BioLineRx Ltd (BLRX)

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BioLineRx Announces Additional Positive Results from Pharmacoeconomic Study Comparing Motixafortide + G-CSF to Plerixafor + G-CSF in Stem Cell Mobilization

https://finance.yahoo.com/news/biolinerx-announces-additional-positive-results-120000822.html

- Results demonstrate highly significant cost benefits of using Motixafortide in combination with G-CSF, versus plerixafor with G-CSF, for stem cell mobilization in all multiple myeloma patients undergoing autologous stem cell transplantation

- Results reinforce and enhance the economic benefit seen in earlier evaluation of Motixafortide in combination with G-CSF, versus G-CSF alone, reported in Oct 2021

TEL AVIV, Israel, March 3, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced additional positive results from a follow-on pharmacoeconomic study that was performed based on data from the Company's successful Phase 3 GENESIS trial. This new study indirectly evaluated the cost-effectiveness of using the investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent in combination with granulocyte colony stimulating factor (G-CSF), against plerixafor in combination with G-CSF, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The results from the follow-on study, which was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, reinforce and enhance the economic benefits previously seen in the main study evaluating Motixafortide in combination with G-CSF, versus G-CSF alone, as part of the GENESIS study, on which the Company reported in October 2021.

The additional study results show that Motixafortide in combination with G-CSF, versus plerixafor in combination with G-CSF, demonstrates a statistically significant decrease in health resource utilization (HRU) during the ASCT process. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions, lifetime estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$30,000 (not including the cost of Motixafortide), versus plerixafor plus G-CSF. The study findings strengthen the assessment that the use of Motixafortide in combination with G-CSF, as the potential new standard of care in mobilization for ASCT, would be a cost-effective option in the US, based on accepted willingness-to-pay (WTP) values for healthcare payers.

"The results of this pharmacoeconomic study have now demonstrated significant net cost savings of using Motixafortide plus G-CSF, versus both plerixafor plus G-CSF and versus G-CSF alone," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These savings relative to available stem cell mobilization options, along with the vastly improved clinical outcomes demonstrated by our GENESIS Phase 3 study showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, further strengthen the commercial case for Motixafortide in combination with G-CSF in stem cell mobilization.

"This stronger performance and efficiency are particularly crucial when considering the trend toward more aggressive induction treatment protocols that leave patients needing more effective mobilization options. Accordingly, we believe our product has the potential to become the new standard of care for all multiple myeloma patients undergoing autologous stem cell transplantation, and potentially for other indications as well, addressing a market with estimated potential revenues of more than $360 million in the US alone. Our team is working diligently to bring this product to patients, and we now expect to file an NDA submission in mid-2022. If approved, Motixafortide would represent the first significant advancement in stem cell mobilization since the approval of plerixafor in 2008, and we intend to maximize the value of this opportunity for shareholders," Mr. Serlin concluded.

About the Follow-on Pharmacoeconomic Study

The follow-on study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, as a supplemental analysis to the original pharmacoeconomic study announced in October 2021 comparing motixafortide + G-CSF to G-CSF alone. For this follow-on study, an adjusted indirect comparison was undertaken, using data from the relevant phase 3 trials, to compare motixafortide + G-CSF with plerixafor + G-CSF, in stem cell mobilization in patients with multiple myeloma. This included finding and extracting efficacy data for both Motixafortide (from GENESIS patient-level data) and plerixafor (aggregate data from literature), estimating plerixafor efficacy as if it had been one arm of the GENESIS trial (Bucher method), and implementing the results in the cost-effectiveness model.

About the GENESIS Phase 3 Trial

The GENESIS Phase 3 trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. The study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized the target number of cells for transplantation with only one administration of Motixafortide and in only one apheresis session.

About Stem Cell Mobilization for Autologous Stem Cell Transplantation

Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma, non-Hodgkin's lymphoma and other lymphomas. In eligible patients, ASCT is performed after initial (induction) therapy, and, in most cases, requires consecutive-day clinic visits for the mobilization and apheresis (harvesting) phases, and full hospitalization for the conditioning chemotherapy and transplantation phases until engraftment. The associated burden is therefore significant – patients experience clinically relevant deteriorations in their quality of life during ASCT, and healthcare resource use throughout the ASCT phases is particularly intense. Therefore, new interventions impacting the ASCT process have the potential for relieving some of the clinical burden for transplanted patients, the logistical burden for the apheresis units, and the financial burden for healthcare providers and payers.

Described simply, ASCT consists of: (1) mobilizing the patient's own stem cells from his/ her bone marrow to the peripheral blood for removing (harvesting) via an apheresis procedure; (2) freezing and storing the harvested cells until they are needed for transplantation; (3) providing a conditioning treatment, such as high-dose chemotherapy or radiation, to kill the remaining cancer cells the day before transplant; and (4) infusing the stored stem cells back to the patient intravenously via a catheter.

To mobilize the patient's stem cells from the bone marrow to the peripheral blood for harvesting, the current standard of care includes the administration of 5-8 daily doses of granulocyte colony stimulating factor (G-CSF), with or without 1-4 doses of plerixafor, and the performance of 1-4 apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out, consisting of 1-4 additional doses of plerixafor on top of G-CSF, and the performance of an additional number of apheresis sessions as necessary. In light of this, an agent with superior mobilization activity may significantly reduce the mobilization and harvesting burden and associated risks of the ASCT process and lead to significant clinical and resource benefits.