AstraZeneca's TAGRISSO Combo Delivers Survival Advantage In EGFRm NSCLC Phase III Trial

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(RTTNews) - AstraZeneca (AZN) announced positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial, demonstrating that TAGRISSO (osimertinib) combined with pemetrexed and platinum-based chemotherapy achieved a statistically significant and clinically meaningful improvement in OS compared to TAGRISSO monotherapy. The combination therapy was evaluated as a 1st-line treatment for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

In the final OS analysis, TAGRISSO plus chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for TAGRISSO monotherapy. At 57% data maturity, results showed TAGRISSO plus chemotherapy reduced the risk of death by 23% compared to TAGRISSO monotherapy. An estimated 63.1% of patients treated with the combination were alive at three years and 49.1% of patients were alive at four years compared to 50.9% and 40.8%, respectively, in the monotherapy arm. Importantly, the observed OS benefit for TAGRISSO plus chemotherapy versus TAGRISSO monotherapy was consistent across all prespecified subgroups. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the relevance of the OS results.

With longer follow-up, the safety profile of TAGRISSO plus chemotherapy remained manageable and aligned with the known profiles of the individual agents. Grade 3 or higher adverse events (AEs) from all causes were reported in 70% of patients receiving the combination therapy, primarily driven by well-characterized chemotherapy-related AEs. In comparison, 34% of patients in the TAGRISSO monotherapy arm experienced Grade =3 AEs—consistent with rates observed in the primary analysis presented at IASLC 2023 WCLC (64% vs. 27%, respectively).

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