Second part of the phase III CASSIOPEIA study meets its primary endpoint

Positive topline results from the second part of the phase III CASSIOPEIA (NCT02541383) study were announced on October 21, 2020.

The first part of the CASSIOPEIA study aimed to compare daratumumab (Dara), an anti-CD38 antibody, plus bortezomib (V), thalidomide (T), and dexamethasone (d) versus VTd alone in 1,085 transplant-eligible patients with newly diagnosed multiple myeloma. The quadruplet was well tolerated and provided significant clinical benefit compared with VTd in this population of patients (read the full results here).

The second part of the study evaluated Dara as maintenance treatment (16 mg/kg every 8 weeks, for up to 2 years) versus no treatment (observation) in patients who achieved a response; the primary endpoint of this second part was progression-free survival (PFS).

This second part met its primary endpoint of improving PFS at a pre-planned interim analysis (HR, 0.53; 95% CI, 0.42–0.68; p < 0.0001), with a reduction in the risk of progression or death in patients who received Dara of 47%. The safety profile was consistent with the known Dara safety profile.