Saturday, July 13, 2024

Multiple Myeloma Outcomes Significantly Improved by DARZALEX® Regimens, Announces Johnson & Johnson

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Johnson & Johnson announced that DARZALEX® (daratumumab)-based regimens significantly improve outcomes in both transplant-eligible and ineligible patients newly diagnosed with multiple myeloma. In the Phase 3 PERSEUS study, 88% of transplant-eligible patients achieved a complete response, with 47% maintaining MRD-negativity for over a year using DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based regimens.

The PERSEUS study demonstrated that DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) followed by maintenance with DARZALEX FASPRO® and lenalidomide (D-R) resulted in deeper responses and higher rates of MRD negativity compared to VRd alone. The D-VRd arm had higher complete response rates and sustained MRD negativity at both 10-5 and 10-6 levels, showing significant improvement in progression-free survival (PFS).

The Phase 3 MAIA study showed a median overall survival of 7.5 years with DARZALEX® plus lenalidomide and dexamethasone (D-Rd), the longest reported for transplant-ineligible patients with newly diagnosed multiple myeloma. This regimen reduced the risk of death by 33% compared to lenalidomide and dexamethasone (Rd) alone, showcasing consistent benefits across various subgroups.

Multiple Myeloma Outcomes Improved by DARZALEX® in Long-term CASSIOPEIA Study

Long-term follow-up from the CASSIOPEIA study indicated that post-transplant maintenance with DARZALEX® significantly reduced disease progression or death risk by 51% versus observation. The safety profiles in the PERSEUS, MAIA, and CASSIOPEIA studies were consistent with known profiles for DARZALEX® and DARZALEX FASPRO®.

The PERSEUS study, conducted in collaboration with the European Myeloma Network, compares the efficacy and safety of D-VRd followed by D-R maintenance versus VRd followed by R maintenance in transplant-eligible patients. The primary endpoint is PFS, with secondary endpoints including overall response rate, MRD-negativity, and overall survival.

The MAIA trial included 737 newly diagnosed patients ineligible for transplant, demonstrating significant overall survival benefits with D-Rd. The CASSIOPEIA trial, involving 1,085 patients, compared DARZALEX® in combination with bortezomib, thalidomide, and dexamethasone (VTd) versus VTd alone, followed by a second randomization to maintenance therapy with DARZALEX® or observation.

Multiple Myeloma

Multiple Myeloma Treatments DARZALEX® and DARZALEX FASPRO® Show Promising Outcomes Amid High Risks

Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow, characterized by malignant plasma cell proliferation. It remains incurable, with an estimated 35,000 new cases and 12,000 deaths in the U.S. in 2024. Patients have a 5-year survival rate of 59.8%. Common symptoms include bone pain, fractures, anemia, fatigue, and infections.

DARZALEX FASPRO®, approved in 2020, is indicated for multiple myeloma in combination with other therapies. DARZALEX®, approved in 2015, was the first CD38-directed antibody for multiple myeloma treatment. It is recommended by the National Comprehensive Cancer Network (NCCN) for various multiple myeloma settings.

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DARZALEX® and DARZALEX FASPRO® have associated risks, including infusion-related reactions, neutropenia, thrombocytopenia, and interference with serological testing. Proper pre-medication and monitoring are essential to manage these risks effectively. Johnson & Johnson continues to advance healthcare innovations through its expertise in innovative medicine and medtech. The company’s efforts aim to prevent, treat, and cure complex diseases, with a focus on delivering breakthrough treatments and personalized healthcare solutions.


Resource: Johnson & Johnson, June 03, 2024

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