Tagrisso + savolitinib demonstrated 49% objective response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial.
Preliminary results from the SAVANNAH Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate (ORR) of 49% (95% confidence interval [CI], 39-59%) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso
The highest ORR was observed in patients with high levels of MET who were not treated with prior chemotherapy (52% [95% CI, 41-63%]). In patients whose tumours did not show high levels of MET, the ORR was 9% (95% CI, 4-18%). These results are being shared at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer, taking place 6-9 August in Vienna, Austria.
In this analysis, patients’ MET overexpression and/or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridisation (FISH), which detects a specific DNA sequence from cancer cells. All patients in this analysis (n=193) had at least IHC50+ and/or FISH5+, and were treated with savolitinib 300mg once daily added to Tagrisso 80mg once daily following disease progression on Tagrisso alone.
The safety profile of Tagrisso plus savolitinib was consistent with the known profiles of the combination and each treatment alone. No new safety signals were identified. Less than half (45%) of patients in this analysis experienced Grade 3 or higher adverse events (AEs), with those most frequently reported including pulmonary embolism, dyspnoea, decreased neutrophil count and pneumonia. AEs attributable to savolitinib and leading to discontinuation occurred in 13% of patients.
The global SAFFRON Phase III trial will further assess the Tagrisso plus savolitinib 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.
In December 2011 AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialise savolitinib. Joint development of savolitinib in China is led by Hutchmed, while AstraZeneca leads development outside of China. Hutchmed is responsible for the marketing authorisation, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialisation of savolitinib in China and worldwide. Sales of savolitinib are recognised by AstraZeneca.
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