5th Nov 2025 11:48
(Alliance News) - Hutchmed China Ltd on Wednesday said patient enrolment has been completed for its phase 3 Saffron trial evaluating the combination of Orpathys and Tagrisso in certain lung cancer patients, with topline results expected in the first half of 2026.
The Hong Kong-based developer of treatments for cancer and immunological diseases said the final patient was randomized on October 31 in the study, which is testing the combination in patients with epidermal growth factor receptor-mutated, MET-overexpressed or amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with Tagrisso.
The trial enrolled 338 patients across more than 230 sites in 29 countries and compares the Orpathys-Tagrisso combination with standard platinum-based doublet chemotherapy.
The study's primary endpoint is progression-free survival, assessed by independent central review.
Hutchmed said the combination offers a "promising, chemotherapy-free, all-oral treatment option" for patients who have relapsed after EGFR inhibitor therapy.
Orpathys, also known as savolitinib, is a selective MET inhibitor being co-developed and commercialised by Hutchmed and AstraZeneca PLC. Tagrisso, or osimertinib, is a third-generation EGFR tyrosine kinase inhibitor marketed by AstraZeneca.
The combination was approved in China in June 2025 based on results from an earlier phase 3 study, Sachii, which supported its use as a follow-on therapy after Tagrisso progression.
If results from Saffron are positive, Hutchmed said they could support global regulatory filings for the combination's approval.
Lung cancer remains the world's leading cause of cancer death, accounting for roughly one-fifth of all cancer-related deaths.
Hutchmed said the Saffron topline data are expected to be released in the first half of 2026, followed by a submission for presentation at a medical congress.
Hutchmed China shares were down 4.3% at 224.00 pence at midday in London on Wednesday.
By Eva Castanedo, Alliance News reporter
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