Aslan Pharmaceuticals Ltd. said its gastric cancer drug varlitinib did not meet the main goal of statistically significant tumor reductions in a mid-stage study.
The 12-week phase 2 trial evaluated varlitinib as a first-line therapy, in combination with chemotherapy regimen mFOLFOX6, against placebo plus mFOLFOX6.
The study enrolled previously untreated patients with advanced or metastatic gastric cancer that expresses human epidermal growth factor receptor 1 and 2 — key proteins in cancer progression.
Aslan Pharmaceuticals said the varlitinib-mFOLFOX6 combination delivered average tumor shrinkage of 22%, which is not statistically significant compared to 12.5% average tumor shrinkage produced by mFOLFOX6 alone.
Of 17 progression-free survival events, which refers to patients living without their cancer worsening, there was a trend toward longer progression-free survival in patients who received varlitinib.
Meanwhile, overall patient characteristics were well-balanced between the two treatment arms, except for the baseline status set by U.S. cancer research organization Eastern Cooperative Oncology Group, or ECOG. Aslan Pharmaceuticals said 46.2% of patients who received mFOLFOX6 alone had the best ECOG performance status of 0, meaning they can function as well as they did pre-disease. Only 19.2% of patients who received varlitinib had an ECOG performance status of 0.
Aslan Pharmaceuticals said varlitinib was very well-tolerated in the trial, with 73.1% of patients experiencing a grade 3 or higher adverse event, compared to 88.5% of patients taking mFOLFOX6 alone.
Varlitinib is being studied in gastric, biliary tract, breast and colorectal cancers. The U.S. Food and Drug Administration has granted the drug orphan-drug status for gastric cancer and cholangiocarcinoma. Singapore-based Aslan Pharmaceuticals acquired full global rights to varlitinib from Array BioPharma Inc. in January 2018.
Aslan will continue to analyze the study results, and will focus on developing the drug for indications where it has shown activity.