LONDON (dpa-AFX) - British drug major AstraZeneca Plc (AZN, AZN.L) announced Monday positive results from SAFFRON Phase III trial, with Tagrisso (osimertinib) plus Orpathys (savolitinib) demonstrating statistically significant and clinically meaningful improvements in epidermal growth factor receptor-mutated or EGFRm lung cancer.
Tagrisso plus Orpathys showed improvements in both progression-free survival or PFS and overall survival or OS in MET-driven EGFR-mutated lung cancer after progression on Tagrisso. This is compared to doublet platinum-based chemotherapy in patients with EGFRm non-small cell lung cancer or NSCLC.
Orpathys is being jointly developed by AstraZeneca and HUTCHMED (China) Ltd (HCM) and commercialised by AstraZeneca.
The company noted that SAFFRON is the first global Phase III trial to show significant progression-free and overall survival benefits in this setting.
Patients in the study had tumours with high levels of MET overexpression or amplification and had progressed on prior treatment with Tagrisso.
In the trial, the safety profile for Tagrisso plus Orpathys was consistent with the known profiles of each medicine, and there were no new safety findings.
The company said these data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, 'These data demonstrate the clear benefit of adding Orpathys to backbone therapy Tagrisso to address MET overexpression or amplification while maintaining EGFR suppression. By combining Orpathys and Tagrisso, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe.'
Tagrisso plus Orpathys 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.
The combination was also granted a temporary authorisation in Switzerland to treat patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with Tagrisso.
Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan.
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