Osimertinib plus chemotherapy extends PFS in EGFR-mutated advanced NSCLC
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Key takeaways:
- Osimertinib plus chemotherapy significantly improved PFS compared with osimertinib alone.
- Grade 3 or higher hematologic adverse events occurred more frequently in the combination group.
Osimertinib plus chemotherapy conferred significantly greater improvement in PFS compared with osimertinib alone in patients with EGFR-mutated advanced non-small cell lung cancer, according to study results.
Findings of the FLAURA2 trial — presented during International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer — additionally showed the combination regimen appeared safe and well-tolerated.
Rationale and methods
Osimertinib (Tagrisso, AstraZeneca) — a third-generation EGFR-tyrosine kinase inhibitor — previously demonstrated targeted inhibition of EGFR mutations.
“The FLAURA2 trial builds on the favorable results observed in the phase 3 FLAURA trial, where osimertinib displayed superiority over comparator EGFR-TKIs,” Pasi A. Jänne, MD, PhD, professor of medicine at Harvard Medical School, and oncologist at Dana-Farber Cancer Institute’s Lowe Center for Thoracic Oncology, said in an IASLC-issued press release.
Researchers randomly assigned 557 individuals with nonsquamous locally advanced or metastatic NSCLC in a 1:1 ratio to receive either to osimertinib 80 mg daily plus cisplatin or carboplatin chemotherapy (n = 279; median age, 61 years; 62% women; 64% Asian) or osimertinib alone (n = 278; median age, 62 years; 61% women; 63% Asian).
Median duration of pemetrexed exposure was 8.3 months and 76% of patients completed four platinum therapy cycles.
Investigator-assessed PFS served as the study’s primary endpoint. Secondary endpoints included OS, objective response rate and safety.
Findings
Results showed the combination significantly improved median PFS vs. osimertinib alone (HR = 0.62; 95% CI, 0.49-0.79), with an 8.8-month improvement in median PFS with the combination regimen. In addition, median PFS determined by blinded independent central review showed a 9.5-month improvement with the combination regimen.
Data also showed an ORR of 83% with the combination regimen compared with 76% with osimertinib alone.
OS data required longer follow-up and lacked maturity at the time of the presentation.
Results of safety analyses showed the combination appeared well tolerated, with manageable adverse events observed. Common grade 3 or higher adverse events included hematologic events in 64% of patients assigned the combination regimen vs. 27% among those assigned osimertinib alone. Adverse events that led to treatment discontinuation occurred in 11% of the combination group vs. 6% of the monotherapy group.
Implications
“These findings mark a significant advancement in the management of advanced EGFR-mutated NSCLC,” Jänne said in the release. “The FLAURA2 study supports osimertinib combined with platinum-pemetrexed chemotherapy as a new and promising first-line treatment option, poised to make a profound impact on patient outcomes in this challenging disease setting.”
References:
- FLAURA2 results demonstrate osimertinib plus chemotherapy superior compared to osimertinib alone (press release). Available at: https://www.iaslc.org/iaslc-news/press-release/flaura2-results-demonstrate-osimertinib-plus-chemotherapy-superior. Published Sept. 10, 2023. Accessed Sept. 14, 2023.
- Jänne PA, et al. Abstract PL03.13. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer; Sept. 9-12, 2023; Singapore.
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Jänne PA, et al. Abstract PL03.13. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer; Sept. 9-12, 2023; Singapore.
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