Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

RARITAN, NJ, June 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the first randomized Phase 3 study investigating subcutaneous daratumumab[i] in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.[1],[2] The data demonstrated subcutaneous daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate (CR), (53 percent vs. 18 percent [P<0.0001]), compared to CyBorD. Additionally, treatment with D-CyBorD delayed the time to major organ deterioration progression-free survival (MOD-PFS), and enhanced event-free survival (MOD-EFS) based on MOD-PFS criteria with the time to initiation of next therapy. The combination showed a safety profile consistent with subcutaneous daratumumab or CyBorD alone.[3] The positive results are being highlighted during a press briefing at the 25th EHA Annual Congress today and will be presented during a late-breaking oral session on Sunday, June 14 at 8:30 a.m. ET (Abstract LB2604). AL amyloidosis is a rare and potentially fatal multi-system disorder that occurs when bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form an amyloid. This amyloid is deposited in tissues and vital organs and interferes with normal organ function.1,2 As the disease progresses, many patients experience gradual deterioration...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news