The CEPHEUS trial, a phase 3 study, investigated the efficacy and safety of adding daratumumab to lenalidomide and dexamethasone (DRd) compared to lenalidomide and dexamethasone (Rd) alone in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). Initial assessments of the trial data are focusing on the clinical impact and potential changes to treatment paradigms for this patient population.
The study's primary endpoint was progression-free survival (PFS). While detailed results are pending full publication, the addition of daratumumab to Rd showed an improvement in PFS. However, clinicians are weighing this benefit against the increased toxicity associated with the triplet regimen, including higher rates of hematologic adverse events and infections.
"The key question is whether the added benefit of daratumumab justifies the increased toxicity and cost," noted one expert. The current standard of care for transplant-ineligible NDMM often involves Rd, and the CEPHEUS data prompts a reassessment of this approach. Factors such as patient frailty, comorbidities, and access to resources will likely influence treatment decisions.
Furthermore, the evolving landscape of NDMM treatment, with the availability of other novel agents and combinations, adds complexity to the decision-making process. Clinicians are considering how DRd compares to other regimens in terms of efficacy, safety, and patient convenience. The full data from the CEPHEUS trial, including subgroup analyses and long-term follow-up, will be crucial in refining treatment strategies for transplant-ineligible NDMM patients.
