Health Canada approves Tagrisso with chemotherapy for advanced EGFR-mutated lung cancer

Health Canada has recently approved Tagrisso® (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) possessing EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. This decision follows the findings from the FLAURA2 Phase III clinical trial, which highlighted significant improvements in patient outcomes when Tagrisso is paired with chemotherapy.

The FLAURA2 trial, published in the New England Journal of Medicine in November 2023, demonstrated that adding chemotherapy to Tagrisso reduced the risk of disease progression or death by 38% compared to Tagrisso alone. Specifically, the median progression-free survival (PFS) for patients receiving the combination treatment was 25.5 months, an increase of 8.8 months compared to the 16.7 months observed with Tagrisso monotherapy.

In terms of safety, the adverse events (AEs) associated with the combination therapy were consistent with known profiles of the individual drugs. While the combination therapy did lead to higher rates of adverse events, these were mainly related to chemotherapy. Discontinuation rates due to adverse events were relatively low for both groups, with 11% for the combination therapy and 6% for Tagrisso alone. Common adverse reactions included decreased white blood cells, platelets, and neutrophils, as well as rash, diarrhea, and stomatitis.

Dr. Barbara Melosky, a Medical Oncologist and Clinical Professor of Medicine at the University of British Columbia, emphasized that the FLAURA2 trial results show a significant improvement in progression-free survival for patients. She noted that the approval of this combination therapy is a positive development for both physicians and patients, allowing for better-matched treatments and improved outcomes.

Lung cancer continues to be the most diagnosed cancer in Canada, excluding non-melanoma skin cancers, and it remains the leading cause of cancer-related deaths in the country. The majority of lung cancer cases in Canada are diagnosed at advanced stages (III or IV), significantly reducing survival rates and shifting the treatment goal from curative to palliative. The five-year survival rate for lung cancer is notably low at 22%, compared to higher survival rates for prostate, breast, and colorectal cancers.

Shem Singh, Executive Director of Lung Cancer Canada, highlighted the importance of this new treatment option for those living with lung cancer in Canada. Singh stressed that while early diagnosis remains a challenge, having effective treatment options for advanced cases is crucial for improving patient outcomes. He expressed optimism that Canadians across the country would soon benefit from this new therapy.

The FLAURA2 trial is a global, randomized, open-label Phase III study involving 557 patients from over 20 countries, including Canada. The trial focuses on patients with locally advanced or metastatic EGFR-mutated NSCLC and aims to assess both progression-free survival and overall survival.

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI known for its efficacy in treating NSCLC, including cases with central nervous system metastases. This medication has been administered to over 850,000 patients worldwide.

AstraZeneca, the company behind Tagrisso, is a global biopharmaceutical leader focused on oncology, cardiovascular, renal and metabolic diseases, rare diseases, respiratory and immunology, and vaccine and immune therapies. Recently, AstraZeneca announced an expansion of its research facilities in Mississauga, aiming to bolster its research footprint in Canada.

The approval of Tagrisso in combination with chemotherapy represents a significant advancement in the treatment of advanced lung cancer, offering hope for improved patient outcomes and survival rates.