{"id":1003094,"date":"2026-09-13T21:50:01","date_gmt":"2026-09-14T01:50:01","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tagrisso-osimertinib-demonstrated-unprecedented-eight-year-landmark-survival-in-early-stage-egfr-mutated-lung-cancer-in-adaura-phase-iii-trial\/"},"modified":"2026-09-13T21:50:01","modified_gmt":"2026-09-14T01:50:01","slug":"tagrisso-osimertinib-demonstrated-unprecedented-eight-year-landmark-survival-in-early-stage-egfr-mutated-lung-cancer-in-adaura-phase-iii-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tagrisso-osimertinib-demonstrated-unprecedented-eight-year-landmark-survival-in-early-stage-egfr-mutated-lung-cancer-in-adaura-phase-iii-trial\/","title":{"rendered":"TAGRISSO\u00ae (osimertinib) demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial"},"content":{"rendered":"

<\/p>\n

TAGRISSO\u00ae<\/sup> (osimertinib) demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial<\/b><\/p>\n

Longest survival data ever reported in a global Phase III trial in this setting<\/i><\/b><\/p>\n

New data reinforce TAGRISSO as the standard of care and backbone <\/i>therapy in EGFRm lung cancer across stages<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nUpdated exploratory results from the ADAURA Phase III trial showed AstraZeneca\u2019s TAGRISSO\u00ae<\/sup> (osimertinib) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at eight years compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFR<\/i>m) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.<\/p>\n

\nThese results were presented today during the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer (#WCLC26) hosted by the International Association for the Study of Lung Cancer in Seoul, Republic of Korea (Abstract PL03.01). These data were also simultaneously published in the Journal of Thoracic Oncology<\/i><\/a>.<\/p>\n

\nAt eight years of follow-up, results showed that TAGRISSO continued to show an OS benefit, reducing the risk of death compared to placebo by 47% in the primary population (Stages II-IIIA) (based on a hazard ratio [HR] of 0.53; 95% confidence interval [CI] 0.38-0.75). In the overall trial population (Stages IB-IIIA), TAGRISSO reduced the risk of death compared to placebo by 48% (HR 0.52; 95% CI 0.39-0.71). An estimated 74% of patients treated with TAGRISSO were alive at eight years versus 58% of those treated with placebo in the primary population. In the overall trial population, an estimated 79% of patients treated with TAGRISSO were alive at eight years versus 64% of those treated with placebo. Consistent with the planned final analysis, OS benefit with TAGRISSO versus placebo was observed across all predefined subgroups.<\/p>\n

\nRoy S. Herbst, MD, PhD, Director at Dartmouth Cancer Center, and principal investigator in the ADAURA Phase III trial, said: \u201cThese ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib, with a 16 percent point improvement in overall survival at eight years versus placebo. This is especially impressive given high rates of crossover to osimertinib following disease recurrence. This durable overall survival benefit reinforces the importance of prioritizing EGFR<\/i> testing at diagnosis so as many patients as possible can benefit from this transformative therapy.\u201d<\/p>\n

\nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \u201cADAURA continues to set new benchmarks in early-stage EGFR<\/i>-mutated lung cancer, with nearly 80 percent of patients treated with adjuvant TAGRISSO alive at eight years. These results underscore the importance of treating early and reinforce TAGRISSO as the adjuvant standard of care and backbone therapy across stages of the disease.\u201d<\/p>\n

Summary of updated OS results: ADAURAi,ii<\/sup><\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0<\/p>\n<\/td>\n

\n

TAGRISSO<\/b><\/p>\n<\/td>\n

\n

Placebo<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Stages II-IIIA (primary population)<\/b><\/p>\n<\/td>\n

\n

(n=233)<\/b><\/p>\n<\/td>\n

\n

(n=237)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian duration of follow-up, in months<\/p>\n<\/td>\n

\n

\n92<\/p>\n<\/td>\n

\n

\n68.5<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS HR (95% CI)<\/p>\n<\/td>\n

\n

\n0.53 (0.38, 0.75)<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS rate at 96 months (95% CI), %<\/p>\n<\/td>\n

\n

\n74 (67, 80)<\/p>\n<\/td>\n

\n

\n58 (50, 65)<\/p>\n<\/td>\n<\/tr>\n

\n

Stage IB-IIIA (overall population)<\/b><\/p>\n<\/td>\n

\n

(n=339)<\/b><\/p>\n<\/td>\n

\n

(n=343)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian duration of follow-up, in months<\/p>\n<\/td>\n

\n

\n93.3<\/p>\n<\/td>\n

\n

\n79.6<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS HR (95% CI)<\/p>\n<\/td>\n

\n

\n0.52 (0.39, 0.71)<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS rate at 96 months (95% CI), %<\/p>\n<\/td>\n

\n

\n79 (74, 83)<\/p>\n<\/td>\n

\n

\n64 (58, 70)<\/p>\n<\/td>\n<\/tr>\n

\n

\ni The updated analysis data cut-off (DCO) date was May 4, 2026.<\/p>\n

\nii This exploratory long-term OS analysis was conducted in all randomized patients. 127 patients did not have additional survival data and remained censored, with survival time unchanged from the planned final OS analysis until May 4, 2026.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nFinal safety data for ADAURA were collected at the planned final OS analysis, at which time the safety and tolerability of TAGRISSO were consistent with its established profile with no new safety concerns.<\/p>\n

\nComplementing the ADAURA clinical trial findings, real-world evidence presented at WCLC26 from a retrospective cohort study of US patients with early-stage (I-IIIA) EGFR<\/i>m NSCLC (Abstract P1.142) showed that early discontinuation of TAGRISSO before completion of the three-year treatment course more than doubled the risk of disease recurrence or death. These results reinforce the importance of maintaining the full treatment duration established in ADAURA and underscore the need for clinician-patient communication to support treatment persistence.<\/p>\n

\nIn the advanced disease setting, additional data presented at WCLC26 from the FLAURA2 Phase III trial reinforced the benefits of backbone therapy TAGRISSO in combination with platinum-pemetrexed chemotherapy in patients with 1st-line advanced EGFR<\/i>m NSCLC. Results from a novel safety analysis (Abstract PT2.03.03) showed that with long-term follow-up (median 42.6 months), the safety and tolerability of TAGRISSO plus platinum\u2013pemetrexed remained consistent with the established safety profiles of these medicines, with clear reductions in new adverse event onset following the initial induction period. Additionally, an exploratory analysis (Abstract P2.237) showed that progression-free survival and OS HRs numerically favored TAGRISSO plus platinum\u2013pemetrexed versus TAGRISSO monotherapy regardless of baseline TP53 co-mutation status.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n