Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 68

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 68
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 Cancer

Novel, emerging therapeutic approaches for targeting solid tumors
in oncology are being developed and tested. Combinational therapies of immune checkpoint inhibitors with immuno-oncology supporting agents,
with or without chemotherapy, are among the most promising experimental treatments for solid malignancies.

Pancreatic cancer has a low rate of early diagnosis, a high mortality
rate and a poor five-year survival prognosis. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed
until it reaches an advanced stage. Once the disease has metastasized, or spread to other organs, it becomes especially hard to treat.
In the United States in 2024, an estimated 67,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all
cancers in the U. S. and about 8% of all cancer deaths. Worldwide, an estimated 495,000 people were diagnosed with the disease in
2020. In the U. S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative
survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs,
the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year
relative survival rate is 3%. In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients
with metastatic pancreatic adenocarcinoma, or PDAC.

Furthermore, second-line patients that were diagnosed already with
metastatic disease have very few therapeutic options. The only approved regimen for second-line patients is Onivyde® in combination
with 5FU and LV. For these Stage IV at diagnosis patients reaching second-line therapy, median overall survival is only 4.7 months (Macarulla
et al, Pancreas 2020).

In January 2016, we entered into a clinical collaboration with
MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy. Based on this collaboration,
in September 2016 we initiated a Phase 2a study, known as the COMBAT/KEYNOTE-202 study, focusing on evaluating the mechanism of action
and safety of motixafortide in combination with KEYTRUDA®(