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News
A promising EGFR inhibitor falls short in a key lung cancer study. The phase 3 FURVENT trial found that firmonertinib did not significantly improve progression-free survival compared to standard platinum-based chemotherapy in patients with EGFR exon 20 insertion–mutant non-small cell lung cancer (NSCLC). ArriVent BioPharma's CEO called the results "disappointing."
ArriVent BioPharma's firmonertinib — an oral, brain-penetrant EGFR inhibitor — failed to significantly improve progression-free survival (PFS) over standard chemotherapy as a first-line treatment for patients with EGFR exon 20 insertion–mutant non-small cell lung cancer (NSCLC). The phase 3 FURVENT trial, which enrolled 398 patients across the US, Europe, and Asia, missed its primary endpoint, with a median PFS of 11.0 months for firmonertinib (240 mg) vs. 9.5 months for platinum-pemetrexed chemotherapy — a difference that did not reach statistical significance.
Despite the PFS miss, firmonertinib showed a notably higher confirmed objective response rate (ORR) of 60% vs. 33% for chemotherapy, and investigator-assessed PFS trended in its favor. Overall survival data remain immature, with a trend toward improvement observed. The drug's safety profile was consistent with prior studies, with fewer grade 3+ treatment-related adverse events than chemotherapy.
By the Numbers
Why it matters: EGFR exon 20 insertion mutations are notoriously hard to treat, and patients have limited first-line options. While firmonertinib's PFS miss is a setback, its strong ORR and favorable safety profile suggest it may still have a role — and ongoing trials like ALPACCA could help define its future place in therapy.
