Lung Cancer Drug Misses Trial Goal, but Shows Fewer Side Effects

ArriVent BioPharma announced Oct. 6 that its Phase 3 FURVENT trial of the lung cancer drug firmonertinib did not meet its main goal in patients newly diagnosed with advanced non-small cell lung cancer (NSCLC) driven by a specific genetic change called an EGFR exon 20 insertion mutation.

That mutation defines a subtype of NSCLC that has historically had fewer treatment options than other EGFR-mutated lung cancers, according to the company. Patients with this mutation often respond less well to older-generation EGFR-targeted drugs, which is why researchers have been testing newer options like firmonertinib specifically in this group.

The FURVENT trial tested two doses of firmonertinib, a pill taken once daily, against standard platinum-based chemotherapy as a first treatment. The trial's main measure was progression-free survival, or how long patients lived without their cancer growing or spreading, as assessed by an independent group of reviewers who did not know which treatment each patient received.

Patients who received the higher of the two doses tested, 240 milligrams, went a median of 11 months without their disease progressing, compared with 9.5 months for those on chemotherapy. While that is a numerical improvement, the difference was not considered statistically significant, meaning researchers cannot rule out that it occurred by chance. The lower, 160-milligram dose performed worse than the higher dose, with a median progression-free survival of 8.4 months.

One detail that may matter to patients and caregivers weighing treatment side effects: firmonertinib caused fewer serious side effects than chemotherapy. Serious, grade 3 or higher side effects occurred in 26% of patients on the higher dose and 22% of patients on the lower dose, compared with 40% of those who received chemotherapy. The company said no new safety concerns emerged beyond what has been seen in earlier studies of the drug.

ArriVent's stock price fell by more than half after the announcement, reflecting how much investors and analysts had been expecting a bigger benefit. One analyst had anticipated roughly a three-month improvement in progression-free survival over chemotherapy; the trial delivered about half that.

“We are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib,” ArriVent Chief Executive Officer Bing Yao said in the company's announcement, according to a report on the results.

What this means for patients: ArriVent has not said whether it will seek Food and Drug Administration approval for firmonertinib in this specific use, continue developing it only in combination with other drugs, or take another path. For now, firmonertinib is not an approved treatment option for newly diagnosed EGFR exon 20 insertion-positive NSCLC in the United States, and this result does not change the treatments currently available. Patients currently enrolled in the FURVENT trial should talk with their care team about what the results mean for their individual treatment plan and whether any changes are being considered.

Firmonertinib remains in testing for other groups of patients with EGFR-mutated lung cancer. ArriVent is continuing its ALPACCA trial of the drug in a different EGFR mutation subtype, known as PACC mutations, as well as a separate study pairing firmonertinib with another targeted therapy in patients with classic EGFR mutations. Results from those studies could still shape the drug's future, even as this particular trial fell short.

EGFR exon 20 insertion mutations account for a small share of all NSCLC cases, but patients with this mutation type have had limited choices beyond chemotherapy and a small number of approved targeted therapies. Any new trial result in this population, positive or negative, is closely watched by patients, caregivers and physicians looking for additional options.

References

1. ArriVent BioPharma, "ArriVent Announces Program Update From the Phase 3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC," GlobeNewswire, Oct. 6, 2026 — https://www.globenewswire.com/news-release/2026/10/06/3375447/0/en/arrivent-announces-program-update-from-the-phase-3-furvent-trial-of-firmonertinib-in-first-line-egfr-exon-20-insertion-mutant-nsclc.html
2. "ArriVent collapses on disappointing lung cancer data," BioPharma Dive — https://www.biopharmadive.com/news/arrivent-furmonertinib-egfr-lung-cancer-study-results/832220/

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