Tagrisso Shows Notable Tumor Shrinkage in Clinical Trial
- Patients with stage II to IIIB non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) gene mutation had better outcomes when treated with Tagrisso (generic name: osimertinib) before surgery compared to chemotherapy alone, according to research presented at 2025’s American Society of Clinical Oncology (ASCO) conference.
- The promising data indicates that adding the the drug, a targeted therapy known as a tyrosine kinase inhibitors (TKI), before surgery leads to significantly higher rates of tumor shrinkage than chemotherapy.
- The drug binds to the mutated epidermal growth factor receptor (EGFR) protein on the surface of cancer cells, preventing the protein from being activated. This blocks the molecular signals that lead to uncontrolled cancer growth.
This treatment led to a significantly higher rate of tumor shrinkage before surgery, according to new research published in the Journal of Clinical Oncology and presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.
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“Tagrisso is one of the very effective EGFR targeting agents used widely in cases of advanced/stage IV EGFR-positive lung cancer,” Dr. Halmos says.
The new research highlights the drug’s potential in earlier-stage disease — and when given in the neoadjuvant setting, which means before surgery.
Osimertinib (Tagrisso), a targeted therapy, may be familiar to some lung cancer patients as it first received approval from the Food and Drug Administration (FDA) in 2015. Since then, researchers have continuously tried to find more effective ways to use it to help patients with non-small cell lung cancer, the most common type of lung cancer.
It belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). The drug binds to the mutated EGFR protein on the surface of cancer cells, preventing the protein from being activated. This blocks the molecular signals that lead to uncontrolled proliferation, ultimately inhibiting cancer growth and survival.
WATCH: Implementing targeted therapy into lung cancer care.
What Did The Data Show?
In the recently published study, 358 stage II to IIIB lung cancer patients with resectable (operable) lung cancer that had the EGFR mutation were randomly assigned to receive osimertinib and platinum-based chemotherapy, osimertinib as a monotherapy (single drug treatment), or placebo plus platinum-based chemotherapy before surgery.
Platinum-based chemotherapy means platinum is used in the chemo anti-cancer medicine. Non-platinum-based chemo exists as well when the cancer proves to be platinum-resistant.
Patients on the osimertinib-plus-chemotherapy and the osimertinib monotherapy regimen saw a significant reduction in tumor cells after treatment (also called a major pathological response or MPR) compared to chemotherapy alone.
The osimertinib-plus-chemotherapy group had an MPR rate of 26% and the osimertinib alone group had 25% — while the placebo group had an MPR of just 2%.
The data also indicated patients receiving the targeted therapy before surgery had better event-free survival.
Questions To Ask Your Doctor?
- Am I eligible for osimertinib?
- Should we add osimertinib to my treatment plan?
- Are there safety concerns I should be aware of?
- Does my insurance cover this drug?
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