John Theurer Cancer Center Announces Positive Results from Revlimid MCL-001(EMERGE) Study Leading to FDA Approval of First Oral Therapy for Refractory Mantle-Cell Lymphoma (MCL) Patients

HACKENSACK, N.J., Sept. 26, 2013 /PRNewswire/ -- Andre Goy, M.D., M.S., Chairman and Director of John Theurer Cancer Center and Chief of the Lymphoma Program, has just published two important papers in relapsed/refractory mantle-cell lymphoma (MCL) in the Journal of Clinical Oncology and New England Journal of Medicine. MCL is a difficult subtype of non-Hodgkin lymphoma, where patients often become chemoresistant after responding to initial therapy.

Dr. Goy, an international expert in the field, led the lenalidomide global pivotal trial known as MCL-001 or EMERGE trial. Lenalidomide belongs to a category of immunomodulators that is first-in-class approved for lymphoma. This Phase II study showed that lenalidomide induced rapid and prolonged response in patients who were heavily pretreated regardless of the number of their prior regimens and with a median duration of response of more than 16 months. Many of these patients had also been refractory to their last prior therapy. The EMERGE trial results were published in the leading Journal of Clinical Oncology ("Single-Agent Lenalidomide in Patients With Mantle-Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib: Phase II MCL-001 (EMERGE) Study" JCO September 2013).

"This trial led to the recent approval by the FDA of lenalidomide as the first oral compound available for that disease addressing a definite unmet need for these patients," said Andre Goy, M.D., M.S., Chairman and Director, and Chief of Lymphoma, John Theurer Cancer Center and Chief Science Officer and Director of Research and Innovation of Regional Cancer Care Associates. "Lenalidomide is only the second drug ever approved for the treatment of mantle-cell lymphoma."

The second study was published in the New England Journal of Medicine a few weeks ago in collaboration with MD Anderson Cancer Center and a number of institutions around the world. This study reported the impressive activity of the first BTK (Bruton's Tyrosine Kinase) inhibitor called PCI-32765 or ibrutinib. Ibrutinib belongs to a new category of drugs targeting the BCR (B-cell receptor) pathway, which appears very critical for B-cells and lymphoma cells' survival. Ibrutinib was very well tolerated and showed activity in almost three-fourths of the patients with very durable responses. Ibrutinib is currently under priority review by the FDA as an additional therapeutic treatment option. ("Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma" NEJM August 2013).

"These two new drugs represent great hope for patients with relapsed/refractory mantle-cell lymphoma and offer a terrific opportunity moving forward for treatments in combination or after conventional chemotherapy (as maintenance or consolidation), which will definitely improve the outcome of mantle-cell lymphoma patients," said Andre Goy, M.D., M.S.

Dr. Goy previously showed the first activity of bortezomib (proteasome inhibitor) and headed the trials which led to bortezomib approval as the first new drug ever approved by the FDA for relapsed/refractory mantle cell lymphoma.

"As one of the premier Lymphoma programs in the nation, we are committed to being at the forefront of cutting-edge research and treatment," 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. "MCL-001 and the approval of lenalidomide represent a breakthrough in the treatment of mantle-cell lymphoma."

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.

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SOURCE John Theurer Cancer Center