First-line combination extends PFS in lung cancer subgroup
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Key takeaways:
- Researchers observed longer PFS with first-line osimertinib-chemotherapy than chemotherapy alone.
- OS data remained immature and will be assessed at a subsequent analysis.
First-line osimertinib plus chemotherapy extended PFS compared with osimertinib alone for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer, topline results of the randomized phase 3 FLAURA2 trial showed.
OS data remained immature and will be assessed at a subsequent analysis, according to the agent’s manufacturer.
EFGR mutations are detected among approximately 10% to 15% of patients with NSCLC in the United States and Europe, and up to 40% of those with NSCLC in Asia, according to an AstraZeneca-issued press release.
Osimertinib (Tagrisso, AstraZeneca) is a third-generation, irreversible EGFR tyrosine kinase inhibitor. It is approved as monotherapy in the United States for first-line treatment of locally advanced or metastatic EGFR mutation-positive NSCLC, as well as locally advanced or metastatic EGFR T790M-mutation-positive NSCLC. It also is approved as adjuvant treatment of early-stage EGFR mutation-positive NSCLC.
The open-label, multicenter FLAURA2 trial — conducted at 150 centers in more than 20 countries — included 586 patients with stage IIIB/IIIC or stage IV EGFR mutation-positive NSCLC.
Researchers randomly assigned them to 80 mg once-daily osimertinib alone or in combination with chemotherapy. Chemotherapy regimens included pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin (area under the curve, 5) every 3 weeks for four cycles, followed by osimertinib with pemetrexed maintenance every 3 weeks.
PFS served as the primary endpoint, with OS as a secondary endpoint.
“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 release. “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 [with] osimertinib alone and as such, can further delay treatment resistance and disease progression.”
Safety outcomes and rates of treatment discontinuation due to adverse events in FLAURA2 appeared consistent with established profiles of osimertinib and the chemotherapy regimens, according to the press release.
Complete data from FLAURA2 will be presented at a medical meeting and shared with global health authorities.
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