PHILADELPHIA – Researchers from the Abramson Cancer Center of the University of Pennsylvania announced today that findings from two large, international clinical trials show unprecedented survival for patients with multiple myeloma, a cancer that occurs in the blood-making cells of bone marrow. The findings show that when the oral drug lenalidomide (REVLIMID®), is taken in combination with the steroid dexamethasone, patients significantly improve by all measures– including a median survival of nearly three years – the longest median survival known for this difficult to treat patient group.
Edward A. Stadtmauer, MD, Director of the Abramson Cancer Center Bone Marrow and Stem Cell Transplant Program and lead investigator from Penn, was part of the U.S. study published today in the New England Journal of Medicine alongside a companion study from Europe showing similar results.
"This study shows that this new class of drugs is a critical advance toward helping address the increase in the number of diagnoses for myeloma,” said Stadtmauer. "While most U.S. cancer diagnoses are decreasing, statistics show that the number of myeloma diagnoses is increasing, particularly in younger patients,” said Stadtmauer.
REVLIMID® (lenalidomide) from Celgene, an oral medication which treats without the ravages of chemotherapy, is the first in a new class of medications called immunomodulatory drugs (IMiDs). It works by attacking both the cancer cell and the micro-environment in which it lives in the bone marrow, thereby stopping the cells’ ability to adhere to the wall of tissues where they will grow. REVLIMID® also inhibits cancer cells’ ability to hide from the body’s natural killer cells in the immune system by stopping angiogenesis – the growth of blood vessels that penetrate into and feed cancerous tumors causing them to proliferate.
In both the US and European studies, patients for whom all previous treatments had failed were given either lenalidomide plus dexamethasone – a potent synthetic steroid – or dexamethasone with placebo. These trials were designed to investigate the effectiveness and safety of cyclic dosing of
REVLIMID® at 25mg combined with high-doses dexamethasone (HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. A total of 705 patients were enrolled in 97 sites internationally. Patients in both trials had been heavily treated prior to enrollment, many having failed three or more rounds of chemo and/or radiation therapy. In addition, more than 50 percent of patients enrolled had undergone stem cell transplantation. In these new studies REVLIMID® plus dexamethasone achieved superior results compared to dexamethasone alone regardless of the history of treatment, including the media survival of nearly three years. Such positive patient response suggests that treatment with REVLIMID® early in the course of the disease may be beneficial. These findings have caused a change in the official physician guidelines for multiple myeloma which were recently updated to add REVLIMID® as an initial treatment, instead of waiting until other treatments have failed.
In Europe and the US, REVLIMID® is being used to threat myeloma. In the US it is also approved for a pre-leukemia condition called myelodysplastic syndrome (MDS). It is also being tested in other leukemias, lymphomas, and solid tumors.
“The last five to ten years have been the most wonderful time to be a physician treating multiple myeloma, thanks to advances like lenalidomide,” said Stadtmauer. “Twenty, thirty years ago, there wasn’t much we could do for these patients. We couldn’t really treat the disease effectively so we tried to treat the symptoms with only two or three types of chemotherapy and radiation, which of course have their own negative side-effects. Now, we have this new, highly effective class of drugs with very low side effects. Before, we hoped for a positive response in patients. Now, we expect one.” Adds Stadtmauer, “Thanks to new agents like lenalidomide, we’ve been able to convert this disease from a killer to more of a chronic illness.”
The data from these studies were published in two separate articles in the NEJM, by lead authors Donna Weber, MD, Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center, and Meletios Dimopoulos, MD, Associate Professor, Department of Clinical Therapeutics at “Alexandra” Hospital, Athens, Greece.
PENN Medicine is a $3.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.
Penn's School of Medicine is currently ranked #3 in the nation in U.S.News & World Report's survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.
The University of Pennsylvania Health System includes three hospitals — its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation’s “Honor Roll” hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center — a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.
Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $5.3 billion enterprise.
The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 18 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $373 million awarded in the 2015 fiscal year.
The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center -- which are recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report -- Chester County Hospital; Lancaster General Health; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Chestnut Hill Hospital and Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2015, Penn Medicine provided $253.3 million to benefit our community.