Hanmi Pharmaceutical has terminated its global phase 2 clinical trial for poziotinib, a non-small cell lung cancer (NSCLC) treatment, for treating patients with epidermal growth factor receptor (EGFR) or HER2 exon 20 insertion mutation.

Hanmi Pharmaceutical has terminated its global phase 2 clinical trial into poziotinib due to difficulties in recruiting patients. (Hanmi)

According to Clinical Trials, a clinical information site operated by the U.S. National Institutes of Health (NIH), Hanmi Pharmaceutical recently changed the status of its global phase 2 clinical trial related to poziotinib from "recruiting" to "active but not recruiting." The firm also changed the study's completion date from April 2022 to August 2020, which means that the trial has officially ended.

The change is the first update to the clinical trial after the company started recruiting patients in August of last year.

The suspension of the trial comes after the company received approval from Korean and Chinese regulators to conduct phase 2 clinical trials in the two countries in April of last year.

The company had been planning to first recruit 40 patients at five local institutions -- National Cancer Center, Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Chungbuk National University Hospital. Afterward, the company planned to recruit 74 patients at 21 medical institutions in China, such as Beijing Cancer Hospital, Peking Union Medical College Hospital, and the First Hospital of Jilin University.

However, the company has only managed to recruit five patients in Korea a year after it announced such plans, which fell far short of its original goal of recruiting 114 patients.

"The company has ended the trial into poziotinib," a company official told Korea Biomedical Review. "The decision to terminate the trial was due to the hardship of recruiting patients as the Covid-19 outbreak hindered our ability to recruit patients for the trial."

However, the possibility of conducting a new trial still exists as the company still sees high potential for the substance.

"In the future, we will decide whether to proceed with a new clinical trial considering the various aspects of the situation," the official said. "The plan is to revise the protocol of some cohort studies and continue developing the compound."

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