Samsung Pharmaceutical said Monday that it has confirmed the efficacy and safety profile of Riavax, a pancreatic cancer drug, in phase 3 clinical trials.

Samsung Pharm conducted the study for five years, from November 2015 to April 2020, on 148 patients with locally advanced and metastatic pancreatic cancer at 16 hospitals, including the Severance Hospital. The company administered Riavax combined with existing anticancer drugs, gemcitabine and capecitabine.

Riavax injection is based on GV1001, a peptide composition developed by GemVax and Kael for treating pancreatic cancer.

The study revealed that GV1001 is safe for patients with pancreatic cancer and showed a statistically significant difference in the median overall survival (MOS) and the time to progression (TTP). Researchers analyzed the study results using the “copula method” and observed 339 days of MOS in the experimental group and 225.5 days in the control group.

No special side effects were confirmed in the study. There was no statistically significant difference in the incidence of adverse reactions between the control and experimental group, the company said.

“According to the 2017 cancer registration statistics published by the National Cancer Center, the five-year survival rate of patients with pancreatic cancer is rising. When metastasis progresses, however, the survival rate is only about 2 percent,” a company official said.

Considering that even Gemcitabine-based primary chemotherapy provides an average survival time shorter than 12 months, 2 to 3.7 extended months seem to be significant for those with pancreatic cancer, he added.