Multiple Myeloma: Phase 3 Study of DARZALEX + VMP Reduced Risk of Disease Progression and Mortality

MedicalResearch.com Interview with:

Dr. Meletios A. Dimopoulos MD Professor and Chairman Department of Clinical Therapeutics University Athens School of Medicine Athens, Greece

Dr. Dimopoulos

DrMeletios A. Dimopoulos MD
Professor and Chairman
Department of Clinical Therapeutics
University Athens School of Medicine
Athens, Greece

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Updated data from the Phase 3 POLLUX trials showed DARZALEX, in combination with lenalidomide and dexamethasone, reduced the risk of disease progression or death by 56 percent, compared to lenalidomide and dexamethasone alone (Hazard Ratio [HR]=0.44; 95 percent CI [0.34-0.55], p<0.0001). After a median follow-up of 32.9 months, the median progression-free survival (PFS) in the DARZALEX arm has not been reached, compared with a median PFS of 17.5 months for patients who received lenalidomide and dexamethasone alone.

DARZALEX in combination with lenalidomide and dexamethasone also significantly increased the overall response rate (ORR) compared to lenalidomide and dexamethasone alone (93 percent vs. 76 percent, p<0.0001), including rates of complete response (CR) or better (55 percent vs. 23 percent, p<0.0001). DARZALEX also showed significantly higher (>3-fold) MRD-negative rates compared to lenalidomide and dexamethasone alone. These data were featured as an oral presentation (Abstract #739) at the 59th American Society of Hematology (ASH) Annual Meeting in early December.

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Combination Therapy With DARZALEX® (daratumumab) Provides Clinical Benefit In Relapsed Myeloma

MedicalResearch.com Interview with:

Dr. Ajai Chari, MD Associate Professor of Medicine Multiple Myeloma Program and Associate Director of Clinical Research Mount Sinai Hospital, New York

Dr. Ajai Chari

Dr. Ajai Chari, MD
Associate Professor of Medicine
Multiple Myeloma Program and
Associate Director of Clinical Research
Mount Sinai Hospital, New York

MedicalResearch.com: What is the background for this study? Would you briefly explain multiple myeloma (How common is it, whom does it chiefly affect, etc.)?

Response: Multiple myeloma is a rare form of blood cancer that occurs when plasma cells grow uncontrollably in the bone marrow. It is estimated that approximately 30,280 people will be diagnosed and 12,590 will die from the disease in the United States in 2017. While some patients with multiple myeloma have no symptoms at all, symptoms can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections. Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as proteasome inhibitors (PIs) and immunomodulatory agents. Therefore, these patients continue to need new options.

The MMY1001 (EQUULEUS) study is a Phase 1b, open-label study assessing daratumumab in combination with multiple backbone regimens for multiple myeloma. In one arm of the study, supporting the recent approval of DARZALEX (daratumumab), the treatment was assessed in combination with pomalidomide and dexamethasone in patients with multiple myeloma who had received a prior PI and an immunomodulatory agent. Data from the study showed that the addition of daratumumab resulted in an overall response rate (ORR) of 59.2 percent (95 percent CI: 49.1 percent, 68.8 percent), with very good partial response (VGPR) achieved in 28.2 percent of patients. Complete response (CR) was achieved in 5.8 percent of patients and stringent CR (sCR) was achieved in 7.8 percent of patients.

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Triplet Therapy Induces Durable Response In Refractory Myeloma

MedicalResearch.com Interview with:
Dr. Ajai Chari MD
Associate Professor
Medicine, Hematology and Medical Oncology
Tisch Cancer Institute
Mount Sinai School of Medicine
New York, NY

Medical Research: What is the background for this study?

Dr. Chari: This is a heavily pretreated population where the median progression free survival (PFS) of the pomalidomide dexamethasone is only 4 months and ORR is only 31%. While the anti CD38 monoclonal antibody daratumumab has single agent has activity in this setting, patients with rapidly progressive disease need combination therapy to achieve rapid and deep responses. Pomalidomide also upregulates CD38 on MM cells and like daratumumab, increases the effector cell activity against myeloma. Thus, there is a strong preclinical and clinical rationale for combining daratumumab with pomalidomide and dexamethasone.

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