Chi-Med expands TATTON Phase II trial

Healthcare group Hutchison China MediTech (Chi-Med) announced on Monday the start of a Phase II expansion of its ongoing TATTON trial.

The AIM-traded firm said the TATTON trial is evaluating the selective c-Met inhibitor savolitinib in epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) patients.

Savolitinib has the potential to address major unmet medical needs in c-Met-driven subsets of NSCLC, the company said; a disease that is estimated to affect around 1.7 million new patients annually worldwide.

The trial is a single-arm global Phase II study of savolitinib in combination with ‘Tagrisso’ (osimertinib) in advanced NSCLC patients who have developed resistance to approved EGFR tyrosine kinase inhibitors.

Chi-Med said the expansion was initiated after encourage early data from a number of patients enrolled in the TATTON study, who received savolitinib in combination with ‘Tagrisso’.

The initiation of the expanded study has triggered a $10m milestone payment to Hutchison MediPharma - a 99.8%-held subsidiary of Chi-Med - under the terms of an agreement with AstraZeneca signed in 2011.

“We estimate that the annual incidence of patients with MET-driven NSCLC in the US, European Union and Japan totals about 40,000-50,000 in all treatment settings,” said Chi-Med chief executive Christian Hogg.

“This is an important unmet medical need and one that we believe savolitinib is well suited to address because of its very high selectivity.”

Hogg said this allows for effective target coverage of c-Met, as well as safe and tolerable combinations with other oncology agents.

“We believe that savolitinib either as a monotherapy in first-line NSCLC, or in proprietary combinations with AstraZeneca's ‘Iressa’ and ‘Tagrisso’ in second- and third-line NSCLC, will address the key genetic drivers of cancer cell proliferation in these very difficult-to-treat NSCLC patients.

“We are hopeful about proceeding into Phase III in 2017 based on future data from this study,” Hogg added.