AstraZeneca and Hutchmed have commenced the Phase III SACHI clinical trial of Orpathys (savolitinib), plus Tagrisso (osimertinib) in locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) patients in China.
The first subject in the trial was administered the first dose, Hutchmed noted.
Savolitinib is an oral and selective MET tyrosine kinase inhibitor (TKI), marketed as Orpathys in China.
It works by hindering the MET receptor tyrosine kinase pathway activation that is caused by gene amplification or mutations.
The companies had signed an international licensing agreement in 2011 to co-develop and co-market savolitinib.
Hutchmed is carrying out the development activities in China while AstraZeneca oversees the development outside of the country.
An irreversible epidermal growth factor receptor (EGFR) TKI, AstraZeneca’s Tagrisso is claimed to offer clinical activity against central nervous system metastases.
The open-label, multicentre, randomised, controlled trial will assess the efficacy and safety of Orpathys plus Tagrisso versus platinum-based doublet-chemotherapy in patients who have developed MET amplification after disease progression on EGFR inhibitor treatment.
Median progression-free survival (PFS) as measured by trial investigators will be the primary goal.
Median PFS evaluated by an independent review committee, objective response rate, median overall survival, duration of response, time to response, disease control rate and safety will be included as other goals.
The SACHI study builds on positive data from the Phase Ib/II TATTON trial of the combination therapy in more than 220 individuals with EGFR inhibitor refractory NSCLC whose tumours harbour aberrations of MET.
Data showed that Orpathys plus Tagrisso had good anti-tumour activity, as well as a favourable risk-benefit profile.
Earlier this month, the companies started a Phase III SAMETA trial of savolitinib, plus Imfinzi (durvalumab) to treat advanced papillary renal cell carcinoma patients.