Korean biopharmaceutical companies drew attention by unveiling clinical trial results of anticancer drug candidates at ASCO Gastrointestinal Cancers Symposium (ASCO GI) being held in San Francisco, Calif., Jan. 18 to 20.
The anticancer drug candidates developed by Idience, AbClon, Genome & Company, and HLB showed therapeutic effects in gastric and liver cancers, raising the possibility of commercialization.
Idience, the drug-developing arm of Ildong Pharmaceutical, released the interim results of a phase 1 clinical trial in which patients with gastric cancer were treated with a combination of venadaparib, a targeted therapy anticancer drug candidate, and irinotecan, a chemotherapy anticancer drug.
Venadafarib is a targeted therapeutic anticancer drug candidate with a poly ADP-ribose polymerase (PARP) inhibition mechanism of action. The results were obtained in patients with HER2 (human epidermal growth factor receptor 2) positive and negative gastric cancer.
According to Idience, the exploratory dose combination of venadafarib and irinotecan demonstrated an objective response rate (ORR) of 36.4 percent and a median progression-free survival (mPFS) of 5.6 months in the evaluable patient population (11 patients).
Idience pursues clinical development of venadaparib in gastric, breast, ovarian and papillomavirus resistant cancers, intending to enter approval trials (phase 2/3) next year.
AbClon's AC101 showed promise as a first-line treatment in a second-line clinical trial in HER2-positive gastric cancer patients. Shanghai Henlius Biotech announced interim results from the ongoing phase 2 study of AC101 in 53 patients with HER2-positive gastric cancer at ASCO GI. AC101 is an antibody therapy for HER2-positive gastric cancer developed by AbClon and licensed to Henlius in 2018.
Interim results from the phase 2 trial of AC101 demonstrated a greater therapeutic benefit with the addition of AC101 than with the combination of HLX02 (trastuzumab), a Herceptin biosimilar, and XELOX in HER2-positive locally advanced or metastatic patients.
The trial was divided into three groups -- a low-dose combination of AC101 (15 mg/kg), a high-dose combination of AC101 (25 mg/kg), and a control group.
According to AbClon, the objective response rate (ORR) measured 48 weeks post-dose was 58.8 percent in the low-dose arm, 38.9 percent in the high-dose arm, and 16.7 percent in the comparator arm. Median progression-free survival (PFS) was 8.2 months in the comparator arm and 15.1 months in the high-dose arm. The median has not yet been reached in the low-dose arm.
Genome & Company presented phase 2 cutoff data for GEN-001, a microbiome immuno-oncology therapy in gastric cancer. It is an oral treatment based on a single strain of Lactococcus lactis, studied in combination with Merck's Bavencio (avelumab) in a phase 2 gastric cancer trial.
The trial is being conducted at six sites in Korea, enrolling 42 patients with PD-L1-positive advanced gastric or gastroesophageal junction adenocarcinoma who have failed two or more lines of standard therapy, regardless of prior immuno-oncology therapy.
According to Genome & Company, the efficacy evaluation of the 42 patients in the phase 2 trial demonstrated seven Partial Responses (PRs), including three out of eight patients (objective response rate, 37.5 percent) who had received and failed prior immuno-oncology therapy. Median progression-free survival (mPFS) was 1.7 months and median overall survival (mOS) was 7.9 months.
HLB demonstrated the efficacy of rivoceranib in liver cancer at the symposium. HLB presented results from a phase 3 trial of its liver cancer drug rivoceranib in combination with China's Jiangsu Hengrui Pharmaceutical's immuno-oncology drug camrelizumab in patients with liver cancer.
The trial directly compared the efficacy and safety of the rivoceranib-camrelizumab combination with Bayer's Nexavar (sorafenib), an existing first-line standard of care for liver cancer.
According to HLB, median overall survival (mOS) in patients with some decline in liver function (ALBI grade 1) was 23.9 months with the rivoceranib combination, compared to 15.4 months with sorafenib. Even in patients with relatively severe liver function decline (ALBI grade 2), the difference was 19.1 months vs. 12.3 months, demonstrating treatment efficacy in all patient groups.
"It’s not that Korean companies are intensively developing drugs for digestive cancers,” an industry executive said. “Still, they are actively developing anticancer drugs because the unmet demand is expected to continue. As the category of digestive cancer is broad, the market size is not small."