Patients with heavily treated multiple myeloma showed rapid and durable responses to a novel treatment combination, according to a recent study published in Blood (July 2017; doi:10.1182/blood-2017-05-785246).
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“The findings from this clinical study complement the results of the POLLUX phase III study, in which a combination of daratumumab with lenalidomide/dexamethasone induced a high overall response rate and significantly reduced the risk for disease progression and death in patients with relapsed or refractory multiple myeloma compared to lenalidomide/dexamethasone,” said Ajai Chari, MD, of Tisch Cancer Institute, Mount Sinai School of Medicine, New York, and colleagues.
In the study, Chari and colleagues evaluated 103 participants with relapsed/refractory myeloma who received two or more lines of previous therapy and were refractory to their last treatment. During the trial, participants received 16 mg/kg daratumumab and 4 mg pomalidomide daily for 21 days of each 28-day cycle, and 40 mg dexamethasone weekly.
The primary outcome was safety, and the secondary outcomes were overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing.
Results of the study indicated that ORR among participants was 60%, including those with double-refractory disease. A total of 8% of participants achieved stringent complete response, and 9% achieved complete response. The clinical benefit rate was 62%.
Median duration of response in participants who responded to the treatment combination was not reached. Researchers noted that almost one-third (29%) of participants with a complete response or better were MRD negative.
Median follow-up lasted 13.1 months. During this time, median progression-free survival was 8.8 months, and median overall survival was 17.5 months. Participants with standard cytogenetic risk had a median progression-free survival of 10.3 months, compared with a median of 3.9 months in those with high-risk disease.
Researchers reported no new safety signals as a result of the triplet combination therapy.
“Further evaluation of daratumumab plus pomalidomide/dexamethasone is underway in the ongoing APOLLO study conducted by the European Myeloma Network,” researchers concluded.—Christina Vogt