AstraZeneca's TAGRISSO Combination Therapy Extends Survival to Nearly Four Years in Advanced Lung Cancer

Key Insights

• AstraZeneca's FLAURA2 Phase III trial demonstrates that TAGRISSO combined with chemotherapy achieves a median overall survival of 47.5 months versus 37.6 months for TAGRISSO alone in EGFR-mutated non-small cell lung cancer patients.
• The combination therapy reduces the risk of death by 23% compared to monotherapy, with 63.1% of patients alive at three years versus 50.9% in the monotherapy arm.
• Safety profile remains manageable with 70% of combination patients experiencing grade 3 or higher adverse events, primarily driven by well-characterized chemotherapy-related effects.

AstraZeneca has announced positive results from the final overall survival analysis of the FLAURA2 Phase III trial, showing that TAGRISSO (osimertinib) combined with pemetrexed and platinum-based chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival compared to TAGRISSO monotherapy in patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Survival Outcomes Show Substantial Benefit

The final overall survival analysis revealed that TAGRISSO plus chemotherapy demonstrated a median overall survival of nearly four years (47.5 months) compared to approximately three years (37.6 months) for TAGRISSO monotherapy. At 57% data maturity, the combination therapy reduced the risk of death by 23% compared to TAGRISSO alone.

Long-term survival rates further underscore the clinical significance of the combination approach. An estimated 63.1% of patients treated with the combination were alive at three years and 49.1% were alive at four years, compared to 50.9% and 40.8%, respectively, in the monotherapy arm.

Consistent Benefits Across Patient Populations

The observed overall survival benefit for TAGRISSO plus chemotherapy versus TAGRISSO monotherapy was consistent across all prespecified subgroups, indicating broad applicability of the treatment approach. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the clinical relevance of the overall survival results.

Safety Profile Remains Manageable

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 from all causes were reported in 70% of patients receiving the combination therapy, primarily driven by well-characterized chemotherapy-related adverse events. In comparison, 34% of patients in the TAGRISSO monotherapy arm experienced grade 3 or higher adverse events, consistent with rates observed in the primary analysis.

The FLAURA2 trial evaluated the combination therapy as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer, representing a significant advancement in the treatment landscape for this patient population.