The randomised, phase 3 CEPHEUS trial (NCT03652064) evaluated daratumumab plus VRd compared with VRd alone in patients with newly diagnosed MM (n=395). The primary endpoint of MRD-negativity (10-5) plus complete response or better (≥CR) was met, with rates of 60.9% and 39.4% in the daratumumab arm and control arm, respectively (OR 2.37; 95% CI 1.58–3.55; P<0.0001)1 . Now, Prof. Sonja Zweegman (Amsterdam University Medical Centre, the Netherlands) presented an expanded analysis of MRD outcomes2.
At 12 months, MRD-negativity (10-5) plus ≥CR rates were 43.1% and 28.3% in the experimental arm and control arm, respectively. At 48 months, the corresponding rates were 60.9% and 38.4%. Furthermore, MRD-negativity (10-6) plus ≥CR was documented in 22.8% of the participants on daratumumab at 12 months, whereas only 11.1% of the participants without daratumumab in their treatment regimen reached this endpoint.
At 48 months, the daratumumab arm still delivered higher rates for this endpoint than the control arm (45.2% vs 27.3%). Thus, adding daratumumab to VRd improved MRD-negativity across cut-offs, plus ≥CR rates, at all timepoints. “Note that daratumumab almost doubled 12, 24, and 36-month sustained MRD-negativity plus ≥CR rates,” said Prof. Zweegman.
“CEPHEUS is the fifth phase 3 study in newly diagnosed MM demonstrating the beneficial effect of daratumumab added to standard-of-care regimens,” concluded Prof. Zweegman. “The current MRD data further supports daratumumab plus VRd as a standard therapy for patients with previously untreated MM who were transplant-ineligible or for whom transplant was deferred.”
Medical writing support was provided by Robert van den Heuvel.