Osimertinib Plus Chemotherapy Improves PFS vs Osimertinib Alone in EGFRm NSCLC

Osimertinib (Tagrisso; AstraZeneca) plus chemotherapy showed a statistically significant improvement in progression-free survival (PFS) vs osimertinib alone in patients with epidermal growth factor receptor–mutated (EGFRm) advanced non–small cell lung cancer (NSCLC), according to a news release from AstraZeneca.

The data, which will be presented in full at an upcoming medical meeting, are a product of the randomized, open-label, phase 3 FLAURA2 trial of osimertinib with or without chemotherapy as first-line treatment for locally advanced or metastatic EGFRm NSCLC.

Overall survival (OS) data were immature at the time of the analysis but will be assessed in a later analysis. No new safety signals with either therapy were identified.

“As the global standard of care for EGFR-mutated non–small cell lung cancer, osimertinib monotherapy has transformed the treatment landscape allowing many patients the opportunity to achieve improved survival,” Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said in the statement. “FLAURA2 provides compelling evidence that the addition of chemotherapy to osimertinib can provide a new option for patients and clinicians that further improves outcomes compared to osimertinib alone, and as such, can further delay treatment resistance and disease progression.”

Osimertinib is approved for the treatment of EGFRm NSCLC in several settings, and ongoing studies are exploring additional indications. Current approved indications include:

• Adjuvant therapy after tumor resection in adult patients with EGFRm NSCLC
• First-line treatment of adult patients with metastatic EGFRm NSCLC
• Treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy

The FLAURA2 results add to a growing body of evidence supporting the use of osimertinib in EGFRm NSCLC in both early- and late-stage disease.

FLAURA2 is an international phase 3 trial of 586 patients with locally advanced or metastatic EGFRm NSCLC. Patients were randomized to treatment with either osimertinib alone or osimertinib plus chemotherapy with pemetrexed plus cisplatin or carboplatin every 3 weeks for 4 treatment cycles.

Patients at more than 150 centers in more than 20 countries were enrolled in the study, which has a primary end point of PFS and a secondary end point of OS.

“These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a statement. “This meaningfully builds on successive trials, which have demonstrated improved clinical benefit with TAGRISSO in patients with EGFR-mutated lung cancer.”​

Reference

Tagrisso (osimertinib) plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial. News release. AstraZeneca. May 17, 2023. Accessed May 17, 2023. https://www.astrazeneca-us.com/media/press-releases/2023/tagrisso-osimertinib-plus-chemotherapy-demonstrated-strong-improvement-in-progression-free-survival-for-patients-with-egfr-mutated-advanced-lung-cancer-in-flaura2-phase-iii-trial-05172023.html