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.
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2 Planchard D, et
al. Osimertinib with or without Chemotherapy
in EGFR-Mutated Advanced NSCLC. N Engl J
Med 2023;389:1935-1948.
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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.
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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.
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SOURCE AstraZeneca Canada Inc.