Results from a prespecified exploratory analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO with the addition of chemotherapy demonstrated a 42% improvement in central nervous system progression-free survival, compared to TAGRISSO alone for patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer and brain metastases at baseline, representing 40% of patients in the trial, as assessed by blinded independent central review. These results were presented in an oral presentation at the European Society for Medical Oncology Congress in Madrid, Spain. In this group of patients, TAGRISSO with the addition of chemotherapy reduced the risk of CNS disease progression or death by 42% compared to TAGRISSO alone as assessed by BICR. With two years of follow-up, 74% of patients treated with TAGRISSO plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with TAGRISSO monotherapy. Results also showed a higher proportion of patients demonstrated CNS complete response with TAGRISSO plus chemotherapy versus TAGRISSO alone. The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines. Adverse event rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. TAGRISSO discontinuation rates were low in both arms of the trial. In the TAGRISSO plus chemotherapy arm, patients remained on TAGRISSO for a median duration of 22.3 months, while patients had a median exposure to platinum-based chemotherapy of 2.8 months and a median exposure to pemetrexed of 8.3 months.
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