Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).
Specifically, the study will focus on patients with amplification of the MET gene who have had disease progression after receiving EGFR inhibitor therapy.
In June, Orpathys from AstraZeneca and HutchMed won conditional approval in China for patients with lung cancer with MET exon 14 skipping alterations. The drug is an oral MET tyrosine kinase inhibitor (TKI).
FDA and the E.U. first approved AstraZeneca’s Tagrisso in 2018. The drug is an irreversible epidermal growth factor receptor TKI. Last year, the drug brought in $4.32 billion in international revenue.
AstraZeneca and HutchMed dosed the first patient in the SACHI study
The clinical trial will pit the combination of Orpathys and Tagrisso against platinum-based doublet-chemotherapy, consisting of either pemetrexed paired with cisplatin or carboplatin.
The primary endpoint in the study will be median progression-free survival (PFS).
The two companies recently announced the launch of a separate Phase 3 study of the drug candidate Savolitinib in combination with the PD-L1 inhibitor Imfinzi in individuals with MET-driven advanced papillary renal cell carcinoma.