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ASCO 2016: Adding Daratumumab to Bortezomib and Dexamethasone Markedly Improves Outcomes in Recurrent/Refractory Multiple Myeloma

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Key Points

  • The daratumumab combination reduced the risk of cancer progression by 70% and doubled both very good partial response rates from 29% to 59% and complete response rates from 9% to 19%.
  • According to the study author, in many cases, tumors shrank in just a month. As a result of shrinkage and slower tumor growth, patients had less pain and a better quality of life.
  • Patients in the daratumumab group experienced slightly higher rates of hematologic toxicity, infections, and peripheral neuropathy.

Initial findings from a pivotal phase III trial showed that daratumumab (Darzalex) added to a standard two-drug regimen (bortezomib [Velcade] and dexamethasone) markedly improved outcomes for patients with recurrent or refractory multiple myeloma.

The daratumumab combination reduced the risk of cancer progression by 70% and doubled both very good partial response rates from 29% to 59% and complete response rates from 9% to 19%. Daratumumab, the first monoclonal antibody approved for multiple myeloma, targets a protein on the surface of cancer cells called CD-38.

These data were presented by Palumbo et al at the Plenary Session of the 2016 ASCO Annual Meeting (Abstract LBA4).

“We’ve suspected for a long time that CD-38 is the major treatment target for multiple myeloma, but these results are unprecedented in this cancer,” said lead study author Antonio Palumbo, MD, Chief of the Myeloma Unit at the Department of Oncology, University of Torino in Torino, Italy. “It’s clear now that we’ll be moving to a three-drug regimen with daratumumab as the standard of care.”

About the Study

This first randomized clinical trial of daratumumab included nearly 500 patients with relapsed or refractory multiple myeloma. Patients received eight cycles of either regimen, followed by daratumumab maintenance therapy for patients in the daratumumab group.

“Daratumumab is a fast-acting drug—in many cases, tumors shrank in just a month. As a result of shrinkage and slower tumor growth, patients had less pain and a better quality of life,” said Dr. Palumbo.

He noted that daratumumab did not substantially worsen the most common side effects of the standard regimen. Patients in the daratumumab group experienced slightly higher rates of hematologic toxicity, infections, and peripheral neuropathy.

Next Steps

Longer patient follow-up is needed to determine the impact of this daratumumab combination on patient survival. A clinical trial that combines daratumumab with another standard therapy for recurrent multiple myeloma is underway. Additional clinical trials are testing various daratumumab-based regimens for patients with newly diagnosed multiple myeloma.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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