Recurrent B Acute Lymphoblastic Leukemia

SEATTLE, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced today that the new Medicare Clinical Laboratory Fee Schedule (CLFS) rate for its next-generation sequencing (NGS)-based clonoSEQ® test for minimal – or measurable – residual disease (MRD) assessment is now in effect as of January 1, 2025. The CLFS rate for clonoSEQ (PLA 0364U) was set at $2,007, consistent with the final gapfill rate recommendation for the test. The CLFS, managed by the Centers for Medicare & Medicaid Services (CMS), establishes payment rates for lab tests covered by Medicare. Novel diagnostic laboratory tests like clonoSEQ, for which there is no existing comparable test, undergo a special pricing process known as gapfill determination. In this process, Medicare assesses the test’s value by considering factors such as the resources required to perform the test, rates paid for the test by other payers, rates paid for tests leveraging similar technologies, and additional unique attributes of the test. After a year of evaluation, CMS finalizes a national rate to ensure that essential tests like clonoSEQ are fairly priced and accessible to patients who need them. Many other payers in the US look to the Medicare CLFS in establishing their rate schedules for diagnostic tests that they cover. As previously announced, MolDX has also updated clonoSEQ episode pricing to $8,029, in line with this new CLFS rate across all covered indications, including multiple myeloma, chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, circulating tumor DNA-based MRD testing in diffuse large B-cell lymphoma and mantle cell lymphoma. “Finalizing the Medicare reimbursement rate for clonoSEQ through the gapfill process represents another key milestone and highlights the value of the test in patient care,” said Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies. “MRD testing provides clinicians with essential insights into a patient’s disease status and response to therapy. With the newly defined rate, we look forward to driving broader adoption by healthcare providers and private insurers, expanding accessibility for patients living with blood cancers." The clonoSEQ test provides accurate and sensitive measurement of MRD in lymphoid malignancies and is widely covered by both Medicare and commercial payers for patients with lymphoid cancers. With the completion of the CLFS pricing process for clonoSEQ, Adaptive plans to leverage the finalized rate in the process of establishing new payer agreements, updating existing agreements to include the clonoSEQ PLA code, and expanding coverage to additional indications. About clonoSEQ clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, ALL, DLBCL and MCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary. About Adaptive BiotechnologiesAdaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com

The annual meeting of the American Society of Hematology was held from Dec. 7 to 10 in San Diego and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems. In one study, Kristin A. Shimano, M.D., of the University of California, San Francisco, Benioff Children's Hospital, and colleagues found that for pediatric patients with newly diagnosed immune thrombocytopenia (ITP) within three months of diagnosis, eltrombopag leads to a more durable platelet response during weeks six 6 to 12 of treatment compared with standard treatments. The authors evaluated the use of eltrombopag (a thrombopoietin receptor agonist approved for persistent or chronic ITP) during the new-diagnosis phase and compared the responses between patients treated with eltrombopag and standard therapies (intravenous immunoglobulin, prednisone, and anti-D globulin). The researchers found that compared with those treated with standard therapies, a greater proportion of patients treated with eltrombopag had a platelet count of more than 50,000 during weeks 6 through 12 of the study without requiring a rescue therapy. "This has a huge potential to change our approach to the management of newly diagnosed pediatric ITP," Shimano said. "For patients with moderate bleeding or significant impact on quality of life due to their ITP, eltrombopag may be a good option to get the platelets to a more hemostatic level during the time that they have active ITP." Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Novartis, which manufactures eltrombopag and funded the study. Abstract No. 709 In another study, Rushad Patell, M.D., of Harvard Medical School in Boston, and colleagues found that the use of glucagon-like peptide-1 (GLP-1) receptor agonists leads to a significant reduction in the risk for blood clots among patients with type 2 diabetes. The authors compared patients who newly started a GLP-1 receptor agonist for type 2 diabetes to patients being prescribed another antidiabetic medication to assess rates of blood clots at one year. The researchers observed a 20 percent reduction in venous thromboembolism rates at 12 months. This benefit was seen across patients with different body mass index at the time of starting the study and included a breakdown for the two different types of blood clots (pulmonary embolism and deep vein thrombosis) when evaluated individually. "This was the first time this medication has been shown to impact venous thromboembolism to our knowledge," Patell said. "If these results are confirmed, they suggest that the use of these medications can have benefits beyond what has already been shown and can now include a reduction of blood clots." Two authors disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 701 Jenny Paredes, Ph.D., of the City of Hope National Medical Center in Duarte, California, and colleagues found that increasing dietary fiber intake is beneficial for the intestinal microbiome of allogeneic hematopoietic cell transplantation (allo-HCT) patients and could lead to an increase in overall survival and a reduction in acute graft-versus-host disease (GVHD). The authors assessed a preclinical mouse model of GVHD with defined diet fiber concentrations and also analyzed the dietary patterns of allo-HCT patients. The investigators found that dietary fiber intake in allo-HCT patients (days −7 to −30) positively correlated with higher overall survival, lower acute GVHD cumulative incidence, and lower gastrointestinal-GVHD cumulative incidence (landmark analysis to 24 months). In addition, fiber consumption positively correlated with microbial alpha-diversity, relative abundance of butyrate producers, and production of short chain fatty acids (SCFAs). In the murine model of GVHD post allo-HCT, the researchers determined that a diet rich in fiber (12 percent cellulose) increased survival to GVHD, led to a higher relative abundance of butyrate producers, and modulated gene expression associated with higher epithelial homeostasis and lower T-cell mediated inflammation (single cell sequencing). "Although follow-up studies on the strategies that can be used to increase dietary fiber in allo-HCT patients are in course, we would like to recommend reevaluating the nutritional plans and meals for allo-HCT patients and including multiple options of high fiber foods for every meal and beverage," Paredes said. "Increasing fiber consumption by 10 to 20 grams per day, based on our results, would lead to a more diverse microbiome, an increase in SCFA production, and consequently, to better overall survival (the Recommended Dietary Allowance for dietary fiber by the U.S. Department of Agriculture is 25 to 30 grams per day)." One author disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 259 ASH: Blinatumomab + Chemo Aids Survival in B-Cell Acute Lymphoblastic Leukemia THURSDAY, Dec. 12, 2024 -- For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Reduced-Dose Anticoagulants Not Noninferior for Recurrent VTE FRIDAY, Dec. 6, 2024 -- Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Auto-HCT Not Beneficial for Mantle Cell Lymphoma With Undetectable Residual Disease FRIDAY, Dec. 6, 2024 -- Autologous hematopoietic cell transplant is not beneficial for patients with mantle cell lymphoma in first complete remission with undetectable minimal residual disease, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Complications Common With Controlled Ovarian Hyperstimulation in Sickle Cell Anemia THURSDAY, Nov. 14, 2024 -- Many individuals with sickle cell anemia undergoing controlled ovarian hyperstimulation with oocyte cryopreservation have complications, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text ASH: GLP-1 RA Use Tied to Lower Rate of Venous Thromboembolism in Diabetes THURSDAY, Nov. 14, 2024 -- For patients with type 2 diabetes mellitus, glucagon-like peptide 1 receptor agonist use is associated with a lower risk for venous thromboembolism, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

THURSDAY, Dec. 12, 2024 -- For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia (ALL) with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Sumit Gupta, Ph.D., from the University of Toronto, and colleagues conducted a phase 3 trial involving children with newly diagnosed standard-risk B-cell ALL who had an average or high risk for relapse. A total of 1,440 patients were randomly assigned to receive chemotherapy alone or chemotherapy plus blinatumomab; the results from the first interim efficacy analysis, which included 722 and 718 patients, respectively, were reviewed. The researchers found that the estimated three-year disease-free survival was 96.0 ± 1.2 percent with blinatumomab and chemotherapy and 87.9 ± 2.1 percent with chemotherapy alone at a median follow-up of 2.5 years (difference in restricted mean survival time, 72 days). Among patients with an average relapse risk, the estimated three-year disease-free survival was 97.5 ± 1.3 percent with blinatumomab and chemotherapy and 90.2 ± 2.3 percent with chemotherapy alone; the corresponding values were 94.1 ± 2.5 percent and 84.8 ± 3.8 percent, respectively, among those with a high relapse risk. "The addition of blinatumomab to standard chemotherapy resulted in a significant improvement in disease-free survival," the authors write. "This improvement was consistent across subgroups defined according to patient-related or disease-related characteristics." Several authors disclosed ties to pharmaceutical companies, including Amgen, which manufactures blinatumomab and contributed funding for the study.