On Friday, BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) reported results of a combined trial of its lead product BL8040 and Keytruda (pembrolizumab), marketed by Merck & Co., Inc. (MDS) for treatment of pancreatic cancer. The company described the results as "encouraging", particularly in patients undergoing second treatment after ineffective previous treatment. The market was clearly disappointed with the results, however; shares in BiolineRX fell 21% on Nasdaq on Friday, making it a 41% drop in two days. The share price is currently down 29.4% on the Tel Aviv Stock Exchange.
The trial was a IIa trial, that is an initial efficacy trial. It included 37 patients who received the drug after ceasing to respond to previous treatment. Initially, Bioline's drug was administered as the sole treatment for five days, and then it was administered together with Keytruda for three weeks.
The results show that the disease did not progress for 72 days in ten patients, of whom one actually showed improvement. The average survival period of all the trial patients was 3.3 months, and one third reached 6 months. Among those receiving the drug as a second treatment, the average survival period was 7.5 months. The company says that this compares favorably with the average survival period of patients receiving second treatment in the form of chemotherapy.
The results do not look like a breakthrough as far as efficacy is concerned, but could indicate an alternative to chemotherapy if hospitals conclude that the side-effects of Bioline's drug are less severe. At present, there is almost no treatment for pancreatic cancer, and so a brief extension of life can be considered a success and may lead to registration of the product for marketing. The next stage is to test a combination of the two drugs with chemotherapy.
BiolineRX CEO Philip Serlin said, "We are extremely pleased with the top-line results from this ongoing study. These data, which demonstrate that the combination of BL-8040 and Keytruda is safe, with encouraging signs of clinical activity and proof of concept for the mechanism of action, support the combination’s potential to become an effective immunotherapy regimen for pancreatic cancer - a disease that has responded very poorly to available treatments, including immunotherapy. We look forward to expanding our collaboration with MSD and maximizing the potential of this combination through an additional study arm that will add chemotherapy to the regimen. We look forward to commencing the triple combination arm of this important study by the end of this year, with results expected in the second half of 2019."
BiolineRX's share price rose sharply recently when the company announced that it had raised its holding in its leading product, which was perceived by the market as a vote of confidence in the product. The share price is now 13% below the level it was at before that rise.
Published by Globes, Israel business news - en.globes.co.il - on October 21, 2018
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