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Ar. The dual ex (NYSE: BLRX) is now plunging about 30% in New York trading after the biopharmaceutical company focusing on oncology reported today results from the triple therapy arm in the Phase 2a clinical trial, COMBAT-KEYNOTE-202, for motixafortide evaluation in combination with KEYTRABLE for combination and Stage 4 metastasis in line two treatment. The company tried to present the results as positive, and reported that improvement was achieved in all experimental targets, including overall survival rate, disease-free survival rate and overall response rate, in the most severe patients with metastatic pancreatic cancer considered one of the most violent cancers. However, the said market was less enthusiastic about the results.
In the background, it should be noted that the Bioline share has jumped sharply over the last 3 trading days – a jump of about 47%, without reporting any significant event in connection with the company, which may indicate large market views ahead of the results, which actually disappointed. .
Bioline shares in the last six months – a sharp jump from December 9
According to the report, the triple treatment arm of the trial included 43 patients who were diagnosed with stage 4 metastatic pancreatic cancer and whose disease progressed after first-line treatment with gemcitabine. Patients were treated for 5 days with motixafortide as a single treatment and then with cycles of motixafortide combination therapy, KEYTRUDA. The main objective of the experiment is the objective response rate (ORR); Secondary goals include Approved Objective Response Rate (cORR), Overall Survival (OS), Disease Progression (PFS), and Disease Control Rate (DCR).
The results of the experiment showed a significant improvement across all the objectives of the experiment compared to historical data. The results summarized below are for 38 patients who are eligible for evaluation:
summary of results
Source: Bioline RX
The combination of drugs is found to be generally usable, with a safety profile that matches that of each of the components of the combination separately; The side effect profile (AE), as well as severe side effects (SAE), is consistent with what is expected from chemotherapy-based treatments. Safety benefits can be seen in the combination of motixafortide, KEYTRUDA and chemotherapy compared to historical data of the specific chemotherapy used in the trial. These safety benefits include an incidence of grade 3 neutropenia (7% vs. 20% in the historical data) and an incidence of grade 3 infections (7% vs. 17% in the historical data).
So why is the stock going down?
The main reason for the disappointment of investors and the collapse of the stock is probably due to the ORR rate, which stood at about 21.2% compared to 16% in history. Apparently these are good results, but what the company did not present in the table above was the ORR data reported in the interim results of the experiment about a year ago, which stood at about 32% and now dropped sharply to 21.2%.
Still … seemingly these are good results in relation to history. And so will the company claim (see the company’s management statement below), but it’s not really clear why the company chose to present the specific “history” data it presented, which in the specific case of the ORR speaks only of chemotherapy.
And even if we assume that the combination that the company offers as a treatment, which uses a combination of Bioline’s motixafortide, with chemotherapy and with KEYTRUDA which is a very expensive drug in itself, and all this “seemingly” to extend the life expectancy of patients by about two months … Earn significantly, even assuming treatment is eventually approved.
Professor Manuel Hidalgo, Head of the Division of Hematology and Medical Oncology at Weill Cornell and Chief Researcher in the Experiment: “These results are very encouraging, in light of the very challenging population, even among the pancreatic cancer patients, who were included in this trial. All patients were first diagnosed with stage 4 metastatic pancreatic cancer and over 70% had liver metastases, facts that are a major factor in poor prognosis. Believes that these results from the experiment clearly justify further development.
Philip Serlin, CEO of Bioline RX: “We are very pleased with these results, which show a significant improvement over historical data in all experimental objectives. Consistent improvement throughout the experimental objectives is a key difference compared to other molecules which in early experiments showed improvement in only one experimental target, and ultimately failed in advanced experiments. Are also supported by a prolonged median clinical effect of 5.6 months that was observed in the trial. ”
“Pancreatic cancer is one of the most difficult cancers to treat, with a five-year survival rate for all patients of only 9%, and for over 50% of patients first diagnosed with stage 4 disease, the five-year survival rate is even lower at 3%. Marginal improvements in survival targets in pre-registration trials are considered clinically significant and sufficient for regulatory approval. This indication. ”
In addition, we believe that these results significantly support the further development of the combination of motixafortide with an inhibitor of immune control protein and chemotherapy currently accepted on the market, for earlier treatment lines for metastatic pancreatic cancer, and for other “cold” solid tumors. “We are examining the combination of motixafortide with anti-PD-1 and chemotherapy (gemcitabine and nab-paclitaxel) in patients with first-line pancreatic cancer, and we are also examining additional combinations in other cancerous tumors.”
“These results are particularly exciting in light of the positive interim results from motixafortide’s Phase 3 clinical trial, GENESIS, for stem cell mobility, which we reported in October. Motixafortide has demonstrated clinical efficacy in two therapeutic areas in a variety of mechanisms of action, supporting our belief that it can be used. For the treatment of a wide variety of cancers, “Serlin concluded.