Daratumumab demonstrates efficacy against multiple myeloma5 Jun 2016
Initial findings from a pivotal phase 3 trial showed that daratumumab added to a standard two-drug regimen (bortezomib and dexamethasone) markedly improved outcomes for patients with recurrent or refractory multiple myeloma. Daratumumab, the first monoclonal antibody approved for multiple myeloma, targets a protein on the surface of cancer cells called CD-38.
“These results are unprecedented in this cancer”
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%.
“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, a 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.”
Daratumumab is one of the first drugs with the ability to directly kill myeloma cells and at the same time stimulate the immune system response to attack the tumor. The direct effect explains rapid tumor shrinkage, whereas the immune effect sustains prolonged responses to the treatment. The US FDA granted daratumumab accelerated approval in November 2015 based on results from a non-randomized phase 2 trial.
Slower tumor growth and better quality of life
This first randomized clinical trial of daratumumab included nearly 500 patients with relapsed or refractory multiple myeloma. Patients received 8 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 haematologic toxicity, infections, and peripheral neuropathy.
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.Source: eCancer News