Daratumumab is a fully human monoclonal antibody that binds to a novel target on myeloma cells.

POLLUX was an open-label, randomised phase 3 study conducted in 18 countries that evaluated the combination of daratumumab and lenalidomide and dexamethasone (daratumumab group) compared with lenalidomide and dexamethasone (control group) in 569 patients with relapsed or refractory multiple myeloma who received at least 1 prior line of therapy.

At the pre-planned interim analysis, an unprecedented 63% reduction in the risk of progression or death was shown in the daratumumab group compared with control group, leading to early unblinding of the study.

More patients achieved an overall response in the daratumumab group compared with the control group (93% vs 76%, P <0.0001).

Deep and durable responses were significantly more frequent in the daratumumab group, with higher rates of very good partial response or better (76% vs 44%, P <0.0001) and a more than doubling of complete response or better (43% vs 19%, P <0.0001).

Treatment was well-tolerated in the daratumumab group with adverse events consistent with the known profiles of the drugs in the combination.

The study establishes a positive benefit/risk profile for daratumumab with lenalidomide and dexamethasone in multiple myeloma patients who have received at least 1 prior line of therapy and suggests that this combination may represent a new standard of care for these patients.

Source: EHA