Multiple Myeloma

Atlanta, GA—MLN9708, an investigational oral proteasome inhibitor, produced impressive results in a phase 1/2 clinical trial of treatment-naïve patients with multiple myeloma that was featured in a press briefing at the 2012 American Society of Hematology (ASH) meeting.

Used in combination with lenalidomide, MLN9708 achieved an overall response rate exceeding 90%, and complete responses were seen in 25% of patients, reported Shaji K. Kumar, MD, Professor of Medicine at the Mayo Clinic, Rochester, MN.

Chicago, IL—The novel immuno­modulatory drug (IMiD) pomalidomide showed strong activity in patients with multiple myeloma who are not responding to current therapies, said Irene Ghobrial, MD, medical staff member in the Myeloma Program of the Dana Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School, Boston.

“As myeloma patients live longer and longer, they need new agents of therapy, and pomalidomide may be one of those,” said Dr Ghobrial, who presented the results of this phase 2 clinical trial during ASCO 2012.

Chicago, IL—The first oral proteasome inhibitor to enter clinical investigation in multiple myeloma is MLN9708. The data from a phase 1 clinical trial presented at ASCO 2012 suggest that this drug encourages disease control and durability of re­sponses in heavily pretreated patients with multiple myeloma.

The first-generation proteasome inhibitor bortezomib changed the treatment paradigm of multiple myeloma. Data are now maturing for the next-generation agent carfilzomib, with US Food and Drug Administration approval expected soon. Several novel agents in this class are also in the pipeline. These second-generation agents appear to be as effective as bortezomib but less neurotoxic, according to studies presented at ASH 2011.

The final analysis of the phase 3 VISTA trial upheld a persistent and significant survival benefit for bortezomib in patients with previously untreated multiple myeloma.  

Of the 655 patients in VISTA, those treated with bortezomib lived an average of 13.3 months longer than those receiving a regimen lacking this agent, VISTA investigator Jesús F. San Miguel, MD, PhD, of the Hospital Clinico Universitario, Salamanca, Spain, reported.

The value of continuous, or maintenance, therapy in pa­tients newly diagnosed with multiple myeloma who are not eligible for stem-cell transplant (such as the elderly) is still debated. Studies presented at ASH 2011 showed that maintenance therapy can delay disease progression, although an overall survival (OS) advantage is not yet evident.

Early-phase studies of the new immunomodulatory drug poma­lidomide drew considerable interest at ASH 2011 and generated enthusiasm from myeloma specialists.

Paul G. Richardson, MD, of Dana-Farber Cancer Institute, Boston, who has led trials of pomalidomide, commented, “Over 40% clinical benefit rate and almost 17 months median survival in heavily pretreated patients is fantastic.”

Elotuzumab, a humanized IgG1 monoclonal antibody, led to very high response rates and prolonged remissions in 73 patients with relapsed multiple myeloma or refractory to previous treatment in a phase 2 study presented by Sagar Lonial, MD, of Emory University School of Medicine, Atlanta.

Patients who received elotuzumab (10 or 20 mg/kg) in combination with lenalidomide and low-dose dexameth­asone had an 82% overall response rate. Response rates exceeded 90% in patients who had received 1 previous therapy and those who received the lower dose.  

Treatments for multiple myeloma have advanced rapidly over the past 15 years as research has fostered an improved understanding of the mechanisms of the disease. These discoveries have been translated into effective drugs, most notably bortezomib (Velcade), thalidomide (Thalomid), and lenalidomide (Revlimid).

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