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.
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