HUTCHMED (00013) announces the completion of patient recruitment for the SAFFRON global Phase III study of the combination therapy of sulfasalazine and terizsa for specific lung cancer patients with MET overexpression and/or amplification after treatment with terizsa.

HUTCHMED (00013) announced that the SAFFRON study has completed patient enrollment. SAFFRON is a global Phase III study aimed at evaluating the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for the treatment of locally advanced or metastatic non-small cell lung cancer patients with epidermal growth factor receptor ("EGFR") mutations, with MET overexpression and/or amplification, who have progressed after treatment with TAGRISSO. The last patient for this study was enrolled on October 31, 2025. This combination therapy offers a promising oral treatment option without the need for chemotherapy for patients who have experienced disease progression after treatment with an EGFR tyrosine kinase inhibitor ("TKI"), and it was approved in China in June 2025 based on the results of the SACHI randomized Phase III study. ORPATHYS is a potent, highly selective oral MET TKI developed jointly by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is an irreversible third-generation EGFR TKI. The SAFFRON study is an open-label, randomized, global multicenter Phase III study aimed at evaluating the ORPATHYS plus TAGRISSO oral therapy compared to platinum doublet chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR mutations, with MET overexpression and/or amplification, who have progressed after first- or second-line treatment with TAGRISSO. The primary endpoint of the study is progression-free survival (PFS) assessed by blinded independent central review (BICR) based on RECIST 1.1 criteria. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. The study randomized 338 patients from over 230 research centers in 29 countries. Topline results of the SAFFRON study are expected to be announced in the first half of 2026, and the results will be subsequently submitted for publication at relevant academic conferences. If the results are favorable, the data is expected to support regulatory submissions for approval of the combination therapy of ORPATHYS and TAGRISSO to global regulatory agencies.