Dr Jänne on Osimertinib Plus Platinum-Based Chemotherapy in EGFR-Mutant NSCLC

Pasi A. Jänne, MD, PhD, director, Lowe Center for Thoracic Oncology, director, Belfer Center for Applied Cancer Science, director, Chen-Huang Center for EGFR Mutant Lung Cancers, senior physician, Dana-Farber Cancer Institute; professor, medicine, Harvard Medical School, discusses findings from the phase 3 FLAURA2 (NCT04035486) trial in patients with EGFR-mutant non–small cell lung cancer (NSCLC).

At the 2023 IASLC World Conference on Lung Cancer, Jänne presented findings from the FLAURA2 trial, which investigated the efficacy and safety of frontline osimertinib (Tagrisso) alone and in combination with platinum-based chemotherapy in patients with NSCLC harboring EGFR mutations. The primary end point of this trial was progression-free survival (PFS), and key secondary end points included overall survival, objective response rate, duration of response, and disease control rate. Patients eligible for enrollment in this trial were those at least 18 years of age with pathologically confirmed, nonsquamous, newly diagnosed locally advanced or metastatic NSCLC. Patients with recurrent NSCLC were also eligible for enrollment if their disease was not fit for curative surgery or radiotherapy.

In FLAURA2, patients who received the osimertinib/chemotherapy combination achieved a statistically significant 8.8-month investigator-assessed PFS improvement compared with those in the osimertinib monotherapy arm, Jänne says. The PFS improvement by blinded independent central review between the combination and monotherapy arms was 9.5 months, according to Jänne.

Regarding safety, the adverse effects (AEs) seen in this trial were those commonly associated with osimertinib and chemotherapy, such as hematologic toxicities, and no new AEs were observed with these agents, Jänne explains. Furthermore, the incidence and severity of interstitial lung disease, which is associated with osimertinib monotherapy, did not increase with the addition of chemotherapy, Jänne says.

The findings from FLAURA2 and other trials may help identify the patients with EGFR-mutant NSCLC who benefit most from the addition of chemotherapy to osimertinib, Jänne emphasizes. Although FLAURA2 shows that osimertinib plus chemotherapy is effective in all patients, some patients are potentially more or less likely to benefit from this therapeutic approach, Jänne notes. Identifying clinical or molecular features that correlate with this benefit will be an important next step for this research, Jänne concludes.