AstraZeneca, a global pharmaceutical company, has received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for Tagrisso (osimertinib) and platinum-based chemotherapy for the first line treatment of adults with locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).
This includes patients whose tumours have exon 19 deletions and exon 21 mutations.
The approval stemmed from the results of the Phase III FLAURA2 trial, which showed that Tagrisso with chemotherapy reduced disease progression and death risks by 38% compared to monotherapy — the current standard of care.
The median progression-free survival (PFS) was 25.5 months, which was an improvement of more than eight months compared to Tagrisso monotherapy.
Although it’s too early to determine the overall survival (OS) from the second interim analysis, a trend towards an OS benefit has been observed with the combination therapy versus Tagrisso alone.
Lung cancer remains a significant issue
Lung cancer remains as the most common cause of cancer-related deaths globally.1 It’s the second most prevalent cancer type in Japan, with more than 135,000 patients diagnosed yearly.2
Kunihiko Kobayashi, Professor at Saitama Medical University International Medical Center and a principal investigator in the trial, said: “The FLAURA2 results showed osimertinib with the addition of chemotherapy provided a nearly nine-month improvement in progression-free survival versus osimertinib monotherapy. This approval brings an important new treatment option for this aggressive form of lung cancer, the leading cause of cancer death in Japan.”
Tagrisso’s safety profile
The safety profile of Tagrisso plus 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 of Tagrisso due to AEs were 11% for Tagrisso plus chemotherapy and 6% for monotherapy.