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News
A promising lung cancer drug hits a wall. Firmonertinib, an investigational EGFR inhibitor, failed to significantly improve progression-free survival over standard platinum-based chemotherapy in previously untreated patients with EGFR exon 20 insertion–mutant NSCLC in the phase 3 FURVENT trial. The results are a setback for a patient population with few effective treatment options.
A promising lung cancer drug hits a wall
Firmonertinib, an oral, brain-penetrant EGFR tyrosine kinase inhibitor developed by ArriVent BioPharma, has failed to meet the primary endpoint of the phase 3 FURVENT trial. The global, randomized, open-label study enrolled 398 previously untreated patients with locally advanced or metastatic nonsquamous NSCLC harboring EGFR exon 20 insertion mutations — a hard-to-treat subgroup with limited options.
Patients were randomized to firmonertinib at 240 mg, 160 mg, or standard platinum-based chemotherapy (carboplatin or cisplatin plus pemetrexed). Neither dose of firmonertinib significantly improved progression-free survival (PFS) by blinded independent central review compared to chemotherapy, missing the trial's primary endpoint. OS data remain immature, though a trend toward improvement was noted.
By the Numbers
Why it matters: EGFR exon 20 insertion–mutant NSCLC is a rare and aggressive subtype with few approved first-line targeted therapies. This setback leaves a critical treatment gap, and ArriVent says next steps will be determined after a full data review.
