Hutchmed (China) announced today that the SAVANNAH II phase study achieved positive summary results, showing a high and clinically significant improvement in objective response rate (ORR) in non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations who had disease progression after receiving previous treatment with Tagrisso (osimertinib) and Orpathys (savolitinib) combination therapy, and high levels of mesenchymal-epithelial transition factor ("MET") overexpression and/or amplification (defined as IHC90+ and/or FISH10+). The data will be presented at an upcoming scientific conference and shared with global regulatory institutions.

In 2023, the combination therapy of Tagrisso and Orpathys was granted Fast Track designation by the Food and Drug Administration (FDA) for this type of disease.

Orpathys is a potent, highly selective oral MET tyrosine kinase inhibitor (TKI) jointly developed by Astrazeneca and Hutchmed (China), with Astrazeneca responsible for commercialization. It has been approved in China for the treatment of non-small cell lung cancer patients with MET exon 14 skipping mutations who have progressed following systemic treatment or are ineligible for chemotherapy.

Although EGFR targeted therapy can bring significant survival benefits to non-small cell lung cancer patients with EGFR mutations, most patients eventually develop resistance to treatment, with MET being one of the common biomarkers associated with resistance. Among the patients screened for enrollment in the SAVANNAH study, an estimated 62% of patients' tumors had MET overexpression and/or amplification, with approximately 34% of patients reaching the defined high MET level threshold at clinical progression.

Professor Myung-Ju Ahn, the principal investigator of the SAVANNAH II study from Samsung Medical Center, Seoul National University College of Medicine in South Korea, stated: "Osimertinib has brought unprecedented survival rates to lung cancer patients with EGFR mutations and changed the treatment landscape. However, patients may develop resistance due to genes such as MET, a common biomarker associated with resistance. These results suggest that adding the selective MET inhibitor savolitinib to osimertinib treatment can provide meaningful disease relief for patients with disease progression, potentially offering a new treatment option after standard therapy with osimertinib."

Susan Galbraith, Executive Vice President and Head of Oncology Research at Astrazeneca, stated: " The positive results of the SAVANNAH studies indicate that targeted therapy can benefit EGFR mutation lung cancer patients with MET-driven resistance. Adding savolitinib in combination with the cornerstone therapy Tagrisso for EGFR mutation lung cancer can lead to a higher disease relief rate, further emphasizing the importance of identifying MET abnormalities and validating the feasibility of our combination therapy strategy to address resistance and continue treatment with Tagrisso."

Weiguo Su, CEO and Chief Scientific Officer of Hutchmed (China), stated: "The early results of the SAVANNAH II study provide an innovative biomarker approach to identify patients with MET overexpression and/or amplification who are most likely to benefit from MET-driven treatment, meeting a long-unmet need. These positive results provide further evidence for our patient-centric, selective treatment guidance, giving us hope to bring the first biomarker-driven targeted therapy treatment option for such diseases."

The safety profile of the combination therapy of Tagrisso and Orpathys is consistent with the known safety profiles of individual therapies and combination therapies. No new safety issues have been identified.