ArriVent BioPharma Misses Endpoint in Lung Cancer Trial

ArriVent BioPharma says its Phase 3 FURVENT trial of firmonertinib failed to meet its primary endpoint in previously untreated patients with EGFR exon 20 insertion-mutant non-small cell lung cancer (NSCLC), raising concern about the drug’s development path.

The pivotal trial compared two doses of firmonertinib — 160 mg and 240 mg once daily — against platinum-based chemotherapy plus pemetrexed in patients with previously untreated, locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations. Under blinded independent central review (BICR), median progression-free survival (PFS) was 11.0 months with the 240-mg dose compared with 9.5 months for chemotherapy. The company notes that the difference did not reach statistical significance. The 160-mg dose produced median PFS of 8.4 months.

The company says the results were more favorable under investigator assessment. Median PFS was 11.1 months with firmonertinib 240 mg versus 7.1 months with chemotherapy. Median PFS with the 160-mg dose was 8.3 months.

BICR-confirmed objective response rates were 60% with the 240-mg dose, 35% with 160 mg and 33% with chemotherapy, ArriVent says, adding that overall survival data are not yet mature but showed a trend favoring firmonertinib.

“These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,” ArriVent CEO Bing Yao says. Yao adds that the trial did not demonstrate a “meaningful improvement” in BICR-assessed PFS over chemotherapy and that the company is reviewing the complete dataset as it determines the appropriate development path for firmonertinib.

No new safety signals were identified, according to the company. Grade 3 or higher treatment-emergent adverse events occurred in 52% of patients receiving 240 mg, 53% receiving 160 mg and 55% in the chemotherapy arm.

FDA previously granted firmonertinib a Breakthrough Therapy designation for previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations, as well as Orphan Drug designations for certain EGFR-, HER2- or HER4-mutated NSCLC.