NEWTOWN SQUARE, PA — ArriVent BioPharma Inc. (Nasdaq: AVBP) said its experimental lung cancer drug firmonertinib failed to significantly improve progression-free survival compared with chemotherapy in a pivotal Phase 3 trial, dealing a setback to the company’s efforts to develop a first-line treatment for patients with a difficult-to-treat genetic form of the disease.
The Newtown Square biotechnology company reported that its global FURVENT trial did not meet its primary endpoint of progression-free survival as assessed by blinded independent central review, the principal measure used to evaluate whether the treatment delayed cancer progression or death.
The trial enrolled 398 previously untreated patients with locally advanced or metastatic non-squamous non-small cell lung cancer carrying EGFR exon 20 insertion mutations.
Firmonertinib was evaluated at two oral doses, 160 milligrams and 240 milligrams daily, against platinum-based chemotherapy combined with pemetrexed.
The failure to meet the primary endpoint raises questions about the drug’s development prospects in the first-line treatment setting, despite favorable findings on some secondary measures.
ArriVent reported clinical benefit based on investigator-assessed progression-free survival and independently confirmed objective response rates. The company also observed a preliminary trend toward improved overall survival, although those data remain immature.
The findings from secondary endpoints do not change the trial’s failure to meet its prespecified primary efficacy measure.
“While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study,” said Bing Yao, ArriVent’s chairman and chief executive officer.
The company is reviewing the complete trial dataset before determining the next steps for firmonertinib’s development.
Safety results were generally consistent with earlier clinical studies, with no new safety signals identified.
Grade 3 or higher treatment-emergent adverse events occurred in 52% of patients receiving 240 milligrams of firmonertinib, 53% receiving 160 milligrams and 55% receiving chemotherapy.
Grade 3 or higher treatment-related adverse events were reported in 26% of patients in the higher-dose firmonertinib group, 22% in the lower-dose group and 40% in the chemotherapy group.
Those findings indicate lower rates of severe treatment-related adverse events in both firmonertinib groups than in the chemotherapy control group, although the efficacy results remain the central setback.
The FURVENT trial, conducted with development partner Allist, enrolled patients at sites in the United States, Europe and Asia, including Japan and China.
The study also evaluated overall survival, tumor response and outcomes among patients with brain metastases at baseline.
Firmonertinib is an oral epidermal growth factor receptor inhibitor designed to target several EGFR mutations associated with non-small cell lung cancer.
The drug previously received U.S. Food and Drug Administration Breakthrough Therapy Designation for previously untreated, locally advanced or metastatic non-squamous lung cancer with EGFR exon 20 insertion mutations.
It also received FDA Orphan Drug Designation for non-small cell lung cancer involving EGFR, HER2 or HER4 mutations.
Those designations do not constitute FDA marketing approval.
Firmonertinib is already approved in China for certain forms of EGFR-mutated non-small cell lung cancer, including patients with exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy or who cannot tolerate that treatment.
The company is also evaluating firmonertinib in the Phase 3 ALPACCA trial for previously untreated lung cancer involving EGFR PACC mutations, a separate group of uncommon genetic alterations.
EGFR exon 20 insertion mutations account for approximately 9% of EGFR mutations in non-small cell lung cancer, while PACC mutations account for approximately 12%, according to ArriVent.
Patients with these uncommon mutations have fewer effective treatment options and generally face poorer outcomes with available therapies.
ArriVent’s immediate development decision will center on whether the secondary efficacy findings and emerging survival data provide sufficient support for further investigation of firmonertinib in the exon 20 insertion population following the unsuccessful primary endpoint.
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