HUTCHMED and AstraZeneca begin Phase III trial of lung cancer treatment
pharmafile | November 24, 2021 | News story | Research and Development |
HUTCHMED Limited and AstraZeneca have initiated SACHI, a China Phase III study of Savolitinib (ORPATHYS®), an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI). This will be studied in combination with AstraZeneca’s third-generation, irreversible epidermal growth factor receptor (EGFR) TKI, TAGRISSO® (osimertinib).
The Phase III trial is a multi-center, open-label, randomised, controlled study in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC), with MET amplification after disease progression on EGFR inhibitor therapy.
The first patient received their dose on November 22, 2021.
The aim of the study is to evaluate the efficacy and safety of ORPATHYS® in combination with TAGRISSO®, compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard-of-care treatment option. The primary endpoint is median progression free survival (PFS).
Lung cancer is the leading cause of cancer death among men and women, and accounts for approximately one fifth of all cancer deaths. The disease is broadly split into NSCLC and small cell lung cancer, and 80-85% are classified as NSCLC. The majority of NSCLC patients are diagnosed with advanced disease, while about 25-30% have resectable disease at diagnosis.
Savolitinib has previously demonstrated clinical activity in advanced solid tumours, and blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs due to mutations or gene amplification. It is marketed in China under the brand name ORPATHYS®, for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialise savolitinib in 2011, and joint development in China is led by HUTCHMED while AstraZeneca leads development outside.
Lina Adams
