Novel Multiple Myeloma Regimen Slows Disease Progression

Bortezomib and dexamethasone slowed disease progression in patients with recurrent or refractory multiple myeloma.

A pivotal phase 3 trial showed that daratumumab (Darzalex) used in combination with the 2 drug regimen of bortezomib and dexamethasone slowed disease progression in patients with recurrent or refractory multiple myeloma.

The findings will be presented at the Annual Society of Clinical Oncology’s (ASCO) Plenary Session.

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

The study enrolled 500 randomized patients with relapsed or refractory multiple myeloma. Patients were given either of the regimens for 8 cycles, followed by Darzalex maintenance therapy in the daratumumab arm.

The results of the study showed that combination regimen reduced the risk of cancer progression by 70%. Furthermore, very good partial response rates jumped from 29 to 59% and complete response rates increased from 9 to 19%.

Darzalex is the first FDA-approved monoclonal antibody to treat multiple myeloma. The drug works by targeting the CD-38 protein on the surface of cancer cells.

“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,” Palumbo said. “It’s clear now that we’ll be moving to a 3 drug regimen with daratumumab as the standard of care.”