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ASH 2017: Subcutaneous Delivery of Daratumumab in Relapsed or Refractory Myeloma

By: Meg Barbor, MPH
Posted: Thursday, December 14, 2017

In patients with relapsed or refractory multiple myeloma, subcutaneous administration of daratumumab in combination with recombinant human hyaluronidase enzyme (rHuPH20) was well tolerated, with infusion-related reaction rates lower than those observed with intravenous daratumumab. These updated data from the PAVO trial were presented by Ajai Chari, MD, of Tisch Cancer Institute, Mount Sinai School of Medicine, New York, and colleagues, at the 2017 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 838). This alternative dosing method is being compared with the approved intravenous method in an actively enrolling phase III study in this patient population.

Data from part 2 of this open-label, multicenter, dose-escalation phase 1b study showed that infusion-related reactions were lower than expected in all groups, particularly in those treated with 1800 mg of subcutaneous daratumumab administered over 3 to 5 minutes, the investigators reported. Infusion-related reactions were observed in 4% of patients who received that dose, and no grade 3/4 reactions were observed.

Daratumumab—currently approved as monotherapy and in combination with bortezomib or immunomodulatory drugs in patients with relapsed or refractory multiple myeloma—is typically administered intravenously. It has been associated with infusion-related reactions in 46% of patients, Dr. Chari and colleagues noted.