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ASCO 2026 | 76-month follow-up data from the CEPHEUS trial: Dara-VRd in newly diagnosed myeloma
Saad Usmani, MD, MBA, FRCP, FASCO, FACP, Memorial Sloan Kettering Cancer Center, New York, NY, discusses the 76-month follow-up data from the Phase III CEPHEUS trial (NCT03652064), which evaluated the efficacy of daratumumab in combination with bortezomib, lenolidomide, and dexamethasone (Dara-VRd) in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
So the CEPHEUS clinical trial is the Phase III clinical trial that led to the approval of dara-RVd for the transplant ineligible patients in the newly diagnosed setting. And so this analysis looks at the 76-month follow-up data in terms of depth of response as well as progression-free survival. When I say depth of response, the primary endpoint for the clinical trial was MRD-negative CR rates overall...
So the CEPHEUS clinical trial is the Phase III clinical trial that led to the approval of dara-RVd for the transplant ineligible patients in the newly diagnosed setting. And so this analysis looks at the 76-month follow-up data in terms of depth of response as well as progression-free survival. When I say depth of response, the primary endpoint for the clinical trial was MRD-negative CR rates overall. And then we also had sustained MRD negativity at 12 and 24 months and PFS as important secondary endpoints. And so after 76 months of follow-up, the median PFS in the dara-VRd arm has still not been reached, which is quite impressive for this patient population, whereas the median on the VRd arm is about 50 months or so. And then if we look at the safety signal, it appears to be, you know, very similar to what had been previously reported. No new safety signals were seen. If we look at the MRD negativity rates, significantly higher in the experimental arm for both overall as well as MRD negative CR rate at 12 months or beyond and sustained MRD negativity at even 24 months or beyond. About a third or more of the patients actually sustained that response. And the OS was still trending in favor of the quadruplet induction regimen. So, you know, these data just reassure us that the standard of care opportunities or the data is, you know, as standard of care for quadruplet regimens, you know, is here to stay. And it’s a very important benchmark that we have to work to accomplish with newer regimens as well as exceed without compromising safety.
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