Global pharmaceutical company BeyondSpring announced positive findings in a late-stage trial of a drug combo to treat second- and third-line nonsmall cell lung cancer.
The stock soared nearly 150% on the data.
The company’s DUBLIN-3 trial-tested plinabulin in combination with docetaxel compared to docetaxel alone. Findings indicated the drug combo boosted overall survival, among other secondary endpoints. The randomized, single-blind study saw 559 participants enrolled, and patients in the treatment group received a 21-day cycle of docetaxel infusions and plinabulin versus docetaxel alone.
According to the American Cancer Society, up to 85% of lung cancers are nonsmall cell lung cancer, and smokers and nonsmokers are both at risk. A small portion of lung cancers may develop in people with no known risk factors. Those that occur in nonsmokers are typically different from those that occur in people who smoke, as they tend to be diagnosed in younger patients and have different genetic changes than tumors found in smokers.
"Plinabulin in combination with docetaxel (DP) showed statistically significant improvements compared to docetaxel alone," reads a company announcement issued Wednesday.
"The treatment of 2nd and 3rd line NSCLC, especially with EGFR wild type where tyrosine kinase inhibitors do not work, is an area of severe unmet medical needs," Dr. Trevor M. Feinstein of the Piedmont Cancer Institute and a principal investigator on the trial, wrote in a statement, later adding in part, "In DUBLIN-3, a prolonged survival benefit, characterized by a long-tailed OS curve, was observed with plinabulin that represents an immune associated anti-cancer benefit. The opportunity that plinabulin offers to these patients is not only to live longer, but also with significantly reduced severe neutropenia, which are both meaningful for these very sick patients."
Dr. Yan Sun, director of GCP Center at Cancer Hospital of Chinese Academy of Medical Sciences, noted it was "especially gratifying to see the doubling of 24- and 36-month OS rate with a favorable safety profile in the plinabulin combination arm."
BeyondSpring co-founder, CEO and chairwoman Dr. Lan Huang noted a pre-NDA meeting will be scheduled with the FDA in 2021 to back a nonsmall cell lung cancer indication NDA submission in the first half of 2022, marking the second indication and NDA for plinabulin. According to the FDA, "The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. "
FOX News' Alexandria Hein contributed to this report.