▎WuXiEdited by Kant Content Team

Recently,AstraZeneca announced at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting plenary session that in the LAURA Phase III clinical trial, its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) statistically and clinically improved progression-free survival (PFS) by nearly 7 times compared to placebo in patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had undergone chemoradiotherapy (CRT) and whose tumors harbor epidermal growth factor receptor mutations (EGFRm). Detailed trial data were simultaneously published in The New England Journal of Medicine.

LAURA is a randomized, double-blind, placebo-controlled, global multicenter Phase III trial. The participants are patients with unresectable Stage III EGFR-mutated NSCLC whose disease has not progressed after receiving platinum-based CRT. Patients receive once-daily oral doses of 80 mg Tagrisso until disease progression, unacceptable toxicity, or meeting other discontinuation criteria.

The results assessed by the blinded independent central review (BICR) showed,Compared with placebo, Tagrisso reduced the risk of disease progression or death by 84% (HR=0.16; 95% CI: 0.10-0.24; p<0.001). The median PFS for patients treated with Tagrisso was 39.1 months, compared to 5.6 months in the placebo group.The proportion of patients in the Tagrisso group and placebo group who were alive and disease-free at 12 months was 74% (95% CI: 65-80) and 22% (95% CI: 13-32), respectively. Notably,A clinically meaningful PFS benefit was observed across all predefined subgroups, including gender, race, EGFR mutation type, age, smoking history, and prior CRT.

▲Summary of Efficacy Results from the LAURA Trial (Image Source: Reference [1])

Tagrisso group patients also showed a favorable trend in overall survival.The overall survival rates at 36 months were 84% (95% CI: 75-89) in the Tagrisso group and 74% (95% CI: 57-85) in the placebo group, not reaching statistical significance (HR=0.81, 95% CI: 0.42-1.56; p=0.53). However, the data was not yet mature at the time of analysis (data maturity 20%), and the trial will continue to evaluate changes in the secondary endpoint OS.

The safety results and discontinuation rates due to adverse events were as expected, with no new safety issues identified.In the Tagrisso group and placebo group, 35% and 12% of patients, respectively, experienced adverse events of grade 3 or higher due to various causes.

Tagrisso is a third-generation, irreversible EGFR-TKI that has been clinically proven to be effective against NSCLC.Tagrisso Approved Indications Include First-Line Treatment for Locally Advanced or Metastatic EGFRm NSCLC, First-Line Treatment for Locally Advanced or Metastatic EGFR T790M Mutation-Positive NSCLC Patients, and Adjuvant Treatment for Early-Stage (IB, II, and IIIA) EGFRm NSCLC. In August 2023, Tagrisso in Combination with Chemotherapy Received Breakthrough Therapy Designation from the U.S. FDA for First-Line Treatment of Adult Patients with Locally Advanced or Metastatic EGFRm NSCLC. In February this year, Tagrisso Combined with ChemotherapyFDA Approved, for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer。

References:

[1] TAGRISSO® (osimertinib) reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer vs. placebo in LAURA Phase III trial. Retrieved June 3, 2024 from https://www.businesswire.com/news/home/20240602348345/en

[2] Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Özgüroğlu M, Casarini I, Khiem DV, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS; LAURA Trial Investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Jun 2. doi: 10.1056/NEJMoa2402614. Epub ahead of print. PMID: 38828946.

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