ArriVent BioPharma has reported a miss on the primary endpoint of its pivotal Phase 3 trial. The study enrolled patients with EGFR exon 20 insertion lung cancer. The global FURVENT study tested the oral inhibitor firmonertinib against platinum chemotherapy. All patients had previously untreated, non-squamous non-small cell lung cancer. Neither firmonertinib dose beat chemotherapy on progression-free survival by blinded independent central review. The company issued the result from Newtown Square, Pennsylvania, at 08:00 Eastern on 6 October 2026.
What the FURVENT readout showed
FURVENT enrolled 398 patients at sites including the United States, Europe, Japan and China. ArriVent ran the three-arm study with its partner Allist. Patients received firmonertinib at 160mg daily, firmonertinib at 240mg daily, or platinum-based chemotherapy with pemetrexed. The primary endpoint was progression-free survival by blinded independent central review, using RECIST 1.1. The trial is registered as NCT05607550. The Health Research Authority record for the study planned about 375 participants. Final enrolment ran slightly above that figure.
At the 240mg dose, median progression-free survival reached 11.0 months on blinded review. The chemotherapy arm reached 9.5 months. The hazard ratio was 0.75, with a 95 per cent confidence interval of 0.55 to 1.02. The p value was 0.0654, which did not clear conventional significance. The 160mg arm recorded 8.4 months and a hazard ratio of 0.91.
Blinded review and investigator assessment diverged
The secondary analysis by investigator assessment reads very differently. Median progression-free survival at 240mg was 11.1 months on that measure, barely changed. The chemotherapy arm, however, fell to 7.1 months. The hazard ratio at 240mg was 0.61, with a confidence interval of 0.46 to 0.81.
Almost the whole gap sits in the control arm. The two chemotherapy medians differ by 2.4 months. LSDN reports that discordance as an observation and draws no cause from it. The 6 October release offers no explanation for the difference. Reader discordance is a recognised feature of open-label oncology trials.
Response rates and safety
Confirmed response rates favoured the higher dose on both readings. By blinded review, 60 per cent responded at 240mg against 33 per cent on chemotherapy. By investigator assessment the figures were 61 per cent and 28 per cent. The 160mg arm recorded 35 per cent and 41 per cent respectively.
That response figure sits awkwardly beside the primary result. Nearly twice as many patients responded on firmonertinib at 240mg as on chemotherapy. The higher response rate did not produce a significant progression-free survival gain on blinded review. Response rate and progression-free survival are measuring different things here. ArriVent published no median duration of response in the release.
Grade 3 or higher treatment-emergent adverse events were similar across the three arms. The rates were 52 per cent at 240mg, 53 per cent at 160mg and 55 per cent on chemotherapy. Treatment-related events of grade 3 or higher were lower on firmonertinib. Those rates were 26 per cent, 22 per cent and 40 per cent. ArriVent also observed a trend towards improved overall survival, which it described as not yet mature.
Balance matters here, so the omissions belong alongside the figures. The release carries no central nervous system response data, although brain endpoints were pre-specified secondary measures. It gives no discontinuation rates, no dose reduction figures and no death counts. LSDN found none of those in the 6 October release as at that date.
A second EGFR exon 20 insertion miss in three years
This is not the first oral inhibitor to fall short in this setting. Takeda said in 2023 that it would withdraw Exkivity, or mobocertinib, from the United States market. The FDA had granted that drug accelerated approval on 15 September 2021. The indication covered EGFR exon 20 insertion disease after platinum-based chemotherapy. Approval rested on a 28 per cent objective response rate in a single-arm trial.
Takeda said on 2 October 2023 that its Phase 3 EXCLAIM-2 confirmatory trial did not meet its primary endpoint. EXCLAIM-2 tested mobocertinib in the same first-line setting, also against platinum-based chemotherapy. Takeda then moved to withdraw the drug globally.
One regimen holds FDA approval in first-line EGFR exon 20 insertion disease. The FDA approved amivantamab with carboplatin and pemetrexed on 1 March 2024. The PAPILLON trial returned a hazard ratio of 0.40 on blinded-review progression-free survival. Median progression-free survival was 11.4 months against 6.7 months on chemotherapy alone. That regimen adds an antibody to chemotherapy rather than replacing it.
An oral inhibitor has, however, beaten chemotherapy in this setting. Dizal’s sunvozertinib met its primary endpoint in the Phase 3 WU-KONG28 trial. AstraZeneca licensed the drug from Dizal in July 2026. Dizal reported the full results on 29 May 2026. That study randomised 324 untreated patients with EGFR exon 20 insertion disease. Median progression-free survival by blinded review was 10.3 months against 7.5 months on chemotherapy. The hazard ratio was 0.65. The results were presented at the 2026 ASCO Annual Meeting. They were published simultaneously in the New England Journal of Medicine.
Taiho and Cullinan Therapeutics said on 13 August 2026 that zipalertinib plus chemotherapy met its primary endpoint in REZILIENT3. That Phase 3 trial also enrolled untreated EGFR exon 20 insertion patients. The result came at a planned interim analysis. LSDN found no first-line FDA approval for either drug as at 6 October 2026. These are separate trials, and LSDN draws no cross-trial comparison.
What the result means for UK access
FURVENT was approved to recruit in the UK. The Health Research Authority lists the study as FURMO-004 under IRAS number 1007082. The London Westminster Research Ethics Committee gave a favourable opinion on 10 October 2023, under reference 23/LO/0180. ArriVent BioPharma is named as sponsor on that record. The HRA entry uses the spelling furmonertinib.
The first-line standard in England does not change today. NICE published technology appraisal TA1158 on 28 May 2026. It recommends amivantamab with carboplatin and pemetrexed during a managed access period. The population is untreated adults with activating EGFR exon 20 insertion mutations. The committee agreed that chemotherapy alone was the only appropriate comparator. The same guidance calls these mutations rare in non-small cell lung cancer. It records “around a few hundred cases diagnosed in England and Wales each year”. NICE, NHS England and Johnson & Johnson agreed managed access, with further evidence collected during the period.
What happens next for firmonertinib
Bing Yao, PhD, chairman and chief executive of ArriVent, called the results disappointing. He said the safety profile stayed consistent with previous clinical studies. He added that FURVENT “did not show a meaningful improvement in PFS over chemotherapy by BICR in this study”. The company says it is evaluating the full dataset to determine the most appropriate development path.
The FDA granted firmonertinib breakthrough therapy designation in this first-line indication. It also granted orphan drug designation for non-small cell lung cancer with EGFR, HER2 or HER4 mutations. ArriVent states that the drug is approved in China in three settings. Those include EGFR exon 20 insertion disease after platinum-containing chemotherapy. The 6 October release names no regulatory filing plan.
ArriVent in-licensed firmonertinib from Allist in June 2021. Its latest quarterly filing records a 40.0 million dollar upfront payment plus 1,276,250 common shares. Clinical and regulatory milestones run up to 110.0 million dollars. Commercial milestones run up to 655.0 million dollars. Allist kept development and commercialisation rights across Greater China. LSDN examined a comparable China-origin lung cancer asset when Akeso reported an ivonescimab overall survival win.
A second Phase 3 programme continues. ALPACCA, registered as NCT07185997, tests firmonertinib in first-line lung cancer with EGFR PACC mutations. ArriVent guided in August that FURVENT topline data would arrive in the second half of 2026. The company reported 373.1 million dollars in cash and investments at 30 June 2026. It expected that balance to fund operations into 2028.
Investors marked the shares down hard. stockanalysis.com quoted ArriVent at 15.01 US dollars at 12:41 Eastern on 6 October 2026. That was a fall of 47.26 per cent, for a market capitalisation of 740.11 million dollars. The question now is whether the asset retains a route in uncommon EGFR mutations, where ALPACCA still reads out. LSDN tracks China-origin licensing deals in its China out-licensing deals tracker.
