AstraZeneca’s Tagrisso approved in Japan for 1st-line treatment

AstraZeneca’s Tagrisso, osimertinib, with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer, NSCLC, whose tumours have exon 19 deletions or exon 21 mutations. The approval by the Japanese Pharmaceuticals and Medical Device Agency, PMDA, was based on the results from the FLAURA2 Phase III trial, which were also published in The New England Journal of Medicine. Results showed Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care. Median progression-free survival was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy. PFS results by blinded independent central review were consistent with results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy. While the overall survival remained immature at the second interim analysis, an encouraging trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone, presented at the 2024 European Lung Cancer Congress in Prague, Czech Republic. The trial continues to assess OS as a key secondary endpoint.