Ailisi (艾力斯) drug Fumeitini (伏美替尼) misses Phase III lung cancer trial endpoint
In short
Ailisi (艾力斯, 688578.SH) said its drug Fumeitini (伏美替尼), given alone as first-line treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations, did not meet the primary endpoint of the FURVENT Phase III trial: progression-free survival assessed by blinded independent central review. The company said it had spent about 70.82 million yuan on the trial as of September 30, already booked as expenses, with no material impact on current results. Its shares fell by the 20% daily limit on October 8.
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Ailisi (艾力斯, 688578.SH) said its product Fumeitini (伏美替尼) mesylate tablets, used as a single agent in previously untreated patients with locally advanced or metastatic non-squamous non-small cell lung cancer carrying EGFR exon 20 insertion mutations, did not meet the primary endpoint of the FURVENT Phase III trial. The endpoint was progression-free survival assessed by blinded independent central review. The company said it is evaluating the full dataset with ArriVent to determine next steps, Yicai and CLS reported. [ 1 , 2 ]
According to CLS, the company said secondary endpoints, including investigator-assessed progression-free survival and response rate assessed by independent review, showed clinical benefit, and that overall survival data, while immature, showed a trend toward improvement. The safety profile was consistent with earlier studies, with no new signals, the company said. [ 1 ]
As of September 30, 2026, Ailisi had spent about 70.82 million yuan on the pivotal trial. The company said the research costs had been booked in the periods in which they were incurred and would not have a material impact on current results. [ 1 , 2 ]
Huxiu reported that ArriVent published the FURVENT results on October 6. In the high-dose group, tumors shrank in 60% of patients versus 33% in the chemotherapy group, and median progression-free survival was 11 months versus 9.5 months. The p-value for the primary endpoint was 0.0654, above the 0.05 threshold. Huxiu noted that the chemotherapy group's progression-free survival was 9.5 months under independent review but 7.1 months under investigator assessment, and said that using investigator assessment would move the hazard ratio from 0.75 to 0.61. It also said the trial had a sample of about 260 patients, while about 379 progression events would have been needed for 80% power. Huxiu said ArriVent's next trial, ALPACCA, uses response rate and progression-free survival as co-primary endpoints and an approved targeted drug as the comparator. [ 3 ]
On the morning of October 8, Ailisi shares fell by the 20% daily limit, and other innovative drug stocks, including Baipusaisi (百普赛斯), which fell more than 10%, fell with them, CLS and Jiemian reported. CLS said ArriVent's US-listed shares had fallen 47% on October 6 after the news. [ 4 , 5 ]
Why it matters
The result affects Ailisi (艾力斯) and its partner ArriVent, whose US-listed shares fell 47% on October 6, according to CLS, and the selloff spread to other innovative drug stocks in China. Huxiu argued the failure holds lessons for the industry on how trial endpoints are chosen.
Key facts
- The FURVENT Phase III trial of Fumeitini (伏美替尼) as a single agent in first-line EGFR exon 20 insertion-mutant non-small cell lung cancer did not meet its primary endpoint, progression-free survival assessed by blinded independent central review. [ 1 , 2 , 3 ]
- Ailisi (艾力斯) and its partner ArriVent are evaluating the full FURVENT dataset to decide next steps. [ 1 , 2 , 4 ]
- As of September 30, 2026, Ailisi (艾力斯) had spent about 70.82 million yuan on the pivotal trial; the company said the costs were already expensed and would not materially affect current results. [ 1 , 2 ]
- According to CLS, the company said secondary endpoints, including investigator-assessed progression-free survival and response rate assessed by independent review, showed clinical benefit, and that immature overall survival data showed a trend toward improvement. [ 1 ]
- Huxiu reported median progression-free survival of 11 months for the drug group versus 9.5 months for chemotherapy, with a p-value of 0.0654, above the 0.05 significance threshold. [ 3 ]
- Ailisi (艾力斯) shares fell by the 20% daily limit on the morning of October 8, and other innovative drug stocks also fell. [ 4 , 5 ]
- CLS reported that ArriVent's US-listed shares fell 47% on October 6. [ 4 ]
Confirmed by several sources
- The FURVENT Phase III trial of Fumeitini (伏美替尼) did not meet its primary endpoint of progression-free survival assessed by blinded independent central review. [ 1 , 2 , 3 ]
- Ailisi (艾力斯) is evaluating the full dataset with ArriVent to determine next steps. [ 1 , 2 ]
- Ailisi (艾力斯) had spent about 70.82 million yuan on the trial as of September 30, 2026, already expensed and with no material impact on current results, according to the company. [ 1 , 2 ]
- Ailisi (艾力斯) shares fell by the 20% daily limit on October 8. [ 4 , 5 ]
Still unclear
- What Ailisi (艾力斯) and ArriVent will do next with Fumeitini (伏美替尼) in this indication. The company said it is still evaluating the full dataset.
- Whether the drug showed benefit on secondary endpoints and overall survival. Only CLS reports the company's statement on secondary endpoints, and overall survival data are described as immature.
- Whether using investigator assessment would have produced a statistically significant result. This is Huxiu's analysis, which says the hazard ratio would change from 0.75 to 0.61 and the p-value could cross the threshold; no other document makes this claim.
What local media are saying
Timeline, local time
- October 7: CLS reports the announcement by Ailisi (艾力斯) that the FURVENT Phase III trial missed its primary endpoint. [ 1 ]
- October 7: Yicai reports the announcement, including the 70.82 million yuan trial spending. [ 2 ]
- October 8: Huxiu publishes an analysis of the trial results that ArriVent released on October 6. [ 3 ]
- October 8: CLS reports Ailisi shares hit the 20% daily limit down as innovative drug stocks fall. [ 4 ]
- October 8: Jiemian reports the innovative drug sector opened higher then fell, with Ailisi shares at the 20% daily limit down. [ 5 ]