Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 69

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 69
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pembrolizumab),
MSD’s anti-PD-1 therapy, in 37 patients with metastatic PDAC. The study was an open-label, multicenter, single-arm trial designed
to evaluate the mechanism of action, safety and tolerability, and clinical response of the combination of these therapies. The mechanistic
evaluation consisted of multiple pharmacodynamic parameters, including the ability to improve infiltration of T-cells into the tumor and
their reactivity. Top-line results showed that the dual combination demonstrated encouraging disease control and overall survival in patients
with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported motixafortide’s ability to induce infiltration
of tumor-reactive T-cells into the tumor, while reducing the number of immune regulatory cells.

38

In July 2018, we announced the expansion of the COMBAT/KEYNOTE-202
study under the collaboration to include a triple combination arm investigating the safety, tolerability and efficacy of motixafortide,
KEYTRUDA®and chemotherapy. We initiated this
arm of the trial in December 2018. In December 2019, we announced that preliminary data from the study indicated that the triple combination
therapy showed a high level of disease control, including seven partial responders and 10 patients with stable disease out of 22 evaluable
patients. In February 2020, we completed the recruiting of a total of 43 patients for the study and in December 2020, we announced the
final results of the study. The results of the study showed substantial improvement as compared to comparable historical results of other
pancreatic cancer studies across all study endpoints. Of the 38 evaluable patients, median overall survival was 6.5 months, median progression
free survival was 4.0 months, confirmed overall response rate was 13.2%, overall response rate was 21.2% and disease control rate was
63.2%. The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component
alone; adverse event and severe adverse event profiles were as expected with chemotherapy-based treatment regimens.

In October 2020, we announced that motixafortide will be tested
in combination with the anti-PD-1 cemiplimab (LIBTAYO®)
and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line PDAC. This investigator-initiated Phase 2, single-arm
study