Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 64

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 64
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 increase. The combination was also found to be generally well tolerated with a favorable
safety profile. In GENESIS, safety was evaluated in 92 patients with multiple myeloma who received motixafortide 1.25 mg/kg subcutaneously
plus G-CSF, and 42 patients who received placebo plus G-CSF. Serious adverse reactions occurred in 5.4% of patients receiving motixafortide
plus G-CSF. These reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia
and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema
and pruritus), pruritus, flushing, and back pain. We continue to follow-up on the GENESIS study patients for relapse-free and overall
survival, according to the statistical analysis plan agreed upon with the FDA.

36

In October 2021, we announced positive results from a pharmacoeconomic
study evaluating the cost-effectiveness of using motixafortide as a primary stem cell mobilization agent on top of G-CSF, versus G-CSF
alone, in multiple myeloma patients undergoing autologous stem-cell transplantation (ASCT). The study was performed by the Global Health
Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial.
The study concluded that the addition of motixafortide to G-CSF (the current standard of care) was associated with a statistically significant
decrease in health resource utilization (HRU) during the ASCT process, compared to G-CSF alone. Based on the significantly higher number
of mobilized cells and the lower number of apheresis sessions, lifetime estimates showed quality-adjusted-life-year (QALY) benefits and
net cost savings of approximately $19,000 (not including the cost of motixafortide), versus G-CSF alone.

In March 2022, we announced results from a follow-on pharmacoeconomic
study performed by the HEOR team of IQVIA. This study indirectly evaluated the cost-effectiveness of using motixafortide as a primary
stem cell mobilization agent in combination with G-CSF, against plerixafor in combination with G-CSF, in multiple myeloma patients undergoing
ASCT. The additional study results showed that mot