Delving into the Latest Updates on Alflutinib Mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Alflutinib, Firmonertinib, Firmonertinib Mesilate

+ [9]

Target

EGFR L858R x EGFR T790M x EGFR exon 20 x EGFR-Ex19del

Action

inhibitors

Mechanism

EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases

Active Indication

EGFR ex20ins mutation in non-small cell lung cancerEGFR exon 19 Deletions Mutant Non-small Cell Lung CancerEGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer+ [16]

Inactive Indication

Malignant Pleural EffusionMetastatic Non-Squamous Non-Small Cell Lung CarcinomaNon-small cell lung cancer stage IIIA

Originator Organization

Shanghai Allist Pharmaceuticals Co., Ltd.

Active Organization

Arrivent BioPharma, Inc.

Shanghai Allist Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Shanghai Allist Pharmaceuticals Co., Ltd.

Arrivent BioPharma, Inc.

Drug Highest PhaseApproved

First Approval Date

China (03 Mar 2021),

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

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Structure/Sequence

Molecular FormulaC29H35F3N8O5S

InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N

CAS Registry2130958-55-1

This is a prospective, single-arm, multicenter Phase II clinical study. It aims to evaluate the efficacy and safety of Firmonertinib combined with chemotherapy in patients with unresectable Stage III lung adenocarcinoma harboring EGFR PACC mutations. Participants will receive Firmonertinib combined with standard chemotherapy. The primary objective is to assess the objective response rate (ORR). This study will provide important evidence for a potential new treatment option for this specific patient population.

Start Date01 Nov 2026

Sponsor / Collaborator

Hunan Cancer Hospital

NCT07807722

/ Not yet recruitingPhase 2IIT

Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy in Patients With EGFR-mutant Resectable NSCLC : A Prospective, Multicenter, Single Arm, Phase II Exploratory Clinical Study

Exploring the efficacy and safety of firmonertinib combined with anlotinib and platinum-based doublet chemotherapy as neoadjuvant therapy in patients with EGFR-mutant resectable NSCLC

Start Date21 Sep 2026

Sponsor / Collaborator

Hubei Cancer Hospital

NCT07622706

/ RecruitingPhase 2IIT

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma.
The goal of this study was to evaluate the efficacy of firmonertinib neoadjuvant in patients with resectable stage II-IIIB EGFR-mutated non-small cell lung cancer (NSCLC) by major pathologic response (MPR).

Start Date03 Sep 2026

Sponsor / Collaborator-

100 Clinical Results associated with Alflutinib Mesylate

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100 Translational Medicine associated with Alflutinib Mesylate

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100 Patents (Medical) associated with Alflutinib Mesylate

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165

Literatures (Medical) associated with Alflutinib Mesylate

01 Dec 2026·INTERNATIONAL JOURNAL OF CANCER

Reassessing the Incidence and Risk Factors of Radiation Pneumonitis in Treatment‐Naive EGFR ‐Mutant NSCLC With Concurrent Third‐Generation EGFR ‐ TKI and Thoracic Radiotherapy

Article

Author: Zhu, Hui ; Yu, Jinming ; Guo, Zhijun ; Jia, Wenxiao ; Chen, Feihu ; Jing, Xuquan ; Tian, Yaru ; Li, Li ; Zheng, Shuyue

ABSTRACT:

This single‐center retrospective study evaluated radiation pneumonitis (RP) in 209 treatment‐naive EGFR‐mutant non‐small cell lung cancer (NSCLC) patients receiving first‐line third‐generation EGFR tyrosine kinase inhibitors (EGFR‐TKIs) plus thoracic radiotherapy (TRT), with concurrent defined as any overlap of ≥ 1 day between EGFR‐TKI and TRT, at Shandong Cancer Hospital and Institute between January 2019 and September 2024, excluding concurrent chemotherapy and anti‐angiogenic therapy. RP was diagnosed by chest computed tomography (CT), clinical symptoms, and irradiated field concordance, while infectious pneumonia and tumor progression were excluded by laboratory tests and serial imaging. Grade ≥ 2 RP occurred in 43.54% of patients (22.01% grade 2, 21.53% grade 3; no grade 4/5 RP), with osimertinib showing the highest rates of grade ≥ 2 and grade 3 RP, followed by aumolertinib and furmonertinib. For grade ≥ 2 RP, patients receiving aumolertinib or furmonertinib had a lower observed risk than those receiving osimertinib, while ipsilateral lung V5 ≥ 35.93% and gross tumor volume (GTV) ≥ 12.62 mL were independent risk factors. For grade 3 RP, an inverse association between smoking history and RP risk was observed, whereas ipsilateral lung V30 ≥ 24.61% and GTV ≥ 14.56 mL were associated with increased risk. Median progression‐free survival (PFS) was 26.70 months, with no significant difference among the three TKIs. In this cohort, first‐line third‐generation EGFR‐TKI plus TRT was associated with frequent but generally manageable RP. TKI type, ipsilateral lung V5/V30, and GTV were key predictors of RP, although the dosimetric thresholds and drug‐specific differences identified in this cohort require external validation.

03 Oct 2026·JOURNAL OF CHEMOTHERAPY

Furmonertinib activity in NSCLC Harbouring EGFR L858R and ERBB2 S310F co-mutations: a case report with literature review

Review

Author: Liu, Shiyue ; Zhang, Dongdong ; Cao, Runze ; Li, Hong

While targeted therapies have remarkably transformed the landscape of lung adenocarcinoma (LUAD) management, the clinical implications of concurrent mutations in EGFR and ERBB2 remain inadequately understood due to their exceptional rarity in patients. This lack of understanding leads to significant uncertainty regarding therapeutic strategies for individuals with such co-mutations, as neither single-agent EGFR tyrosine kinase inhibitors (TKIs) nor HER2-targeted therapies have demonstrated established efficacy in this specific molecular context. Here, we present a compelling case involving a 61-year-old female patient diagnosed with advanced LUAD, with both EGFR L858R (exon 21) and ERBB2 S310F mutations identified through comprehensive next-generation sequencing (NGS). The patient received a treatment regimen consisting of the third-generation EGFR TKI furmonertinib, combined with localized radiotherapy, which resulted in a marked and significant clinical response. Our findings indicate that furmonertinib may effectively address the therapeutic uncertainties associated with EGFR/ERBB2 co-mutations, presenting a promising clinically actionable strategy while we continue to await the advent of more personalized and tailored treatment solutions.

01 Oct 2026·EUROPEAN JOURNAL OF CANCER

High-dose furmonertinib plus bevacizumab and intrathecal pemetrexed for EGFR-RAD51 fusion-positive lung adenocarcinoma with leptomeningeal metastasis: Insights from serial CSF ctDNA monitoring

Letter

Author: Wang, Qiming ; Chen, Haiyang ; Zhao, Jiuzhou ; Wu, Yufeng ; Zhang, Cuicui

98

News (Medical) associated with Alflutinib Mesylate

02 Nov 2026

·www.biospace.com

Significant stock movers of October: Biohaven climbs, ArriVent dives

iStock, Ruangrit A fresh FDA review for Biohaven’s embattled ataxia drug lifted the biotech’s shares, while a late-stage lung cancer miss battered ArriVent, which failed to rebound even after encouraging early ADC data. A renewed regulatory opening and a clinical setback sent two biotech stocks in opposite directions in October. Biohaven gained ground after the FDA agreed to review its rare disease resubmission, while ArriVent BioPharma plunged after its lead candidate missed in a Phase 3 cancer study, then suffered another selloff despite encouraging early results for a separate asset. Here, BioSpace analyzes these two sizeable stock shifts and the developments driving the activity. This monthly series is not intended to be a comprehensive review of all public biotech movement. Who’s hot: Biohaven (BHVN) The FDA has accepted Biohaven’s twice-rebuffed rare disease drug for review, a regulatory decision that sent the biotech’s stock up at least 25% in late October. It’s been a rocky road for troriluzole, Biohaven’s investigational treatment for spinocerebellar ataxia (SCA), a group of rare diseases that lead to the progressive loss of control over movement. In 2023, the FDA refused to even review Biohaven’s new drug application based on a Phase 3 trial that missed its primary endpoint. More recently, in November 2025—after a three-month delay—the FDA rejected troriluzole, also known as Vyglxia, in SCA. In the complete response letter, the regulator cited concerns “inherent to real-world evidence and external control studies.” At the time, Biohaven’s stock halved and, on the heels of the rebuff, the company launched a sweeping cost-optimization initiative to maximize its resources. But now the FDA has accepted the company’s resubmission for review and assigned a new target action date sometime in the first quarter of 2027, according to an Oct. 22 SEC filing . The agency also plans to hold an advisory committee meeting for the application, with an adcomm date expected to be set “in the near term,” according to the document. “Ultimately, we would expect Biohaven shares to re-rate if there is a clear path to approval here for Vyglxia given a blockbuster orphan disease opportunity across all SCA genotypes,” William Blair analysts wrote Oct. 22. Who’s not: Arrivent BioPharma (AVBP) ArriVent BioPharma’s stock halved after its tyrosine kinase inhibitor (TKI) failed to improve progression-free survival (PFS) rates in a Phase 3 lung cancer trial. The biotech’s stock has yet to recover, falling further even after early “promising” data for a separate asset at this year’s European Society for Medical Oncology (ESMO) meeting in Spain. In the first week of October, Arrivent shared open-label data for its most advanced asset, firmonertinib, an EGFR TKI designed to penetrate the brain. The Allist Pharmaceuticals–partnered candidate demonstrated a median PFS of 11 months in certain non-small cell lung cancer (NSCLC) populations, as compared to 9.5 months for patients on chemotherapy—a finding that wasn’t statistically significant. Truist analysts viewed the miss as largely driven by the stronger-than-expected PFS seen in the control group, up from an expected seven months. The trial results sent ArriVent’s stock plummeting nearly 50% on Oct. 6, from $28.46 to $12.09 at market close. Analysts have turned their focus to a late-stage test of firmonertinib in a different type of lung cancer and the biotech’s antibody-drug conjugate (ADC) pipeline, including ARR-217, an ADC ArriVent is developing alongside Lepu Biopharma for colorectal and gastrointestinal cancers. Early data for the asset were presented as a late-breaker at ESMO last week. The Phase 1 data slice demonstrated a 44.8% preliminary objective response rate among patients with metastatic colorectal cancer (mCRC). While Truist found the early findings “encouraging,” displaying “emerging durability, with favorable tolerability,” it didn’t stop investors from sending the biotech’s stock down about 27% that day. Truist deemed the stock drop “disproportionate” and “disconnected” to the ARR-217 data. “We believe today’s weakness instead reflects plausible profit-taking following the stock’s ~39% recovery from its October 6 close through Friday,” Truist wrote in an Oct. 26 note, while also citing “a high differentiation bar in the crowded mCRC ADC landscape.” ArriVent is expected to share Phase 1b data for the asset in the first half of next year, which will provide clarity on its development path, according to Truist. The analyst modeled peak sales of $850 million for ARR-217 and has started including it in the company’s valuation. “Firmonertinib clarity is expected in 1Q27, but ARR-217 begins to rebalance the story,” the analysts wrote. Business Significant stock movers of September: Viking soars, Longeveron slides Viking Therapeutics rode strong obesity data before a major capital raise, while Longeveron’s mid-stage setback prompted questions about its future. October 5, 2026 · 2 min read · Gabrielle Masson Read more

Clinical ResultPhase 3ADCPhase 1

26 Oct 2026

·www.biospace.com

ArriVent to Present Initial Phase 1 Data for CDH17-targeted ADC ARR-217 in Patients with Gastrointestinal Cancers at the ESMO Congress 2026

First-in-human data for ARR-217 selected as a late-breaking oral presentation ArriVent to host virtual webinar on Monday, October 26, 2026, at 8 am ET to discuss the data from the ARR-217 program NEWTOWN SQUARE, Pa., Oct. 23, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that initial safety and efficacy data from the Phase 1 (NCT07066657) study of CDH17-targeted ADC ARR-217 (MRG007) in patients with gastrointestinal cancers, will be presented in a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 taking place in Madrid, Spain, on October 23-27, 2026. ArriVent plans to host a virtual webinar on October 26, 2026 at 8 am ET to discuss the data and ARR-217 program. To register for the event, click here . Oral Presentation Details Title: First-in-human study of MRG007 (ARR-217), a CDH17-directed exatecan ADC, in patients with locally advanced or metastatic solid tumors Abstract Number: LBA34 Time and Date: Sunday October 25, 2026 from 8:30 – 10:00 AM CEST Session: Rapid Oral Session About ARR-217 ARR-217 (also known as MRG007) is a potentially best-in-class cadherin-17 (CDH17)-targeted antibody-drug conjugate (ADC), utilizing a glycan-linked, exatecan-based payload. CDH17 is a membranous cell adhesion molecule frequently overexpressed in colorectal cancer and several other gastrointestinal cancers, with limited expression in normal intestinal tissue and pancreatic duct, making it an attractive target for ADC therapy. ArriVent obtained exclusive rights to develop and commercialize ARR-217 worldwide outside of Greater China under a collaboration agreement with Lepu Biopharma Co., Ltd. ARR-217 is the lead clinical candidate from ArriVent's growing ADC portfolio. About ArriVent ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, anti-tumor activity and safety of ARR-217, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. Contact: Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com

Phase 1License out/inADC

25 Oct 2026

·www.globenewswire.com

ArriVent Announces Initial Phase 1 Data for CDH17-targeted ADC ARR-217 in Patients with Gastrointestinal Cancers at ESMO Congress 2026

44.8% ORR at 6mg/kg dose in late-line CRC patients ARR-217 was generally well-tolerated ArriVent to host virtual webinar on Monday, October 26, 2026, at 8 am ET to discuss the data from the ARR-217 program NEWTOWN SQUARE, Pa., Oct. 25, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced initial encouraging Phase 1 results for ARR-217, (MRG007), a cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC) developed in partnership with Lepu Biopharma Co., Ltd., in patients with gastrointestinal malignancies. The findings were presented as part of an oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress 2026. "These initial results reinforce our confidence in ARR-217 and in CDH17 as a potential therapeutic target for patients with gastrointestinal cancers who face limited treatment options following prior lines of therapy," said Bing Yao, Ph.D., Chief Executive Officer of ArriVent. "We believe the responses observed in this heavily pretreated patient population, together with a manageable safety profile, provided a strong foundation for advancing ARR-217 into a Phase 1b dose optimization study. As the first ADC from our pipeline to enter clinical development, ARR-217 represents an important milestone for our ADC pipeline, and we look forward to dose optimization data expected in 2027." The ongoing multicenter, open-label Phase 1 study (NCT07066657) conducted in the US and China is evaluating the safety, tolerability, efficacy, and pharmacokinetics of ARR-217 in patients with unresectable, locally advanced, or metastatic solid tumors, with an initial clinical development focus in colorectal, pancreatic, and other gastrointestinal (GI) cancers. As of the August 5, 2026 data cutoff, 123 patients with heavily pretreated GI malignancies were treated across 6 dose levels ranging from 2 mg/kg to 8 mg/kg, including 113 patients with Colorectal Cancer (CRC). Key Highlights for ARR-217 Phase 1 Study Include: Strong Anti-tumor Activity with ARR-217 at Multiple Dose Levels At 6 mg/kg Q3W dose, 44.8% (13/29) objective response rate (ORR) observed in pre-treated CRC patients, including 7 confirmed partial responses, 4 partial responses pending confirmation, and 2 unconfirmed partial responsesAt 6 mg/kg Q3W dose, 93.1% (27/29) disease control rate (DCR) observedAt doses 4 mg/kg Q3W and higher, 34.2% (25/73) ORR observed in CRC patients, including 15 confirmed partial responses, 5 partial responses pending confirmation and 5 unconfirmed partial responsesAt doses 4 mg/kg Q3W and higher, 91.8% DCR observedMajority of the responding patients remained on study treatment as of the August 5, 2026 data cutoff Generally, Well Tolerated Safety Profile The most common treatment-related adverse events were Grade 1/2Across all doses, 30.1% (37/123) patients experienced Grade 3 or higher treatment-related adverse events, including neutropenia (12.2%) and diarrhea (8.9%)At 6.0 mg/kg Q3W dose, Grade 3 or higher TRAE was 20.4% (10/49) including 2.0% diarrhea (1/49)No grade 5 TRAE or ILD observed Dose Optimization and Next StepsARR-217 has advanced into Phase 1b dose optimization at doses of 5 and 6 mg/kg Q3W with further dose optimization data expected in 2027. About ARR-217ARR-217 (also known as MRG007) is a potentially best-in-class cadherin-17 (CDH17)-targeted antibody-drug conjugate (ADC), utilizing a glycan-linked, exatecan-based payload. CDH17 is a membranous cell adhesion molecule frequently overexpressed in colorectal cancer and several other gastrointestinal cancers, with limited expression in normal intestinal tissue and pancreatic duct, making it an attractive target for ADC therapy. ArriVent obtained exclusive rights to develop and commercialize ARR-217 worldwide outside of Greater China under a collaboration agreement with Lepu Biopharma Co., Ltd. ARR-217 is the lead clinical candidate from ArriVent's growing ADC portfolio. About ArriVentArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding, business strategy and plans; the activity safety and tolerability of ARR-217; the expected timing and future results of the ongoing clinical study of ARR-217, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

Phase 1ADCClinical ResultLicense out/in

100 Deals associated with Alflutinib Mesylate

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KEGG	Wiki	ATC	Drug Bank
D12956	-	L01XE L01E	DB16087

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	02 Feb 2026
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	China	Shanghai Allist Pharmaceuticals Co., Ltd.	03 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Greece	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Hong Kong	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Italy	Arrivent BioPharma, Inc.	17 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Malaysia	Arrivent BioPharma, Inc.	17 Dec 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05364073 (FURTHER, ESMO2026)	Phase 1	Non-Small Cell Lung Cancer First line EGFR PACC mutations	44	firmonertinib	gtdpdtwmem(fpdattdwqu) = oihkyafkst iszoznexjb (arequdxovs )	Positive	23 Oct 2026
NCT05364073 (FURTHER, ESMO2026)	Phase 1	Non-Small Cell Lung Cancer First line EGFR PACC mutations	44	firmonertinib (detectable EGFR PACC mutation at baseline)	gtdpdtwmem(krctysisut) = krlilislfd vchjoygimy (ioeyfjlchp ) View more	Positive	23 Oct 2026
ChiCTR2300071395 (ESMO2026)	Phase 2	Metastatic Malignant Neoplasm to the Leptomeninges EGFR mutations	53	Firmonertinib 160mg combined with intrathecal injection pemetrexed (PEM)	gbyvqqxlsf(vwegmzmefk) = gfgmpfdssp jpejmzyyqx (rgetaubxqz, 12.3 - 19.7) View more	Positive	23 Oct 2026
ESMO2026	Phase 2	EGFR Mutation Lung Cancer EGFR mutations	54	Firmonertinib 80 mg once daily	pnbzfoqiga(dcueiqmmho) = rash (n=3), pruritus (n=1), oral ulcer (n=2), and pruritus with decreased white blood cell count (n=1) igggwngqnj (uhpgprkpom ) View more	Positive	23 Oct 2026
NCT05445310 (FAME, ESMO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer Adjuvant EGFR mutations	75	Firmonertinib 80 mg QD	gmvazotklf(eadqylyqle) = nlpculldaw aafsmfdtht (hrbfnjusba ) View more	Positive	23 Oct 2026
ChiCTR2300072027 (ESMO2026)	Phase 2	Non-Small Cell Lung Cancer First line EGFR L858R+	29	Firmonertinib 80 mg QD plus Anlotinib 12 mg QD	jfaerkbteb(adqzthqwhx) = ykozevpmqm defysccvgh (pveslcnqha ) View more	Positive	23 Oct 2026
NCT06643000 (ESMO2026 \| CSCO2026)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	57	Furmonertinib + Furmonertinib + Furmonertinib (EGFR-mutated NSCLC with leptomeningeal metastasis)	wxrnbtcwgk(bzbtwlzith) = perdjbuiar moldnviorh (klpwwrnljc ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Non-Small Cell Lung Cancer First line	74	standard of care based on platinum-based chemotherapy with or without anti-angiogenic/immune inhibitor	izvngldlji(cyjqucwhzh) = txkbhunbyi oyvtkfksge (tggkkahbwl )	Positive	23 Oct 2026
ESMO2026	Not Applicable	Non-Small Cell Lung Cancer First line	74	sunvozertinib or furmonertinib or YK-029a or PLB1004 or combination therapy of JMT101 and osimertinib	izvngldlji(cyjqucwhzh) = egewwnzcjw oyvtkfksge (tggkkahbwl )	Positive	23 Oct 2026
WCLC2026	Phase 2	EGFR Mutation Lung Cancer Adjuvant \| Neoadjuvant EGFR sensitizing mutations (19Del or L858R)	14	Firmonertinib	xbnhfesyls(xhiwufbzyx) = zgvuammigu gkkadwuued (rmbdnbqomx ) View more	Positive	12 Sep 2026
NCT07185997 (ALPACCA, WCLC2026)	Phase 3	First line EGFR PACC mutations	480	Firmonertinib 240 mg daily	irjghsxpry(vnsnphmybe) = nhmldngpgp wshsumbbjq (neauemghem ) View more	Positive	12 Sep 2026
NCT06812871 (WCLC2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR mutated	46	Furmonertinib + Bevacizumab + Pemetrexed	pqxxgbkyob(ikidbplhhm) = wipzqmuvnu vvwtqklfdg (nztkqbvouk, 8.52 - 12.02) View more	Positive	12 Sep 2026