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Anti-CD38 monoclonal antibodies, such as daratumumab and SAR650984, have emerged as potential treatments for patients with multiple myeloma. Data has demonstrated promise for these therapies both as single-agents and in combination with lenalidomide. Moreover, these treatments appear to be well tolerated, with infusion reaction as the primary adverse event, explains Jeffrey A. Zonder, MD.
In May 2013, single-agent daratumumab received a breakthrough therapy designation from the FDA as a treatment for patients with multiple myeloma following two lines of therapy. In combination with lenalidomide and dexamethasone, daratumumab demonstrated an overall response rate (ORR) of 75%. In an expansion cohort of patients who received daratumumab at the maximum-tolerated dose of 16 mg/kg, the ORR was 92.3%.
In a phase Ib trials, SAR650984 in combination with lenalidomide and dexamethasone demonstrated an ORR of 58%, with a clinical benefit rate of 65%, including a 6% stringent complete response rate. In patients receiving the 10-mg/kg dose, the ORR was 63%.
Clinical trials continue to assess novel treatment approaches for patients with multiple myeloma, including PD-1 inhibitors, peptide vaccines, and kinase inhibitors. With the growing number of agents, the next hurdle to overcome will be costs, the panelists agree.