CEPHEUS Trial Results: Daratumumab-VRd in Transplant-Ineligible Myeloma

Saad Z. Usmani, MD, MBA, FACP, FASCO, chief of the myeloma service at Memorial Sloan Kettering Cancer Center, discusses the results and potential impact from the phase 3 CEPHEUS trial (NCT03652064) of daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro) with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma for whom hematopoietic stem cell transplant is not planned as initial therapy.

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0:09 | These results do signify that adding daratumumab to VRd for this patient population, improves the depth of response in terms of overall [minimal residual disease (MRD)] negativity, sustained MRD negativity, and then the [progression-free survival] benefit is in favor of the [daratumumab] VRd arm as well. The [overall survival] appears to be showing a trend in favor of the experimental arm, despite the fact that the study actually enrolled during the height of the COVID pandemic. This complements the use of daratumumab as a quadruplet for this patient population in the frontline setting.

0:53 | Daratumumab has been now utilized in the community for almost a decade. I think it started mostly in the relapse stage and then subsequently in the frontline stage with the MAIA [NCT02252172] clinical trial. So, our community colleagues are used to using daratumumab. Sorry about that. No worries. The subcutaneous formulation utilized in the CEPHEUS trial is very easy to administer in the clinic and and so that will make you know the regimen utility, you know, quite convenient for both patients as well as community doctors,

1:29 | I think quadruplet induction regimens are becoming the mainstay or standard of care for newly diagnosed patients, whether they are transplant eligible or ineligible. And the CEPHEUS trial results complement the use of daratumumab that was already demonstrated to show better survival outcomes in the MAIA clinical trial and now, with the quadruple regimen in this space for the transplant ineligible patients.