -2 and -1. Conditioning regimens were declared prior to randomization. The primary endpoint was assessed by clinicians utilizing the 2005 NIH consensus criteria and adjudicated by an Independent Endpoint Committee.

Reference

1. Soiffer RJ, et al., 2017: "A Prospective, Randomized, Double-Blind, Phase 3 Clinical Trial of Anti-T Lymphocyte Globulin (ATLG) to Assess Impact on Chronic Graft-Versus-Host Disease (cGVHD) Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation (HCT)". Journal of Clinical Oncology, October 2017; doi: 10.1200/JCO.2017.75.8177.

About GVHD

Graft versus host disease (GVHD) is a serious, life threatening complication that can occur in patients after they receive allogeneic stem cell transplantation. It develops when the new immune system, which arises from the transplanted stem cells (graft), attacks tissues and organs of the recipient (host). Symptoms of GVHD can occur in the skin, eyes, mouth, gut, liver, and lungs. The condition is estimated to occur in 30% to 70% of all patients who receive HSCT.

About Grafalon®

Grafalon® is a rabbit anti-human T-lymphocyte immunoglobulin (ATLG), used as part of immunosuppressive regimens for the prevention of graft versus host disease in stem cell transplantation, prevention and treatment of rejection in solid organ transplantation or as immunosuppressive in the treatment of aplastic anemia (in accordance with country-specific approved indications). With more than 200,000 treated patients to date in more than 50 countries, Grafalon® enjoys worldwide recognition among solid organ and stem cell transplant teams and has transformed the way transplant teams manage the care of their patients around the world.

About Neovii

Neovii is an independent, dynamic and rapidly-growing global biopharmaceutical company with a patient-focused mission to develop and market novel life-transforming therapies. Neovii has been dedicated for over three decades to improving outcomes in transplantation medicine, hemato-oncological and immune disorders. Neovii Pharmaceuticals AG global headquarters is in Rapperswil, Switzerland, with offices in Massachusetts, USA. Its biologics manufacturing facility is in Gräfelfing, Germany. Neovii has a global reach with products sold in over 50 countries worldwide.

For further information, please visit http://www.neovii.com

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