"Seventy-seven percent of patients were able to achieve disease control rate," said Philip Serlin, chief executive officer of BioLineRx.
By MAAYAN JAFFE-HOFFMAN ,
THE JERUSALEM POST, DECEMBER 16, 2019
https://www.jpost.com/HEALTH-SCIENCE/New-Israeli-pancreatic-cancer-treatment-could-extend-most-patients-lives-611085
More than three-fourths (77%) of patients suffering from stage IV metastatic pancreatic adenocarcinoma (pancreatic cancer) and treated with a protocol developed by an Israel-based biopharmaceutical company were able to get their disease under control, according to results of an ongoing study.
Modi’in-based BioLineRx revealed updated data from the triple combination arm of its ongoing Phase 2a COMBAT/KEYNOTE-202 study – which shows double the positive effect on the treatment of pancreatic cancer compared to the approved second-line chemotherapy treatment for the disease – at a conference in Geneva last week.
Almost a third (32%) of patients from the study who could be evaluated saw a reduction in tumor size (of more than 30% from baseline), as opposed to 17% of patients treated with chemotherapy, based on historical data. Furthermore, another 45% of patients were able to stabilize the disease, meaning that tumor size neither grew nor was reduced by much over the course of the trial.
“That means 77% of patients were able to achieve disease control rate,” said Philip Serlin, CEO of BioLineRx. This is compared to 52% of patients who are treated with chemotherapy alone. “Although it cannot be automatically assumed, one could surmise that if there is a higher response rate, there will be a longer progression-free survival,” he said.
“Our hope is that therefore, patients will live longer.” He noted that while the primary endpoint of this study is the objective response rate, secondary endpoints include overall survival, progression-free survival and disease control rate.
The median overall survival will only be able to be determined by mid-2020. However, Serlin added that some patients have already survived with the treatment for more than 330 days – almost a year – which is a substantial increase for those diagnosed with stage IV metastatic pancreatic cancer who have failed first-line treatment.
“Pancreatic cancer is a terrible disease,” Serlin told The Jerusalem Post. “The prognosis with metastatic cancer is only a 3% survival rate over a five-year period. Most patients die within a few months to half a year. It is a very difficult disease.”
Serlin explained that there have not been many advances in pancreatic cancer treatment over the past decade, and that it is the only cancer among the top five cancers where the number of patients that are dying each year is rising.
For most other cancers – even if the number of diagnoses is on the rise – deaths are going down due to better treatments. There are two reasons for this, he said. One is that most people are diagnosed with pancreatic cancer in the late stage: “It is considered a silent killer, as it is often not detected until it is in stage IV,” he said.
Moreover, he said that pancreatic cancer has developed mechanisms that enable it to protect itself from the body’s immune system. “It builds sort of an immunosuppressive environment that surrounds it – a shell so to speak – that does not allow the body’s immune system to attack the cancer the way it can attack some other cancers,”
Serlin explained. “Immunotherapies have become the holy grail of cancer treatment, but they don’t work on pancreatic cancer.” MERCK’S KEYTRUDA is one example. Keytruda is one of the industry’s best-selling and most successful immunotherapy drugs, but it is not able to pierce the defense system that surrounds pancreatic cancer cells.
Merck, like its competitors, was looking for immunotherapy combinations that will improve outcomes for pancreatic cancer patients. Recent results indicate that BioLineRx’s BL-8040 – administered in combination with chemotherapy and Keytruda – might be that combination. In this triple combination arm protocol, patients receive BL-8040 monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), Keytruda and BL-8040 until progression.
“It is a complex regime,” he admitted. “But these are extremely sick patients so they are more than willing to come and get treatment if they don’t have any other options.” BL-8040 is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic cancer, a release explained. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis. BL-8040 is a platform molecule, Serlin explained.
It can be combined with many different agents potentially to work in various areas of the cancer space. Already, BL-8040 is being tested in human clinical trials to successfully treat acute myeloid leukemia and stem cell mobilization for bone marrow transplantation in multiple myeloma.
The study, whose data was revealed last week for the first time at the European Society of Medical Oncology Immuno-Oncology Congress in Geneva, was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies. It was carried out in the US, Israel and Spain.
The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 with Merck. BioLineRx is developing a second oncology program: AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being tested in Phase 1 and 2a studies. Serlin described the BioLineRx and Merck combination as having an “extremely encouraging effect.”
“The results are even stronger when taking into account the extended durability of clinical benefit seen to date in this study (median of 7.8 months), compared to approximately three months of response duration with other treatments for second-line pancreatic cancer,” said Dr. Manuel Hidalgo, chief of the Division of Hematology and Medical Oncology and a senior member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study.
“I look forward to the survival data expected in mid-2020.” Serlin added that “these data continue to confirm our hypothesis relating to the synergistic effect of cytotoxic chemotherapy, along with the trafficking, tumor microenvironment modulation and T-cell infiltration effects seen in pancreatic cancer patients from previous dual combination trials of BL-8040 with checkpoint inhibitors.
“It is therefore very encouraging to see robust and durable responses to the triple combination treatment, especially as we continue to see a trend of patients receiving treatment for an extended period that move from stable disease to partial response,” he continued. “We hope to see these results translate into an extended survival benefit for these patients.”
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