Can Tagrisso Plus Chemo Help Patients With Lung Cancer Live Longer?

Tagrisso with chemo significantly improved survival and progression-free outcomes versus Tagrisso alone in newly diagnosed advanced EGFR-mutated lung cancer: © stock.adobe.com.

Adding chemotherapy to Tagrisso (osimertinib) improved overall survival for patients with newly diagnosed, advanced EGFR-mutated non-small cell lung cancer compared with Tagrisso alone, according to a news release from AstraZeneca.

“When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in 1st-line where treatment duration can be long and many patients remain active,” Dr. Pasi A. Jänne said in the news release. “These positive results support [Tagrisso], either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression.”

Jänne is the senior vice president for Translational Medicine and thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial

The final overall survival (OS) analysis demonstrated a consistent survival benefit with Tagrisso plus chemotherapy, confirming the trend seen in the interim results and building on previously reported primary endpoint data, which showed the longest median progression-free survival (PFS) reported in this setting.

At the time of the interim analysis, conducted with 41% data maturity, Tagrisso plus chemotherapy showed a favorable OS trend versus Tagrisso alone, with consistent benefit across prespecified subgroups, including sex, race, EGFR mutation type, age, smoking history, performance status and presence of brain metastases. While the OS results were not statistically significant at the interim analysis, they were supported by key post-progression outcomes.

Tagrisso plus chemotherapy showed consistent benefit across time to first subsequent treatment, time to progression on second-line therapy and time to second subsequent treatment. As the primary end point, PFS was significantly improved with the combination, reducing the risk of disease progression or death by 38%. Median PFS was extended by 8.8 months by investigator assessment and by 9.5 months per blinded independent central review. A clinically meaningful PFS benefit was observed across all prespecified subgroups.

With extended follow-up, Tagrisso plus chemotherapy showed a safety profile that remained in line with known effects of each drug. While side effects occurred more often with the combination, largely due to chemotherapy, both groups had low rates of treatment discontinuation from side effects or drug-related toxicities.

“These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease,” Susan Galbraith, executive vice president, Oncology Haematology R&D, AstraZeneca, said in the news release. “With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment.”

Tagrisso is a third-generation EGFR-targeted therapy approved in over 120 countries for treating EGFR-mutated non-small cell lung cancer (NSCLC) across multiple stages. It is available as 40 mg and 80 mg once-daily tablets and has been used by more than one million patients worldwide.

The phase 3 FLAURA2 trial is a randomized, open-label, multi-center study investigating first-line treatment for patients with locally advanced (stage 3B–3C) or metastatic (stage 4) EGFR-mutated non-small cell lung cancer. Patients received Tagrisso (80 milligrams [mg] once daily) plus chemotherapy — Alimta (pemetrexed: 500 mg per square meter [mg/m2]) with either cisplatin (75 mg/m²) or Paraplatin (carboplatin) — every three weeks for four cycles, followed by maintenance treatment with Tagrisso and Alimta every three weeks.

The trial enrolled 557 patients across more than 150 centers in over 20 countries, including in the U.S., Europe, South America and Asia. The primary endpoint is progression-free survival, with overall survival as the key secondary endpoint.

References

1. "Tagrisso plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer," AstraZeneca, March 10, 2025
2. "Tagrisso with the addition of chemotherapy showed favourable trend in overall survival in EGFR-mutated advanced lung cancer with further follow-up from FLAURA2 Phase III trial," AstraZeneca, May 22, 2024
3. "Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial," AstraZeneca, June 2, 2023

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