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ASH 2014: Daratumumab plus standard treatment improves outcomes in relapsed, hard-to-treat multiple myeloma in phase I study

6 Dec 2014
ASH 2014: Daratumumab plus standard treatment improves outcomes in relapsed, hard-to-treat multiple myeloma in phase I study

A new class of drugs called anti-CD38 antibodies target multiple myeloma cells by binding to an antigen (CD38) expressed on the myeloma cell and then signalling the patient’s immune cells to attack myeloma cells.

Daratumumab, one of three anti-CD38 antibodies under investigation for multiple myeloma, has been reported in early trials to be effective and relatively safe as a single agent in patients with relapsed or treatment-resistant disease.

Given these positive results, researchers hypothesised that they could potentially improve response rates for these patients by adding daratumumab to already-proven treatment regimens.

To study the safety, tolerability, and appropriate dose regimen of daratumumab in combination with standard treatment, researchers enrolled patients with newly diagnosed, relapsed, or treatment-resistant multiple myeloma in a multi-center trial in which they received daratumumab with one of four standard regimens.

Standard regimens included bortezomib-dexamethasone (VD), bortezomib-thalidomide-dexamethasone (VTD), bortezomib-melphalan-prednisone (VMP), and pomalidomide-dexamethasone (POM-D). After median treatment duration of 44 days, tolerability assessments for 17 patients in the newly diagnosed multiple myeloma group receiving a bortezomib-based regimen (VD, VTD, or VMP) indicated that patients experienced no additional toxicity.

Four patients experienced infusion-related reactions associated with daratumumab; however, this did not interrupt treatment. All other adverse events were consistent with those accompanying standard regimens. Preliminary data demonstrate a high patient response rate to this new therapeutic approach. Efficacy and safety assessments in the trial are ongoing and will be presented at the meeting.

“This is a very new and exciting concept in multiple myeloma, as we are seeing that combining this precision approach with the standard of care is leading to more effective treatment without increased toxicity,” said lead study author Philippe Moreau, MD, of University Hospital of Nantes in France.

“By targeting a simple molecule expressed by the cancer cells, this therapy has the potential to become a potent addition to conventional treatment.”

Watch the press conference and the interview for more.

Source: ASH