The US Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).
MM is a form of cancer due to abnormal and uncontrolled growth of plasma cells in the bone marrow. The most common symptom is anemia, which can be associated with fatigue and shortness of breath. Other features of the condition may include multiple infections, abnormal bleeding, bone pain, weak and/or easily broken bones, and numbness and/or weakness of the arms and legs. The exact underlying cause of MM is currently unknown.
D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. The Phase 3 CEPHEUS (NCT03652064) clinical trial was a multicenter, randomized, open-label study evaluating the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) in MM patients who were ineligible for ASCT or deferred ASCT as initial therapy. D-VRd now has 11 indications for MM, including 5 for firstline therapy in newly diagnosed patients with MM. The therapy can now be used in newly diagnosed patients who are eligible or ineligible for ASCT.
CEPHEUS results showed that at a median follow-up of 22 months, the overall MRD-negativity rate at a sensitivity of 10^-5 was 52.3% with D-VRd versus 34.8% with VRd. At a median follow-up of 39 months, the proportion of patients achieving sustained MRD-negativity of 12 months or greater was 42.6% with D-VRd versus 25.3% with VRd. Treatment with D-VRd also significantly reduced the risk of progression or death by 40%. At a median follow-up of 59 months, D-VRd significantly increased the depth of response with higher rates of complete response or better at 81.2% versus 61.6% with VRd.
The safety profile of D-VRd were consistent with adverse events seen for daratumumab and hyaluronidase and VRd separately. The most common adverse events were upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising.
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To learn more about MM and other rare cancers, visit https://checkrare.com/diseases/cancers/
