Lung Cancer Treatment Combo Submitted to FDA
The application seeks approval for a targeted therapy combination for patients with specific MET-driven lung cancer mutations.
Updated on Sept. 29, 2026 in Cancer
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AstraZeneca has submitted a new drug application to the FDA for the combination of savolitinib and osimertinib to treat adults with MET-driven, EGFR-mutated non-small cell lung cancer. This treatment is intended for patients whose disease has progressed following EGFR TKI therapy.
Why it matters
Approximately 34% of tumors develop MET overexpression or amplification as a resistance mechanism after treatment with third-generation EGFR inhibitors, making new strategies critical. This submission aims to offer an alternative for patients who no longer respond to standard targeted therapies.
Data from the phase 3 SACHI trial showed a median progression-free survival of 8.2 months for those receiving the combination, compared to 4.5 months for the chemotherapy group. Grade 3 or higher adverse events occurred in 57% of patients in both study arms.
The players
AstraZeneca
A global pharmaceutical company focused on the development of targeted therapies for oncology, including EGFR-mutated lung cancer treatments.
FDA
The United States federal agency responsible for evaluating the safety and efficacy of new drug applications.
The details
The treatment combines savolitinib, a selective MET tyrosine kinase inhibitor, with osimertinib, a third-generation EGFR inhibitor. This dual approach is designed to overcome resistance by simultaneously targeting the EGFR mutation and the MET overexpression that frequently emerges in these tumors. The SAFFRON trial utilized immunohistochemistry and fluorescence in situ hybridization to identify eligible patients with these specific gene or protein markers.
Timeline
August 2026: Companies reported high-level SAFFRON trial results.
September 29, 2026: Official submission and article publication.
Health Landscape
The use of combination therapies to address resistance marks a pivotal shift in the treatment of EGFR-mutated lung cancer. This approach follows the development of the SAFFRON clinical trial program as researchers look to mitigate common pathways of tumor progression.
If you or a loved one are managing EGFR-mutated lung cancer, discuss the status of emerging combination therapies with your oncologist. It is important to ask about biomarker testing for MET overexpression, which helps determine eligibility for specific resistance-focused treatments.
The takeaway
Targeting MET overexpression alongside EGFR mutations is a developing strategy for managing resistance in lung cancer patients. Patients and their medical teams should continue to monitor updates regarding trial data and potential regulatory approvals for these combination protocols.
What happens next
Full clinical trial results from the SAFFRON study are scheduled to be presented at the 2026 ESMO Congress.
Further reading
For more background on new treatment approaches, visit the Cancer section.
Source note: This article includes information reported by OncLive.
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