Samsung Pharmaceutical Announces Phase 3 Clinical Trial Results of Pancreatic Cancer Treatment Liabax

[Asia Economy Reporter Hyunseok Yoo] Samsung Pharm announced on the 28th that it has received the Phase 3 Clinical Study Report (CSR) for the pancreatic cancer treatment drug ‘Liabex Injection’.

Since November 2015 until April of this year, Samsung Pharm conducted a Phase 3 clinical trial over approximately five years at 16 hospitals nationwide, including Yonsei University Severance Hospital, involving a total of 148 patients with locally advanced and metastatic pancreatic cancer. The trial aimed to demonstrate the safety and efficacy of combining Liabex Injection with existing pancreatic cancer chemotherapy drugs Gemcitabine and Capecitabine. Liabex Injection is a product developed as a pancreatic cancer treatment using the peptide composition 'GV1001' developed by GemVax & KAEL.

According to the report, GV1001 is a drug that can be safely administered to pancreatic cancer patients, and the combination of Gemcitabine/Capecitabine with GV1001 (Gemcitabine/capecitabine+GV1001) showed statistically significant differences in median OS (overall survival) and TTP (time to tumor progression) compared to Gemcitabine/Capecitabine alone (p=0.021).

The detailed results of the efficacy and safety analysis are as follows. For efficacy analysis, the Copula method (joint probability distribution between uniform distributions) was applied. The median overall survival, the primary endpoint, was 339 days in the treatment group and 225.5 days in the control group, with the treatment group showing a longer duration. The difference in median overall survival between the two groups was statistically significant (p=0.021).

Another important endpoint, the median time to tumor progression, was 220 days in the treatment group and 136 days in the control group, with the treatment group again showing a longer duration. The difference between the two groups was statistically significant (p=0.021). Regarding CA19-9 changes over time, which are important for pancreatic cancer progression and prognosis prediction, a statistically significant difference was observed at the 5-week mark in the treatment group compared to the control group (p=0.0313). The mean change in CA19-9 in the treatment group was lower than that in the control group at all time points except at 54 weeks. Other evaluation variables such as response rate and quality of life did not show statistically significant differences between the groups.

In the safety analysis, no significant adverse effects were observed. There were no statistically significant differences between the control and treatment groups in the incidence rates of treatment-emergent adverse events (TEAE), adverse drug reactions (ADR), serious adverse events (SAE), adverse reactions leading to discontinuation of the investigational drug, or adverse reactions leading to death. Additionally, no notable differences were reported between the groups regarding clinical laboratory tests, vital signs, body weight, or physical examinations.

A Samsung Pharm official stated, “According to the 2017 cancer registry statistics published by the National Cancer Center, although the 5-year survival rate for pancreatic cancer is on the rise, it remains around 10%, and drops to about 2% when distant metastasis occurs, which is very low. Considering that the average survival period does not exceed 12 months even with Gemcitabine-based first-line chemotherapy, an extension of survival by approximately 2 to 3.7 months is considered meaningful for pancreatic cancer patients.” He added, “The detailed clinical trial results will be published in a paper, and as originally planned, preparations will be made for formal approval application based on the clinical trial results obtained this time.”

This content was produced with the assistance of AI translation services.