Epoetin beta

Pictured: Bristol Myers Squibb in NJ/iStock, arlutz73 Bristol Myers Squibb is advancing towards its $4 billion-plus sales aspirations for Reblozyl with another indication added to its label. Monday, BMS announced that the FDA bumped up the therapy to a first-line treatment option for anemia in adults with low- to intermediate-risk myelodysplastic syndromes who may require regular blood transfusions. Reblozyl, a recombinant fusion protein designed to suppress the Smad2/3 signaling pathway to increase red blood cell counts, was first authorized in 2019 for anemia in beta-thalassemia. The therapy, co-marketed with Merck, was approved for myelodysplastic syndromes (MDS)-related anemia in 2020 but only in patients who had failed to respond to an erythropoiesis-stimulating agent (ESA), the historically front-line treatment. The label expansion was backed by data from the Phase III COMMANDS study, which put BMS’ therapy head-to-head with the ESA standard of care treatment. Over 58% of patients treated with Reblozyl achieved transfusion independence compared to 31% of patients receiving epoetin alfa, the ESA drug manufactured by Amgen and Johnson & Johnson marketed as Epogen and Procrit, respectively. The trial also proved the drug was effective in patients with and without ring sideroblasts—blood cells with iron deposits circling the nucleus. Previous approval had limited the drug’s use to MDS patients exhibiting this common symptom. “Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia,” according to the company’s press release. BMS has high hopes for the therapy. Second-quarter 2023 sales came in at $234 million. As the company works to add more indications to the drug’s label, BMS is projecting sales of over $4 billion by 2030. Reblozyl is also in a Phase III trial for myelofibrosis patients with myeloproliferative neoplasm slated for a readout in 2025. However, competition may be heating up in the MDS market as Geron Corporation submitted its NDA earlier this month for a first-in-class telomerase inhibitor to treat transfusion-dependent anemia with lower risk MDS. Tested in a Phase III trial against a placebo, imetelstat showed significantly higher results in the eight-week transfusion independence endpoint. “The majority of patients with MDS experience chronic anemia and require RBC transfusions,” Tracey Iraca, executive director of the MDS Foundation, said in the BMS press release. “The approval of Reblozyl in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.” Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

New data emphasizes the value of MRD testing in predicting survival outcomes and informing the personalized treatment of patients with hematologic cancers clonoSEQ continues to be the MRD test of choice for biopharma companies as evidenced in over a dozen investigational studies across multiple therapeutic approaches SEATTLE, June 02, 2023 (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, will be included in several oral and poster presentations investigating the clinical significance of minimal residual disease (MRD) assessment at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago, as well as the European Hematology Association (EHA) Hybrid Congress taking place June 8-11 in Frankfurt, Germany. Data will be presented from clinical trials and real-world evidence studies using Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay for MRD assessment across a range of hematologic cancers. “The clinical trial and real-world evidence that is being presented this year at ASCO and EHA showcase clonoSEQ’s utility as the gold standard in MRD assessment both to inform clinical decision making and help assess deep responses to novel therapeutics in patients with hematologic cancers,” said Nitin Sood, chief commercial officer, MRD, at Adaptive Biotechnologies. “Adaptive has demonstrated the value of NGS-MRD assessment in hematologic cancers. The use of MRD assessment in clinical trials and practice continues to mount, and we are pleased to see new data generated that attest to its benefit for physicians, patients and researchers alike.” MRD can be used to assess depth of response and detect early signs of relapse prior to clinical symptoms. This assessment is performed as a series of tests in clinical trials and throughout a patient’s cancer journey. The clonoSEQ Assay is the first and only NGS-MRD test authorized by the U.S. Food and Drug Administration (FDA) for MRD assessment in certain hematologic malignancies. The assay is also offered as a CLIA-validated laboratory developed test for assessing MRD in diffuse large B-cell lymphoma (DLBCL). The clinical findings presented at both ASCO and EHA highlight the prognostic value and clinical actionability of precise, sensitive MRD assessment in hematologic cancers utilizing the clonoSEQ Assay. In various stages of multiple myeloma (MM), real-world evidence and clinical trial results reinforce the clinical significance of sustained MRD negativity and depth of response in the prediction of patient outcomes, including overall survival and progression free survival (PFS). In adults with acute lymphoid leukemia (ALL), real-world evidence found a higher rate of residual disease detection by clonoSEQ as compared to detection with flow cytometry. This data underscores the highly accurate, sensitive and standardized properties of clonoSEQ as compared to other technologies used to assess disease burden. Data continues to show the potential for MRD assessment to help in the personalization of cancer care. For example, interim data in older patients with DLBCL demonstrated that the use of MRD assessment from ctDNA with clonoSEQ in combination with imaging has potential to inform treatment decisions to shorten the duration of therapy. Final analysis from the multi-center Phase 2 MASTER trial showed that in newly diagnosed MM patients treated with quadruplet therapy and monitored using clonoSEQ, the three-year PFS was higher in patients with sustained MRD negativity compared to those who did not achieve MRD negativity. Furthermore, 73% of patients that discontinued therapy based on their MRD status remained free of therapy with sustained MRD negativity. The MASTER trial has been key for studying the feasibility of an MRD-informed approach to treatment discontinuation. The final outcomes reinforce that patients who achieve MRD negativity over time, as measured by clonoSEQ, may be able to discontinue treatment to find relief from treatment side effects and enable substantial savings for the health care system. Presentations will also highlight the value of utilizing NGS-MRD testing in clinical trials to assess the effectiveness of investigational, novel therapeutics. Key ASCO 2023 Presentations Presentation Type and Number Title Presentation Timing Multiple Myeloma Oral Abstract 8001 Maintenance therapy with carfilzomib, pomalidomide, and dexamethasone (KPd) in high-risk myeloma patients (pts): A phase 2 study with a safety run-in Saturday, June 3 1:15-4:15 p.m. CDT Poster Abstract 8028 Measurable residual disease (MRD) and clonal diversity for multiple myeloma treatment monitoring Monday, June 5 8:00-11:00 a.m. CDT Poster Abstract 8029 Long-term outcomes with isatuximab-carfilzomib-dexamethasone (Isa-Kd) in relapsed multiple myeloma patients with 1q21+ status: Updated results from the phase 3 IKEMA study Monday, June 5 8:00-11:00 a.m. CDT Poster Abstract 8031 Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM) Monday, June 5 8:00-11:00 a.m. CDT Poster Abstract TPS8066 MagnetisMM-7: An open-label, multicenter, randomized phase 3 study of elranatamab versus lenalidomide in post-transplant patients with newly diagnosed multiple myeloma Monday, June 5 8:00-11:00 a.m. CDT Poster Abstract 8009 CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma Monday, June 5 3:00-4:30 p.m. CDT Acute Lymphoblastic/Lymphoid Leukemia Oral Abstract 7007 A phase I trial of dose-adjusted EPOCH plus inotuzumab ozogamicin (InO) in adults with relapsed/refractory (R/R) B lymphoblastic leukemia/lymphoma (B-ALL) Friday, June 2 1:00-4:00 p.m. CDT Poster Abstract 7033 Comparison of next-generation sequencing and flow cytometry in detecting minimal residual disease in adult acute lymphoid leukemia: Evaluating clinical outcomes in a single-center study Monday, June 5 8:00-11:00 a.m. CDT Non-Hodgkin’s Lymphoma Poster Abstract 7554 Phase II trial of split-dose R-CHOP for older patients with diffuse large B-cell lymphoma (DLBCL) Monday, June 5 8:00-11:00 a.m. CDT Key EHA 2023 Presentations Presentation Type and Number Title Presentation Timing Multiple Myeloma Poster Abstract P931 Isatuximab in relapsed multiple myeloma patients with ultra-high-risk cytogenetics: ICARIA-MM and IKEMA subgroup analysis Friday, June 9 6:00 p.m.-7 p.m. CEST Poster Abstract P871 Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KARMMA-2 cohort 2C Friday, June 9 6:00 p.m.-7:00 p.m. CEST Oral Abstract S203 Quadruplet induction therapy, ASCT and MRD-modulated consolidation and treatment cessation in newly diagnosed multiple myeloma: final analysis of the MASTER trial Saturday, June 10 2:45 p.m.-4:15 p.m. CEST Chronic Lymphocytic Leukemia Poster Abstract P620 Genetic alterations and outcomes with fixed-duration ibrutinib+venetoclax (Ibr+Ven): results from the Phase 3 GLOW study in patients with previously untreated CLL Friday, June 9 6:00 p.m.-7:00 p.m. CEST About the clonoSEQ Assay The clonoSEQ Assay 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. Medicare covers clonoSEQ in these four indications and is aligned with clinical practice guidelines which support assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. The clonoSEQ Assay 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 therapy over time, monitor patients during remission, and predict potential relapse. 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 the clonoSEQ Assay in patients diagnosed with CLL, MM, ALL and DLBCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit About Adaptive Biotechnologies Adaptive 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 any statements regarding our 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 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 of 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 MEDIA Erica Jones, Associate Director, Corporate Communications 206-279-2423 media@adaptivebiotech.com ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations 201-396-1687 investors@adaptivebiotech.com