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BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual Meeting

https://finance.yahoo.com/news/biolinerx-announces-poster-presentation-apheresis-110000617.html

TEL AVIV, Israel, April 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma. The poster will be presented at the American Society for Apheresis (ASFA) 2024 Annual Meeting, taking place April 17-19, 2024, in Las Vegas, Nevada.

Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3

The model in the poster at ASFA analyzed the number of apheresis days needed to collect ≥6 million CD34+ cells/kg using different mobilization regimens based on product-specific Phase 3 studies. A direct comparison was used between daily filgrastim alone and in combination with APHEXDA based on the Phase 3 GENESIS trial that supported the U.S. Food and Drug Administration (FDA) approval of APHEXDA. In the absence of head-to-head Phase 3 studies, an indirect comparison was made between daily filgrastim, plerixafor in combination with filgrastim, and APHEXDA in combination with filgrastim. The calculations were based on data from the MOZOBIL® (plerixafor) US Prescribing Information and local laboratory assessments in the GENESIS trial.4

"Variability in the time to mobilize sufficient stem cells for ASCT is a significant operational challenge for apheresis centers that can cause suboptimal experiences for patients, as well as delays in care and cost impact," said Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University. "Research of this type supports clinical and institutional decision making and we look forward to presenting the model at the poster session at ASFA."

Poster Presentation at the ASFA 2024 Annual Meeting
The Resorts World, Las Vegas, NV
Poster Session Details
Poster: Number P-28. See abstract in Journal of Clinical Apheresis.
Title: Enhancing Apheresis Center Efficiency with CXCR4 Antagonists: Evidence from the Phase 3 Trials
Authors: Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA
Date: April 17-19, 2024

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.

About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session. The study showed that APHEXDA combined with filgrastim (G-CSF) significantly enhanced the rate of mobilizing ≥6 × 106 CD34+ cells/kg in up to 2 apheresis days compared to placebo + filgrastim. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions.

About APHEXDA®
APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.6

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.

WARNINGS AND PRECAUTIONS

Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.

Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.

Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.

Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.

Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.

Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.

ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).

USE IN SPECIFIC POPULATIONS

Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.

Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.

Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.

Please see the accompanying full Prescribing Information.