2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.050 Zofia Piotrowska NACLC23 Abstract

PP01.050 Zofia Piotrowska NACLC23 Abstract

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The SAFFRON study aims to assess the efficacy and safety of the combination of savolitinib and osimertinib compared to platinum-based chemotherapy in patients with EGFRm NSCLC who have MET overexpression or amplification and have progressed on osimertinib. Osimertinib is currently the preferred first-line treatment for this type of lung cancer, but patients eventually develop resistance, with MET overexpression/amplification being the most common resistance mechanism. Savolitinib is a highly selective MET-TKI that has shown promise in combination with osimertinib in previous studies.<br /><br />The SAFFRON study is a phase 3, open-label study that will randomize 324 patients from 29 countries. Patients must have disease progression on first or second-line treatment with osimertinib, and MET overexpression/amplification will be determined by central IHC or FISH. Patients will be randomized to receive either oral savolitinib 300 mg twice-daily with osimertinib 80 mg once-daily or IV chemotherapy with pemetrexed and either carboplatin or cisplatin. Treatment will continue until disease progression or unacceptable toxicity.<br /><br />The primary endpoint of the study is progression-free survival, with secondary endpoints including overall survival, PFS in patients with MET overexpression, objective response rate, duration of response, pharmacokinetics, and safety/tolerability. A planned exploratory analysis will investigate treatment response and resistance mechanisms using patients' samples.<br /><br />The investigators hope that the combination of osimertinib and savolitinib will address the high unmet need in patients with EGFRm NSCLC who develop resistance to osimertinib. The primary analysis of the SAFFRON study is expected in mid-2025.<br /><br />Keywords: NSCLC, osimertinib, savolitinib.

Keywords

SAFFRON study

osimertinib

savolitinib

EGFRm NSCLC

MET overexpression

MET amplification

lung cancer

progression-free survival

chemotherapy

resistance mechanisms