HUTCHMED Announces Breakthrough Therapy Designation for ORPATHYS® and TAGRISSO® Combination for the treatment of EGFR+ NSCLC
HUTCHMED has announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for treating patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR inhibitor therapy. ORPATHYS® is a potent, selective MET tyrosine kinase inhibitor, while TAGRISSO® is a third-generation EGFR TKI.
This combination treatment is currently being studied in the Phase III SACHI trial, which compares ORPATHYS® and TAGRISSO® to standard chemotherapy (pemetrexed plus platinum) in patients with EGFR mutation-positive NSCLC and MET amplification after EGFR inhibitor failure. The study's primary endpoint is progression-free survival (PFS), with additional measures including overall survival (OS), objective response rate (ORR), and safety.
Lung cancer is the leading cause of cancer death, and about 30-40% of NSCLC patients in Asia have EGFR mutations. MET amplification is a common mechanism of resistance to EGFR inhibitors in NSCLC. Approximately 15-50% of patients who progress on osimertinib show MET aberration.
ORPATHYS® is an oral MET TKI that targets mutations, gene amplification, or protein overexpression. It is being developed for multiple cancers, including lung, kidney, and gastric cancersTAGRISSO® is an established EGFR TKI used to treat NSCLC and has shown clinical benefit across multiple stages of the disease.
The combination of ORPATHYS® and TAGRISSO® has already been tested in clinical trials like TATTON and SAVANNAH, showing promising results. The Phase III trials SACHI, SANOVO, and SAFFRON aim to further assess its efficacy in various patient groups.
