HUTCHMED (China) Limited and AstraZeneca have taken a major step toward bringing their targeted treatment combination for lung cancer to the US market.

 

This,with AstraZeneca submitting a New Drug Application to the US Food and Drug Administration for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib).

 

The application seeks approval for patients with locally advanced or metastatic non-small cell lung cancer whose tumors show MET overexpression or amplification and whose disease has progressed during or after treatment with an EGFR tyrosine kinase inhibitor.

 

The filing is backed by results from the global Phase III SAFFRON trial, which showed that the ORPATHYS–TAGRISSO combination delivered a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival compared with doublet platinum-based chemotherapy in patients whose disease progressed while receiving TAGRISSO.

 

The safety profile was consistent with the known profiles of the two medicines, with no new safety concerns reported.

 

The filing targets a major treatment challenge in EGFR-mutated NSCLC. While third-generation EGFR TKIs have substantially improved patient outcomes, MET overexpression or amplification is among the most common resistance mechanisms that emerge during treatment. MET-driven disease progression is linked to poor prognosis, underscoring the need for effective and tolerable treatment options.

 

Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: “This filing is an important step toward potentially bringing ORPATHYS plus TAGRISSO to patients in the US, after its approval in China based on the SACHI Phase III trial. 

 

"The success of the global SAFFRON Phase III trial reflects the long-standing collaboration between HUTCHMED and AstraZeneca in addressing MET-driven progression in EGFR-mutated lung cancer. We remain committed to supporting the regulatory review and making this biomarker-directed, chemotherapy-free oral combination available to eligible patients.”