Hutchison Chi-Med upbeat on latest Iressa trial results

Hutchison China MediTech - commonly known as Chi-Med - reported preliminary clinical activity, safety, and tolerability data of fruquintinib, an investigational selective inhibitor of vascular endothelial growth factor receptor given in combination with Iressa, on Monday.

The AIM and Nasdaq-traded firm said the data came from an ongoing Phase II proof-of-concept trial conducted in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer.

It said preliminary data from the Phase II proof-of-concept trial - the first study assessing combining fruquintinib with another tyrosine kinase inhibitor - demonstrated promising efficacy and an acceptable safety profile.

The data was presented at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Yokohama, Japan, on 15-18 October.

“Having proven efficacy as a monotherapy in colorectal cancer, fruquintinib is now demonstrating its tolerability and efficacy in innovative combinations which are made possible because of its high kinase selectivity, negligible off-target toxicity, and clean drug-drug interaction profile,” said Chi-Med’ chief executive Christian Hogg.

“In January 2017, preliminary tolerability and efficacy of fruquintinib in combination with chemotherapy, Taxol (paclitaxel), was reported in a Phase I/II trial in gastric cancer.

“Now, this early Iressa combination data further validates our long-held research approach to create highly selective and optimized drug candidates.”

The study assessed fruquintinib - 4 to 5mg, once daily three weeks on / one week off - in combination with Iressa - 250mg, once daily - in China as a first-line treatment for patients with EGFRm advanced NSCLC.

Chi-Med said the most common treatment-emergent adverse events in 26 patients were increased aspartate aminotransferase, increased alanine aminotransferase, increased total bilirubin, increased thyroid stimulating hormone, and rash.

The eight grade 3 adverse effects were increased alanine aminotransferase, increased aspartate aminotransferase, proteinuria, and hypertension.

There were no serious adverse effects, or those that lead to death.

Preliminary results in 17 efficacy evaluable patients showed an overall response rate of 76% and a disease control rate of 100%.

Four partial responses were not yet confirmed at the time of data cut-off.