ArriVent Biopharma’s Phase 3 trial of firmonertinib fails primary endpoint

ArriVent Biopharma announced that its Phase 3 FURVENT trial in EGFR exon 20 insertion‑mutant non‑small cell lung cancer did not meet the primary progression‑free survival endpoint. The 240 mg dose showed a median PFS of 11.0 months versus 9.5 months for chemotherapy, with a hazard ratio of 0.75 that was not statistically significant. The company said it will review the full dataset to decide the next development steps. The news triggered a steep drop in AVBP shares.

The failure removes the immediate catalyst for firmonertinib’s regulatory approval and leaves the drug’s future uncertain, which drove a sharp sell‑off in the stock. The company’s next actions will determine whether the program can be salvaged or abandoned.

  • 1The Phase 3 FURVENT trial did not achieve its primary endpoint of progression‑free survival.
  • 2The trial enrolled 398 patients globally.
  • 3The 240 mg dose produced a median PFS of 11.0 months versus 9.5 months for platinum‑based chemotherapy.
  • 4The hazard ratio for the 240 mg dose was 0.75 and was not statistically significant.
  • 5CEO Bing Yao said the results were “not what we hoped for” and the company is evaluating the full dataset.
  • Stock decline reported as 63% in material 1 and 56.7% in material 2.

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