Health Canada approves Tagrisso® with the addition of chemotherapy for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly nine months compared to standard of care

MISSISSAUGA, ON, July 12, 2024 /CNW/ - Health Canada has granted a Notice of Compliance (NOC) for Tagrisso^® (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.¹ 

The approval of Tagrisso in combination with chemotherapy was granted based on the results from the FLAURA2 Phase III clinical trial, which was published in the New England Journal of Medicine in November 2023.² Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49, 0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).

The safety profile of Tagrisso with the addition of chemotherapy was consistent with the established profiles of the individual medicines. Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates for Tagrisso due to AEs were low in both arms of the trial (11% for Tagrisso plus chemotherapy and 6% for monotherapy). The most common adverse reactions of any grade (>10%) were leukocyte decreased (88%), platelet count decreased (86%), neutrophil decreased (85%), lymphocyte decreased (78%), rash (49%), diarrhea (44%), stomatitis (31%), paronychia (27%), dry skin (24%) and blood creatinine increased (22%). The most common adverse reactions grade 3 and above (>1%) were decreased neutrophils (36.0%), decreased leukocytes (20.0%), decreased platelets (16.4%), decreased lymphocytes (15.7%), diarrhea (2.9%) and rash (2.5%).²

"The FLAURA2 trial showed results demonstrating that patients experienced a significantly longer time without progression than those patients on standard of care," said Dr. Barbara Melosky, Medical Oncologist and Clinical Professor of Medicine at the University of British Columbia. "This approval is great news for physicians and patients and further helps us to match the right patient to the right treatment to get the best possible outcomes."

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.³ 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.⁴ As such, the 5-year survival rate for lung cancer is only 22% - significantly lower than prostate (91%), breast (89%) and colorectal (67%) cancers.³

"A lung cancer diagnosis can be devastating, and until we get better at diagnosing it earlier, those impacted by the disease need better treatment options," said Shem Singh, Executive Director, Lung Cancer Canada. "Having this new option available to Canadians living with lung cancer that effectively targets their specific type of lung cancer to help them live well longer is great news for the lung cancer community and another step in the right direction. We look forward to Canadians across the country being able to benefit from this treatment shortly."

About the FLAURA2 Trial¹

FLAURA2 is a randomized, open-label, multi-centre, global Phase III trial in the 1st-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFR-mutated (EGFRm) NSCLC. Patients were treated with Tagrisso 80mg once daily oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5)) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.

The trial enrolled 557 patients in more than 150 centres across more than 20 countries, including three centres in Canada. The primary endpoint is 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 more than 850,000 patients across its indications 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 approximately 1,800 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.

References

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	1 Tagrisso^®(osimertinib), Product Monograph, AstraZeneca Canada Inc., July 10, 2024.
	2 Planchard D, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med 2023;389:1935-1948.
	3 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.
	4 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.

Julie Holroyde, AstraZeneca Canada, Email: [email protected]