The FDA has accepted and granted priority review to a supplemental New Drug Application for osimertinib in combination with chemotherapy for the treatment of patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC), according to a press release from the manufacturer. The FDA’s decision is expected in the first quart of 2024.
The agency based its decision for an expedited review on the results of the phase 3 FLAURA2 trial, which were presented at the 2023 World Conference on Lung Cancer. The study found, the addition of chemotherapy to osimertinib significantly improved progression-free survival (PFS) for patients with EGFR-mutated advanced NSCLC when compared with osimertinib alone.
“These findings mark a significant advancement in the management of advanced EGFR-mutated NSCLC,” said Pasi A. Jänne, MD, PhD, director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, in a press release from the International Association for the Study of Lung Cancer about the meeting’s presentation.
The third-generation irreversible EGFR-targeted TKI osimertinib has become a standard of care for patients with advanced NSCLC with EGFR mutations, after demonstrating superior survival outcomes in the phase 3 FLAURA trial. However, treatment resistance remains a concern, as well as the applicability of treatment within a heterogeneous disease state.
In the FLAURA2 clinical study, Jänne and colleagues randomly assigned 557 patients with advanced NSCLC and no prior systemic therapy to osimertinib (80 mg daily), either alone or in combination with chemotherapy (pemetrexed-cisplatin or carboplatin for four cycles). Following initial treatment, patients received maintenance osimertinib until disease progression or treatment discontinuation; patients assigned to chemotherapy received maintenance pemetrexed (500 mg/m2 every 3 weeks).
PFS served as the study’s primary endpoint. The researchers observed a median PFS of 25.5 months for patients assigned to osimertinib plus chemotherapy, compared to 16.7 months for patients assigned to osimertinib alone (hazard ratio [HR] = 0.62; 95% CI, 0.49-0.79; P < .0001). Treatment with osimertinib plus chemotherapy also led to superior 1-year PFS (80% vs 66%) and 2-year PFS (57% vs 41%). The objective response rate for patients assigned to osimertinib plus chemotherapy was 83%, compared to 76% for patients assigned to osimertinib monotherapy.
“Results from the study demonstrated a remarkable improvement in PFS with the osimertinib plus chemotherapy approach, showcasing a statistically significant reduction in disease progression risk compared to osimertinib monotherapy,” Jänne concluded. “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.”
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Disclosures: Jänne declared financial ties to drugmakers. FLAURA2 is being supported by AstraZeneca.
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