(RTTNews) - HUTCHMED (China) Ltd (HCM), a commercial-stage company, announced positive results from the SAFFRON Phase III trial evaluating ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in patients with epidermal growth factor receptor-mutant non-small cell lung cancer.
According to the company, the combo demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients.
Lung cancer is one of the leading causes of cancer death globally.
ORPATHYS (savolitinib) is an oral, highly selective MET TKI that has demonstrated clinical activity in advanced solid tumours and is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with the MET exon 14 skipping alteration.
ORPATHYS is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
AstraZeneca's TAGRISSO has approved indications for locally advanced or metastatic EGFRm NSCLC; locally advanced or metastatic EGFR T790M mutation-positive NSCLC; adjuvant treatment of early-stage EGFRm NSCLC; and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy.
ORPATHYS plus TAGRISSO is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.
SAFFRON is a randomised, open-label, multi-centre, global Phase III trial studying the efficacy of ORPATHYS (300mg twice daily) added to TAGRISSO (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO.
The trial included patients with tumours showing high levels of MET overexpression or amplification who had progressed on prior treatment with TAGRISSO.
According to the company, the phase 3 trial showed significant improvements in progression-free survival and overall survival in this setting.
In addition, the safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each medicine, with no new safety findings.
HCM has traded between $9.77 and $18.30 over the last year. The stock closed Friday's trade at $12.20, up 0.33%.
In the overnight market, HCM is up 6.39% to $12.98.
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