Tagrisso® approved (with conditions) in Canada for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC)

Based on LAURA Phase III trial results which showed patients who took TAGRISSO after CRT had a median progression-free survival of more than 3 years

MISSISSAUGA, ON, May 21, 2025 /CNW/ - Health Canada has granted a Notice of Compliance with conditions (NOC/c) for Tagrisso^® (osimertinib) for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. A validated test is required to identify EGFR mutation-positive status prior to treatment.¹

The conditional approval was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.²

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.² Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.²

Each year in Canada, 32,000 people are diagnosed with lung cancer³, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.⁴ Approximately 15% of NSCLC patients in Canada have EGFR mutations.⁵ Nearly one in five people diagnosed with NSCLC has an unresectable tumour.⁶

"With this approval, we're now able to offer people living with Stage III, EGFR-mutated NSCLC an oral targeted therapy," says Dr. Paul Wheatley-Price, Associate Professor of Medicine at the University of Ottawa and Medical Oncologist at the Ottawa Hospital, and host of the Lung Cancer Voices podcast. "The LAURA trial demonstrated that with Tagrisso, patients were able to live, on average, for more than three years without disease progression, which is an impressive result in this patient population."

"With the approval of Tagrisso, we have a new approach for managing unresectable Stage III non-small cell lung cancer with EGFR mutations," says Dr. Nathalie Daaboul, hemato-oncologist at the Centre intégré de cancérologie de la Montérégie, University of Sherbrooke. "The LAURA trial results reinforce the potential benefits of Tagrisso after CRT, offering hope for extended progression free survival and improved outcomes, which is good news for patients."

The safety profile of Tagrisso in this disease setting was manageable and was consistent with Tagrisso monotherapy and the known safety profile of treatment following platinum-based chemoradiation therapy. The discontinuation rate for Tagrisso due to AEs was 8.4%. The most common adverse reactions of any grade (>10%) were radiation pneumonitis (48.3%), diarrhea (35.7%), rash (35.7%), paronychia (23.1%), dry skin (17.5%), stomatitis (15.4%) and pruritus (12.6%). The most common adverse drug reactions grade 3 and above (>1%) were diarrhea (2.1%), radiation pneumonitis (2.1%) and ILD (1.4%).² 

"We're pleased to see that Health Canada has recognized the efficacy of Tagrisso demonstrated in the LAURA study," says Shem Singh, Executive Director, Lung Cancer Canada. "The ability for people with lung cancer to have more time living life without their cancer progressing is so important for their quality of life and that of their family, and this new treatment option will be welcome news for those with stage III EGFR-mutated NSCLC."

About Lung Cancer
Lung cancer remains the most diagnosed cancer in Canada (excluding non-melanoma skin cancers) and is the leading cause of death from cancer in this country.⁷ In Canada, roughly two-thirds (70%) of lung cancer cases are diagnosed in stages III or IV where the disease has already spread locally or metastasized, resulting in poorer survival outcomes and the treatment goal is no longer curative.⁸ As such, the 5-year survival rate for lung cancer is only 22% - significantly lower than prostate (91%), breast (89%) and colorectal (67%) cancers.⁷

About LAURA²
LAURA is a randomized, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso.

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat approximately 1,000,000 patients since launch worldwide.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer.

AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at www.astrazeneca.ca.

Tagrisso^® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

References
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¹ Tagrisso (osimertinib), Product Monograph, AstraZeneca Canada Inc., April 23, 2025.
² Lu S., et al. Osimertinib After Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. The New England Journal of Medicine. 2024; 391(7): 585-297.
³ Lung Cancer Canada. Facts About Lung Cancer. Available at: https://lungcancercanada.ca/about-lung-cancer/facts-about-lung-cancer/. Accessed on March 11, 2025.
⁴ Lung Cancer Canada. Your Comprehensive Guide to Lung Cancer – Types of Lung Cancer. Available at: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://lungcancercanada.ca/assets/ documents/patients-guide-english.pdf. Accessed on March 11, 2025.
⁵ O'Sullivan DE, et al. Prevalence, Treatment Patterns, and Outcomes of Individuals with EGFR Positive Metastatic Non-Small Cell Lung Cancer in a Canadian Real-World Setting: A Comparison of Exon 19 Deletion, L858R, and Exon 20 Insertion EGFR Mutation Carriers. Current Oncology. 2022; 29: 7198-7208.
⁶ Seung SJ, et al. Restrospective Cohort Study of Unresectable Stage III Non-Small Cell Lung Cancer in Canada. Current Oncology. 2020 Aug; 27(4) e354-e360.
⁷ Lung Cancer Canada. Hard Facts Poster, 2023. Available at: https://www.lungcancercanada.ca/en-CA/Resources/The-Hard-Facts-Poster.aspx. Accessed on June 12, 2024.
⁸ Canadian Partnership Against Cancer. Lung Cancer and Equity Report – Diagnosis and Treatment. Available at: https://www.partnershipagainstcancer.ca/topics/lung-cancer-equity/diagnosis-treatment/. Accessed on June 12, 2024.

SOURCE AstraZeneca Canada Inc.

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