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AstraZeneca reported new late-stage data at the European Lung Cancer Congress (ELCC 2025) supporting Tagrisso’s (osimertinib) role as a backbone therapy in EGFR-mutant non-small cell lung cancer (NSCLC), with results spanning monotherapy and combination use across stage 3 and advanced disease.
Tagrisso (osimertinib) is AstraZeneca’s third-generation EGFR tyrosine kinase inhibitor approved for the treatment of EGFR-mutated non-small cell lung cancer across multiple stages of disease. (Courtesy of AstraZeneca)
Tagrisso (osimertinib) is AstraZeneca’s third-generation EGFR tyrosine kinase inhibitor approved for the treatment of EGFR-mutated non-small cell lung cancer across multiple stages of disease. (Courtesy of AstraZeneca)
In the phase 3 LAURA trial, Tagrisso extended the trend toward improved overall survival (OS) in patients with unresectable, stage 3 EGFR-mutated NSCLC following concurrent chemoradiotherapy. Patients on Tagrisso lived a median 58.8 months compared with 54.1 months on placebo, despite nearly 80 percent of placebo patients crossing over to receive Tagrisso after progression. The hazard ratio landed at 0.67, though the data remain immature at 31 percent OS maturity.
The survival edge is particularly relevant in Korea, where EGFR mutations are more common than in Western populations—occurring in up to 50 percent of Asian patients compared to 10 to 15 percent of Caucasian patients, according to the NCCN Clinical Practice Guidelines for NSCLC.
Ahn Myung-ju, professor of hemato-oncology at Samsung Medical Center, Sungkyunkwan University School of Medicine, said in a statement, “A critical goal in treating every patient with lung cancer is to not only extend a patient’s life but also maintain quality of life while on treatment.”
She added, “The continued overall survival trend seen here at ELCC in the unresectable stage 3 setting and the promising data for combinations that can address progression in the advanced setting, together reinforce osimertinib as an effective, safe and convenient treatment for patients with EGFR-mutated lung cancer across stages and lines of treatment.”
Beyond monotherapy, AstraZeneca is preparing for resistance—rolling out combination data from the SAVANNAH and ORCHARD phase 2 trials that explore strategies to rescue patients who progress on first-line Tagrisso.
In SAVANNAH, the combo of Tagrisso and Orpathys (savolitinib) yielded a 56 percent objective response rate (ORR) in patients whose tumors had high MET overexpression or amplification. Median progression-free survival (PFS) came in at 7.4 months. Among patients screened, about 62 percent showed MET alterations, and one-third met the trial’s high MET cutoff.
Orpathys, developed by Hutchmed and AstraZeneca, is currently under evaluation in the phase 3 SAFFRON trial, which is expected to deliver data in the second half of 2025. The trial is testing a more frequent, twice-daily Orpathys regimen with Tagrisso in post-progression settings.
Meanwhile, in the ORCHARD platform study, AstraZeneca is betting on a TROP2-directed antibody-drug conjugate (ADC). The combination of Tagrisso with Datroway (datopotamab deruxtecan), the second ADC to come out of AstraZeneca and Daiichi Sankyo’s partnership, triggered a 43 percent ORR at a 4 mg/kg dose and 36 percent at 6 mg/kg. However, the higher dose led to deeper, longer responses. Median PFS reached 11.7 months for the 6 mg/kg group, with 64 percent of patients still responding at nine months, compared with 15 percent at the lower dose.
The combination’s toxicity was dose-dependent. Grade 3 or higher treatment-related adverse events hit 56 percent at the 6 mg/kg dose, versus 34 percent at the lower dose. Interstitial lung disease, a class-wide concern for ADCs like datopotamab deruxtecan, was observed in 15 percent of patients at the higher dose, including 6 percent at grade 3 or higher.
Finally, AstraZeneca shared updated post-hoc results from the FLAURA2 trial, which evaluated Tagrisso plus chemotherapy in the first-line setting. The combination showed a median PFS of more than two years, regardless of duration of pemetrexed maintenance treatment, with a trend toward longer PFS in patients who stayed on pemetrexed longer. Chemotherapy-related adverse events were manageable, with no new safety signals.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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