Company: ADPT
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030913
Chunk: 14

Company: Adaptive Biotechnologies Corp
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1
Chunk 14
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 efficacy and safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) or VRd in patients with newly diagnosed MM who are transplant ineligible. Data presented at the 21st International Myeloma Society Annual Meeting (Usmani et al 2024) showed that the MRD negativity rate at 10-5 as measured by clonoSEQ was significantly higher with D-VRd versus VRd (60.9% versus 39.4%), meeting the primary endpoint of the study at a median follow-up of 58.7 months. The D-VRd arm also demonstrated higher rates of sustained MRD-negativity, progression free survival, and overall survival ("OS"). If approved, this new indication for daratumumab would be the first FDA-approved treatment regimen for newly diagnosed MM based on a study with MRD-negativity as the primary endpoint.

•Data from the FELIX study indicate that achieving deep molecular remission, defined as MRD levels below 10⁻⁶, correlates with improved outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel. These findings were presented at the American Society of Hematology ("ASH") annual meeting in 2024 in an oral session titled Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes. The study found that 84% of treatment responders who had a clonoSEQ MRD test achieved MRD <10⁻⁶. This result was associated with more durable responses, and higher event-free survival and OS rates than those observed in patients with MRD ≥10-4 and between 10-4 and 10-6. 

•Phase 3 data from the ECOG-ACRIN EA4151 trial indicate that autologous hematopoietic cell transplantation (auto-HCT) may not provide additional benefit for MCL patients in first complete remission (CR) who have undetectable minimal residual disease (uMRD) at a sensitivity of 10⁻⁶. The findings were presented at ASH 2024 in a late-breaking abstract titled, Lack of Benefit of Autologous