Oral drug sets new survival standard for bone marrow cancer: Abramson Cancer Center participates in landmark Phase III study for myeloma treatment

Abstract

Researchers from the AbramsonCancer Center of the University of Pennsylvaniaannounced today that findings from two large,international clinical trials show unprecedentedsurvival for patients with multiple myeloma, acancer that occurs in the blood-making cells ofbone marrow. The findings show that when theoral drug lenalidomide (REVLIMID®), is taken incombination with the steroid dexamethasone,patients significantly improve by all measures-including a median survival of nearly threeyears - the longest median survival known forthis difficult to treat patient group.

Edward A. Stadtmauer, MD, Director of theAbramson Cancer Center Bone Marrow and Stem CellTransplant Program and lead investigator fromPenn, was part of the U.S. study published todayin the New England Journal of Medicine alongsidea companion study from Europe showing similarresults.

"This study shows that this new class of drugsis a critical advance toward helping address theincrease in the number of diagnoses formyeloma," said Stadtmauer. "While most U.S.cancer diagnoses are decreasing, statistics showthat the number of myeloma diagnoses isincreasing, particularly in younger patients,"said Stadtmauer.

REVLIMID® (lenalidomide) from Celgene, an oralmedication which treats without the ravages ofchemotherapy, is the first in a new class ofmedications called immunomodulatory drugs(IMiDs). It works by attacking both the cancercell and the micro-environment in which it livesin the bone marrow, thereby stopping the cells'ability to adhere to the wall of tissues wherethey will grow. REVLIMID® also inhibits cancercells' ability to hide from the body's naturalkiller cells in the immune system by stoppingangiogenesis - the growth of blood vessels thatpenetrate into and feed cancerous tumors causingthem to proliferate.

In both the US and European studies, patientsfor whom all previous treatments had failed weregiven either lenalidomide plus dexamethasone - apotent synthetic steroid - or dexamethasone withplacebo. These trials were designed toinvestigate the effectiveness and safety ofcyclic dosing ofREVLIMID® at 25mg combined with high-dosesdexamethasone (HDD) compared with placebo andHDD in previously treated patients with multiplemyeloma. A total of 705 patients were enrolledin 97 sites internationally. Patients in bothtrials had been heavily treated prior toenrollment, many having failed three or morerounds of chemo and/or radiation therapy. Inaddition, more than 50 percent of patientsenrolled had undergone stem celltransplantation. In these new studies REVLIMID® plus dexamethasone achieved superior resultscompared to dexamethasone alone regardless ofthe history of treatment, including the mediasurvival of nearly three years. Such positivepatient response suggests that treatment withREVLIMID® early in the course of the disease maybe beneficial. These findings have caused achange in the official physician guidelines formultiple myeloma which were recently updated toadd REVLIMID® as an initial treatment, insteadof waiting until other treatments have failed.

In Europe and the US, REVLIMID® is being used tothreat myeloma. In the US it is also approvedfor a pre-leukemia condition calledmyelodysplastic syndrome (MDS). It is also beingtested in other leukemias, lymphomas, and solidtumors.

"The last five to ten years have been the mostwonderful time to be a physician treatingmultiple myeloma, thanks to advances likelenalidomide," said Stadtmauer. "Twenty, thirtyyears ago, there wasn't much we could do forthese patients. We couldn't really treat thedisease effectively so we tried to treat thesymptoms with only two or three types ofchemotherapy and radiation, which of course havetheir own negative side-effects. Now, we havethis new, highly effective class of drugs withvery low side effects. Before, we hoped for apositive response in patients. Now, we expectone." Adds Stadtmauer, "Thanks to new agentslike lenalidomide, we've been able to convertthis disease from a killer to more of a chronicillness."

The data from these studies were published intwo separate articles in the NEJM, by leadauthors Donna Weber, MD, Associate Professor,Lymphoma/Myeloma of The University of Texas MDAnderson Cancer Center, and Meletios Dimopoulos,MD, Associate Professor, Department of ClinicalTherapeutics at "Alexandra" Hospital, Athens,Greece.

Dr. Stadtmauer does not have anyfinancial ties to Celgene Corporation, the makerof REVLIMID®, but has received honoraria as partof an educational speaker's bureau sponsored byCelgene.

The Abramson Cancer Center (ACC) of theUniversity of Pennsylvania is a national leaderin cancer research, patient care, and education.The pre-eminent position of the Cancer Center isreflected in its continuous designation as aComprehensive Cancer Center by the NationalCancer Institute for 30 years, one of 39 suchCenters in the United States. The ACC isdedicated to innovative and compassionate cancercare. The clinical program, comprised of adedicated staff of physicians, nursepractitioners, nurses, social workers, physicaltherapists, nutritionists and patient supportspecialists, currently sees over 50,000outpatient visits, 3400 inpatient admissions,and provides over 25,000 chemotherapytreatments, and more than 65,000 radiationtreatments annually. Not only is the ACCdedicated to providing state-of-the-art cancercare, the latest forms of cancer prevention,diagnosis, and treatment are available to ourpatients through clinical themes that developedin the relentless pursuit to eliminate the painand suffering from cancer. In addition, the ACCis home to the 300 research scientists who workrelentlessly to determine the pathogenesis ofcancer. Together, the faculty is committed toimproving the prevention, diagnosis andtreatment of cancer.

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