Hutchison China MediTech Limited has announced the initiation of a Phase II expansion of the ongoing TATTON trial (NCT02143466) to evaluate the selective c-Met inhibitor savolitinib (AZD6094) 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, a disease that is estimated to afflict approximately 1.7 million new patients annually worldwide.
The trial is a single-arm global Phase II study of savolitinib in combination with Tagrisso (osimertinib/AZD9291) in advanced NSCLC patients who have developed resistance to approved EGFR tyrosine kinase inhibitors (“TKIs”). This expansion was initiated following encouraging early data from a number of patients enrolled in the TATTON study who received savolitinib in combination with Tagrisso.
The initiation of the expanded Phase II study has triggered a US$10 million milestone payment to Hutchison MediPharma Limited (“HMP”) (a 99.8% held subsidiary of Chi-Med) under the terms of the agreement with AstraZeneca PLC (“AstraZeneca”) signed in December 2011. HMP and AstraZeneca are conducting Phase II studies in NSCLC with savolitinib in monotherapy, as well as in combination with either Tagrisso or Iressa (gefitinib). AstraZeneca continues to lead and invest in the global NSCLC development program for savolitinib.
Susan Galbraith, Senior Vice President, Head of Oncology Innovative Medicines, AstraZeneca, said: “Savolitinib is a highly selective c-Met inhibitor that is being investigated in a number of cancers including in patients with lung cancer whose disease is driven by aberrant c-Met / HGF signaling. We are extremely excited by the data we have seen for savolitinib when used in combination with our EGFR tyrosine kinase inhibitors. We are committed to advancing research to develop a broad range of potential treatment options for patients with lung cancer.”
Christian Hogg, Chief Executive Officer of Chi-Med, said: “We estimate that the annual incidence of patients with MET-driven NSCLC in the U.S., European Union and Japan totals about 40,000-50,000 in all treatment settings. This is an important unmet medical need and one that we believe savolitinib is well suited to address because of its very high selectivity. 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.”
NSCLC DEVELOPMENT PROGRAM HIGHLIGHTS
Savolitinib continues to be explored in a range of MET-driven NSCLC settings including:
• Savolitinib in combination with Tagrisso or Iressa in Phase II expansions of ongoing studies in advanced EGFR mutant NSCLC
• Savolitinib + Tagrisso combination Phase II study in third-line NSCLC (for patients progressing on T790M-directed therapies)
• Savolitinib monotherapy Phase II study in NSCLC
Savolitinib is in clinical development in multiple MET-driven solid tumor indications including NSCLC, kidney, gastric and colorectal cancer.