HACKENSACK, N.J.--( BUSINESS WIRE )--Andre Goy, M.D., Chairman and Director of John Theurer Cancer Center, Chief of the Lymphoma Program and Chief Science Officer and Director of Research and Innovation for Regional Cancer Care Associates, announced today positive results from a phase II study of patients with indolent non-Hodgkin lymphoma (iNHL) published in the New England Journal of Medicine (NEJM). The trial was conducted by Dr. Goy and a number of researchers and physicians from leading institutions around the world.
The importance of the B-cell receptor pathway in B-cell survival and lymphomagenesis is now well established. A number of small new molecules are trying to take advantage by targeting this signaling cascade including the PI3K kinase particularly PI3Kδ (more abundant in lymphocytes), which inhibitor idelalisib (ex CAL-101) showed very promising results in phase I study.1
The data presented in NEJM today reports on a single arm open label phase II study, with 125 patients with iNHL refractory to the two most common therapies used in iNHL (i.e. monoclonal antibody rituximab and alkylating agent). Patients were given idelalisib 150 mg orally BID until progression or withdrawal from study.1
Results demonstrated that idelalisib has antitumor activity in iNHL with tumor reductions in 90% of patients, including 57% achieving an objective tumor response. Responses were seen rapidly (median time to response 1.9 months) and were found durable (median DOR of 12.5 months).1
“There is no established standard therapy in patients with iNHL who have failed the two most classic therapies (rituximab and chemotherapy),” said Andre Goy , M.D., M.S. “Together the efficacy of this new oral agent with a favorable toxicity profile offers new hope to patients particularly for combination with other agents, and as a foundation for non-chemotherapy options in the near future.”
It is estimated that 76,000 people in the United States were diagnosed with NHL. Indolent non-Hodgkin lymphomas constitute approximately one-third of all cases of NHL, and include follicular lymphoma (FL), small lymphocytic lymphoma/leukemia (SLL), marginal zone lymphoma (MZL), and lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM).2-4
This marks the third study by John Theurer Cancer Center published in the prestigious New England Journal of Medicine over the last six months. Last year, Dr. Goy announced the impressive activity of the first BTK (Bruton’s Tyrosine Kinase) inhibitor called PCI-32765 or ibrutinib5. The drug has been approved by the FDA based on clinical studies conducted at John Theurer Cancer Center in previously treated mantle-cell lymphoma patients. Additionally, Scott D. Rowley, M.D., Blood & Marrow Stem Cell Transplantation Division Chief at John Theurer Cancer Center co-authored positive phase II results for a new oral anti CMV agent CMX001, which significantly reduced the incidence of CMV events in recipients of hematopoietic-cell transplants.6
“Our studies in the New England Journal of Medicine demonstrate John Theurer Cancer Center’s commitment to being on the cutting-edge of oncology research, said Andrew L. Pecora , M.D., F.A.C.P., C.P.E., Chief Innovations Officer, Professor and Vice President of Cancer Services, John Theurer Cancer Center and President of Regional Cancer Care Associates. “I want to thank our dedicated staff and research team for their commitment to providing the best possible care to our patients.”
1 Gopal AK, Kahl BS, de Vos S, et. al. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med DOI: 10.1056/NEJMoa131483.
2 Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet . 2012;380(9844):848-857.
3 Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol . 1993;20(5 Suppl 5):75-88.
4 Swerdlow S. Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, J. Thiele (Editor), Vardiman JW. WHO Classification of Tumours of Haematopoietic and Lympoid Tissues (ed 4th); 2008.
5 Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, et al: Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med 2013, 369(6):507–516.
6 Marty F, Winston D, Rowley S, et.al. CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation. N Engl J Med . 2013;369(13):1227-1236.
About John Theurer Cancer Center at Hackensack University Medical Center
John Theurer Cancer Center at Hackensack University Medical Center is among the nation’s top 50 U.S. News and World Report Best Hospitals for cancer – the only ranked in New Jersey with this designation. It is New Jersey's largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.
Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertise—all under one roof. Physicians at John Theurer Cancer Center are members of Regional Cancer Care Associates, one of the nation’s largest professional hematology/oncology groups. For more information please visit www.jtcancercenter.org .
About Regional Cancer Care Associates
Regional Cancer Care Associates (RCCA), one of the largest oncology physician networks in the US, is transforming oncology care by ensuring patients and their caregivers are an active part of the treatment team in all aspects of the management of their disease in a way that is life-enriching and respectful.
Regional Cancer Care Associates extends across New Jersey with more than 90 cancer care specialists, growing to include more than 100, and is supported by 700 employees at 27 care delivery sites, providing care to more than 20,000 new patients annually and over 230,000 existing patients. RCCA takes responsibility to ensure access to the highest quality, compassionate and cutting-edge cancer care for its patients while controlling the cost of this care. For more information visit: www.regionalcancercare.org .