Myeloma
New Drug Class Could Fill Unmet Need in Treatment
of Multiple Myeloma
A new class of drugs designed to attack malignant plasma cells
could offer patients with multiple myeloma new treatment
options, according to early clinical trials using two anti-CD38
antibodies presented at the 56th ASH Annual Meeting.
The CD38 antigen is commonly expressed on
myeloma cells, and anti-CD38 antibody binding
signals the patient’s immune cells to destroy the
malignant cells.
There are currently three anti-CD38
antibodies being studied for multiple myeloma.
Researchers at the ASH annual meeting presented early trial findings for two of the agents:
Maria-Victoria Mateos,
daratumumab and SAR650984. Each drug met
MD, PhD
safety standards and was shown to be effective – either in combination
with existing treatment regimens or as a single agent – in patients with
relapsed or treatment-resistant disease.
This new class of drug could fill an unmet need in the treatment of
multiple myeloma by potentially addi ng another highly active class of
drugs to the list of treatment options, said Thomas Martin, MD, professor of clinical medicine at the University of California San Francisco, and
lead author on the study evaluating SAR650984. Over the last 10 years,
Dr. Martin noted, immunomodulatory agents (IMiDs) and proteasome
inhibitors have resulted in improved survival in patients with myeloma.
Anti-CD38 antibodies could be a third option for patients – especially for
those with variations of the disease resistant to other novel agents.
“I do think these represent that next ‘blockbuster’ class of myeloma
drugs that has the ability to synergize with other drugs – especially with
the IMiDs,” he said.
Phase 1 Study Evaluates Safety in Daratumumab in
Combination Regimens
While previous research has evaluated daratumumab as a single agent for
patients relapsed or refractory to several earlier lines of therapy, the latest
ongoing study is designed to evaluate the safety, tolerability, and dose
regimen of daratumumab when it is administered in combination with
currently approved treatments for multiple myeloma.
FIGURE Rates of response and disease progression in
patients in the MMY1001 study
The phase 1b multicenter study divided patients into four treatment groups: bortezomib-dexamethasone (VD), bortezomib-thalidomide-dexamethasone (VTD), bortezomib-melphalan-prednisone
(VMP), and pomalidomide-dexamethasone (POM-D). The researchers
then took six patients from each treatment group and administered an
additional dose of 16 mg/kg daratumumab, and planned to eventually
increase the number of patients receiving daratumumab if it was found to
be well tolerated in earlier cycles.
After median treatment duration of 44 days, the investigators evaluated data from 17 patients taking daratumumab and found there was no
unexpected additional toxicity when the