Phase 3 FLAURA2 Trial: Final OS Analysis Shows Significant OS Improvement With Osimertinib Plus Chemotherapy for EGFR-Mutated NSCLC

Osimertinib plus pemetrexed and platinum-based chemotherapy showed a “statistically significant and clinically meaningful improvement” in overall survival (OS) compared with osimertinib monotherapy as first-line treatment for locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC), according to the final OS analysis of the phase 3 FLAURA2 trial.

“The final OS analysis demonstrates consistent survival benefit as previously reported in the interim OS results, and builds on the previously presented primary endpoint data, which demonstrated the longest-reported median progression-free survival (PFS) in this setting,” AstraZeneca officials said in an announcement of the results. OS was a “key secondary endpoint” in the trial, officials noted.

Pasi A. Jänne, MD, PhD, senior vice president for Translational Medicine and a thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, weighed in on the results in a statement provided by 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. Jänne said. “These positive results support osimertinib, 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.”

The longer follow-up data in the analysis also show that the safety profile of osimertinib plus chemotherapy “continues to be manageable and consistent with the established profiles of the individual medicines,” officials said. Adverse event (AE) rates were higher in the patients receiving osimertinib plus chemotherapy, which were “driven by well-characterised chemotherapy-related AEs,” officials said, noting that “discontinuation rates due to AEs and on-target toxicities were low in both arms of the trial.”

Susan Galbraith, executive vice president of Oncology Haematology R&D at AstraZeneca, also weighed in on the data in a statement provided by the company.

“These exciting overall survival results add to the extensive evidence supporting Tagrisso [osimertinib] 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,” Galbraith said. “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.”

These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities, according to AstraZeneca.