Drugs / Firmonertinib
Firmonertinib
also known as
Furmonertinib · AST2818 · alflutinib · Alflutinib Mesylate · Furmonertinib Mesilate · Furmonertinib Mesylate · Aifisha · Alflutinib mesilate · +6 more
Small molecule targets EGFR via inhibition
Trials 77 · started per year
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News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | ArriVent BioPharma, Inc. | Results ArriVent Announces Program Update from the Phase 3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC arrivent.com ↗
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. |
| 2026-03-17 | ArriVent BioPharma, Inc. | Results ArriVent to Present Two Preclinical Posters on the EGFR Inhibitor Firmonertinib and on the Novel dual-target MUC16/NaPi2b Tetravalent ADC ARR-002 at the 2026 AACR Annual Meeting arrivent.com ↗
Unique structural features of firmonertinib enhance binding and activity against EGFR mutant proteins including ex20ins mutant proteins in cell lines and NSCLC animal models |
| 2025-12-08 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Presents Preliminary Phase II Results of Oral PD-L1 Inhibitor ABSK043 Combined with EGFR Inhibitor Firmonertinib for the Treatment of NSCLC at ESMO Asia 2025 abbisko.com ↗
Data showed that the combination demonstrated favorable safety and tolerability. |
| 2025-10-19 | Allist Pharmaceuticals, Inc. | Results 新曙光 | 伏美替尼治疗经治EGFR Exon20Ins突变晚期NSCLC的II期研究积极数据在2025 ESMO大会发布 allist.com.cn ↗
最佳客观缓解率（BOR）为51.4%，由独立评审委员会（IRC）评估的确认客观缓解率（ORR）为 44.3%。 |
| 2025-09-09 | ArriVent BioPharma, Inc. | Results Arrivent Presents the Final Analysis of Firmonertinib Monotherapy Data from Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2025 World Conference on Lung Cancer arrivent.com ↗
16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients |
| 2025-06-24 | Allist Pharmaceuticals, Inc. | Results 新曙光 | 伏美替尼单药治疗 EGFR PACC 突变非小细胞肺癌（NSCLC）全球 Ib 期中期数据公开 allist.com.cn ↗
伏美替尼 240 mg经 BICR 评估的中位无进展生存期为 16 个月，中位随访期为 12.5 个月 |
| 2025-06-23 | ArriVent BioPharma, Inc. | Results ArriVent Announces Positive Interim Firmonertinib Monotherapy Data From Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer and Plans to Advance into a Global Pivotal Study arrivent.com ↗
We are encouraged by the strong progression-free survival and durable systemic responses with long term firmonertinib treatment in frontline patients with EGFR PACC mutant NSCLC. |
| 2025-06-02 | RemeGen Co., Ltd. | Results 2025 ASCO | RemeGen Announces Trial Results of c-Met Targeted ADC for Treatment of Non-small Cell Lung Cancer remegen.com ↗
At the 2025 ASCO Annual Meeting, RemeGen presented data from phase 1b/2 clinical trial of RC108 in combination with furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKI treatment, and the results showed obvious synergistic effect between RC108 and furmonertinib. |
| 2025-04-01 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 2025 ELCC | 安罗替尼联合治疗如何“精准制导”EGFR突变晚期非小细胞肺癌？ cttq.com ↗
研究者基于RECIST v1.1标准评估的ORR为90.9%，DCR为100%，中位缓解深度（DpR）为41.1%。 |
| 2024-09-09 | ArriVent BioPharma, Inc. | Results ArriVent Announces Positive Proof-Of-Concept Global Phase 1b Interim Data for Firmonertinib Monotherapy In First-Line EGFR PACC Mutant Non-Small Cell Lung Cancer At The 2024 World Conference On Lung Cancer arrivent.com ↗
“These compelling dose-dependent interim data are the first to demonstrate robust systemic and CNS anti-tumor activity for firmonertinib in a PACC mutant population,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. |
| 2023-10-30 | ArriVent BioPharma, Inc. | Regulatory ArriVent Receives FDA Breakthrough Therapy Designation for Furmonertinib for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations arrivent.com ↗ |
| 2023-09-10 | ArriVent BioPharma, Inc. | Results Furmonertinib Shows Encouraging Efficacy in EGFR Exon20Ins Mut+ NSCLC arrivent.com ↗
According to Baohui Han, MD, PhD, the confirmed objective response rate was 78.6% for treatment-naïve patients with non–small cell lung cancer with EGFR Exon20 insertion mutations treated with furmonertinib 240 mg daily in the FAVOUR trial. |
| 2023-09-10 | ArriVent BioPharma, Inc. | Results Allist and Arrivent Announce interim Results from Ongoing Phase 1b Trial with Furmonertinib at the 2023 World Conference on Lung Cancer arrivent.com ↗
The median duration of response were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve 240 mg, previously treated 240 mg, and previously treated 160 mg patient groups, respectively. |
| 2022-06-03 | Allist Pharmaceuticals, Inc. | Results 伏美替尼再次荣登《柳叶刀·呼吸医学》 allist.com.cn ↗
独立评审委员会（IRC）评估的伏美替尼组的中位PFS为20.8个月，显著优于吉非替尼组的11.1个月（HR=0.44 [95% CI 0.34-0.58]，P＜0.0001），且在各个亚组中的获益总体一致。 |
| 2021-11-01 | Allist Pharmaceuticals, Inc. | Results 突破 | 艾弗沙®一线治疗晚期NSCLC注册研究取得阳性结果 allist.com.cn ↗
相比接受一代EGFR-TKI吉非替尼（易瑞沙®）治疗的对照组，伏美替尼治疗组显示了具有显著统计学意义和临床意义的PFS获益。 |
All press releases naming this drug 22 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 85 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | firmonertinib | “furmonertinib (firmonertinib) at 2 dose levels” NCT05607550 ↗12“high-dose firmonertinib (240 mg, daily)” NCT06971406 ↗ |
| Known as | Aifisha | “Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000 ↗ |
| Known as | alflutinib | “Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000 ↗ |
| Known as | Alflutinib mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258 ↗ |
| Known as | Alflutinib Mesylate | “Alflutinib Mesylate Tablets (AST2818) in Healthy Male Volunteers” NCT03926182 ↗ |
| Known as | AST-2818 MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258 ↗ |
| Known as | AST2818 | “Furmonertinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both sensitising EGFR and EGFR Thr790Met (T790M)...” PMID 33780662 ↗ Mar 20216“Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000 ↗ “A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo” NCT04853342 ↗ “Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution.” NCT06945705 ↗ “Alflutinib Mesylate (AST2818)” NCT03787992 ↗ |
| Known as | Firmonertinib Mesilate | “Firmonertinib Mesilate Tablets” NCT06956001 ↗ |
| Known as | Firmonertinib Mesilate Tablets | “Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.” NCT07182708 ↗ |
| Known as | firmonertinib mesylate | “receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy” NCT06956001 ↗ |
| Known as | Furmonertinib | “Furmonertinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both sensitising EGFR and EGFR Thr790Met (T790M)...” PMID 33780662 ↗ Mar 202161“The efficacy of Furmonertinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was evaluated once a week during the treatment phase.” NCT06315686 ↗ “All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib).” NCT07637448 ↗ “Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.” NCT04401059 ↗ “Furmonertinib is a novel third-generation EGFR-TKI with excellent efficacy and a favorable safety profile.” NCT07548060 ↗ “Study Drug: Furmonertinib (Shanghai Allist Pharmaceuticals Co.,Ltd.)” NCT06969781 ↗ “RC108 plus Furmonertinib and/or Toripalimab” NCT05821933 ↗ “Furmonertinib: 80 mg per dose, once daily” NCT07458919 ↗ “furmonertinib 160mg once daily” NCT07398599 ↗ |
| Known as | Furmonertinib Mesilate | “The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).” NCT04858958 ↗1“Furmonertinib Mesilate Tablets” NCT06970639 ↗ |
| Known as | Furmonertinib Mesylate | “Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.” NCT04671303 ↗ |
| Known as | Furmonertinib(AST2818) | “Furmonertinib(AST2818)” NCT05987826 ↗ |
| Known as | Ivesa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258 ↗ |
| Action | Inhibit | “Alflutinib (AST2818) is a newly developed third-generation EGFR tyrosine kinase inhibitor selective for EGFR-sensitizing and T790M-resistant mutations.” PMID 32007598 ↗ Jan 2020 |
| Modality | Small molecule | “irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor” PMID 35662408 ↗ Jun 2022 |
| Route | Oral | “patients received alflutinib orally until disease progression, unacceptable toxicity, or subject withdrawal.” PMID 32007598 ↗ Jan 2020 |
| Target | EGFR | “Alflutinib (AST2818) is a newly developed third-generation EGFR tyrosine kinase inhibitor selective for EGFR-sensitizing and T790M-resistant mutations.” PMID 32007598 ↗ Jan 2020 |