Hutchmed announces results from SAVANNAH trial

Hutchmed (HCM) announced high-level results from the SAVANNAH Phase II trial that showed Tagrisso plus Orpathys demonstrated a high, clinically meaningful and durable objective response rate, or ORR, for patients with epidermal growth factor receptor-mutated, or EGFRm, non-small cell lung cancer, or NSCLC, with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. In 2023, Tagrisso plus Orpathys received Fast Track designation from the FDA in this setting. Orpathys is an oral, potent, and highly selective MET tyrosine kinase inhibitor being jointly developed by AstraZeneca (AZN) and Hutchmed and commercialized by AstraZeneca. It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. While EGFR-targeted therapy can provide a substantial survival benefit to patients with EGFRm NSCLC, most will eventually develop resistance to their treatment, with MET being a common resistance biomarker. Among patients screened for enrollment in SAVANNAH, an estimated 62% had tumors with MET overexpression and/or amplification, and approximately 34% met the defined high MET level cut-off upon clinical progression. The safety and tolerability of Tagrisso plus Orpathys was consistent with the known safety profiles of the combination and each treatment alone. No new safety signals were identified. On August 2022, initial positive ORR results from the SAVANNAH trial were presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer, or WCLC. The global SAFFRON Phase III trial sponsored by AstraZeneca will further assess the Tagrisso plus Orpathys combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following Tagrisso. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.