Aslan Pharmaceuticals announced an update on its global placebo-controlled, double-blind phase 2 clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6. In the recently completed study, varlitinib did not meet the primary endpoint of significant reductions in tumor size after 12 weeks of treatment. Based on independent central review, patients treated with varlitinib plus mFOLFOX6 had an average tumour shrinkage of 22.0% after 12 weeks compared to 12.5% for patients treated with mFOLFOX6 alone. This difference did not reach statistical significance. Upon review of 17 progression free survival events to date, there was a trend toward an improvement in PFS in patients treated with varlitinib. Overall patient characteristics were well-balanced between the two arms with the exception of baseline ECOG status. The proportion of patients with the best performance status was substantially higher in the control arm than in the varlitinib arm.Varlitinib in combination with mFOLFOX6 was very well-tolerated with 73.1% of patients taking varlitinib experiencing a grade 3 or higher adverse event compared to 88.5% of patients taking mFOLFOX6 alone. Aslan will continue to analyze data from this study, working with study investigators on the future publication of these results, and will focus on development in biliary tract cancer and other indications where varlitinib has shown activity.
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