Examining Safety: Daratumumab With 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 safety data from the phase 3 CEPHEUS trial (NCT03652064) evaluating 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.

According to findings presented at the 21st International Myeloma Society Annual Meeting, the addition of daratumumab and hyaluronidase-fihj to the VRd regimen improved minimal residual disease (MRD) negativity rates compared with VRd alone in this patient population.

For safety, grade 3/4 treatment-emergent adverse effects (TEAEs) were seen among 92.4% of patients in the daratumumab arm compared with 85.6% of patients in the VRd arm. TEAEs led to discontinuation of all study drugs in 7.6% and 15.9% of patients, respectively.

Moreover, grade 5 non–COVID-19 TEAEs were seen in 10.7% of patients in the experimental group vs 7.7% of patients in the control group. Between arms, the exposure-adjusted grade 5 TEAE rate was 0.39/100 vs 0.31/100 for the control arm.

Transcription:

0:09 | So, hematologic [adverse] effects typically are the most common ones that we observe in patients with newly diagnosed multiple myeloma, and there was, overall, a higher proportion of patients with those [adverse] effects in the daratumumab-containing arm compared with the VRd alone arm. But the duration of treatment on the [daratumumab] VRd arm was also almost 2 years longer than VRd, so you have to kind of take that into account.

0:47 | The infections were the other feature. But again, in terms of the upper respiratory tract infections that were grade 3 or higher, those numbers were similar in the study. So was peripheral sensory neuropathy.