Ameile (aumolertinib) / Jiangsu Hansoh Pharma, Abdul Latif Jameel Health - LARVOL DELTA

Hansoh Pharma | Ameile’s fourth indication approved for marketing, targeting post-operative adjuvant therapy for EGFR mutation-positive non-small cell lung cancer (Hansoh Pharma Press Release) - "On May 9, 2025, Hansoh Pharmaceutical Group Co., Ltd...announced that a new indication for Ameile (almonertinib mesylate tablets) has been approved for marketing. The new indication is for the adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) mutations, and who have undergone tumor resection. Ameile now has four approved indications in China, maintaining its leading position among domestically developed third-generation EGFR-TKIs. This approval is primarily based on the ARTS study (HS-10296-302), a randomized, double-blind, controlled, multicenter Phase III clinical trial."

China approval • Evidence highlight • Non Small Cell Lung Cancer • EGFR

Phase II Study of BL-B01D1 and Almonertinib for EGFR+ Stage II-IIIB NSCLC (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Effective neoadjuvant aumolertinib therapy facilitates transformation of unresectable to resectable advanced non‑small cell lung: A case report. (PubMed, Oncol Lett) - "The patient received icotinib followed by neoadjuvant aumolertinib, resulting in significant tumor shrinkage and downstaging to meet resectability criteria. The present findings provide novel insights into potential treatment choices for patients with inoperable stage IIIC NSCLC, emphasizing the possibility of achieving PR and undergoing surgery despite drug resistance. However, individual variations in such cases necessitate further research and validation before this approach can be widely implemented."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR

Influences of Magnesium Isoglycyrrhizinate on the Pharmacokinetics of Almonertinib in Rats and Its Potential Mechanisms. (PubMed, Biopharm Drug Dispos) - "There is a drug-drug interaction (DDI) between MgIG and almonertinib, which leads to an increase of systemic exposure for almonertinib. Meanwhile, CYP3A1 and P-gp in the liver may be the primary targets of mediating the DDI, but further clinical trials are needed to confirm these results."

Journal • PK/PD data • Preclinical • Hepatology • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP3A4 • EGFR

AACR 2025 Oral Report | Hansoh Pharmaceuticals' Phase III data on postoperative adjuvant therapy for non-small cell lung cancer is released globally for the first time, with a 2-year disease-free survival rate of 90.2% [Google translation] (Hansoh Pharma Press Release) - P3 | N=192 | ARTS (NCT04687241) | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | "A total of 214 Chinese patients completed randomization (107 in the aumolertinib group and 107 in the placebo group)....The median follow-up time evaluated by BICR was 27.6 months. The median DFS in the aumolertinib group was not reached (95%CI: 29.1-NA), and that in the placebo group was 19.4 months (95%CI:11.2-26.2), with a hazard ratio (HR) of 0.17 (95%CI: 0.09-0.29), P <0.0001. The DFS results assessed by the investigators were consistent with the BICR assessment , with a 2-year DFS rate of 90.2% in the aumolertinib group, significantly better than the 44.4% in the placebo group. OS data are not yet mature (OS event rates in the aumolertinib group/placebo group: 2.8%/3.8%)."

P3 data • Non Small Cell Lung Cancer

Survival of induction aumolertinib followed by aumolertinib and concurrent radiotherapy (RT) in unresectable EGFR-mutated stage III NSCLC: Final analysis of the phase III ADVANCE trial and real-world data. (ASCO 2025) - P3 | "Clinical Trial Registration Number: ChiCTR2000040590 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P3 data • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (EVOLUTION): protocol for a single-arm, phase II clinical trial. (PubMed, BMJ Open) - P2 | "The results of the study will be disseminated through peer-reviewed journals and presentations at academic conferences. NCT06463171."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem) - "This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

APEAK: A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (clinicaltrials.gov) - P1/2 | N=71 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P1/2 trial • Solid Tumor • KRAS

Aumolertinib as adjuvant therapy in patients with stage II-IIIB EGFR-mutated NSCLC after complete tumor resection: A randomized, double-blind, placebo-controlled, phase 3 trial (ARTS) (AACR 2025) - P3 | "Adjuvant aumolertinib demonstrates a statistically significant and clinically meaningful improvement in DFS in patients with stage II-IIIB EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy, when indicated. This DFS benefit underscores the promise of aumolertinib in fulfilling an unmet need for effective adjuvant EGFR-targeted therapy in early-stage NSCLC."

Clinical • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Aumolertinib with or without chemotherapy as first line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations (AENEAS2) (AACR 2025) - P3 | "AENEAS2 (NCT04923906) is a randomized, open-label, multicenter, phase 3 study assessing the efficacy and safety of aumolertinib plus chemotherapy versus aumolertinib alone as first-line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations. Patients who were naïve to treatment with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned in a 1:1 ratio to receive aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5), versus to receive aumolertinib 110 mg QD monotherapy. Aumolertinib plus chemotherapy as a first-line treatment in advanced EGFR-mutant NSCLC demonstrated a statistically significant and clinically meaningful PFS improvement over aumoletinib monotherapy, with a manageable safety profile."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Bayesian network meta-analysis of EGFR-tyrosine kinase inhibitor treatments in patients with EGFR mutation-positive non-small cell lung cancer. (PubMed, Cancer Pathog Ther) - "We conducted a network meta-analysis of randomized controlled trials comparing osimertinib, lazertinib, aumolertinib, befotertinib, furmonertinib, dacomitinib, afatinib, erlotinib, gefitinib, icotinib, and chemotherapy. Osimertinib is the first choice of treatment with considerable efficacy and safety for EGFR mutation-positive NSCLC. The treatments associated with the best PFS in patients with exon 19 deletions and Leu858Arg mutations were furmonertinib and lazertinib, respectively."

Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

2025 CSCO NSCLC Guidelines Major Update, Innovative Drug Ameile Adds Level I Recommendation [Google translation] (Hansoh Pharma Press Release) - "Recently, the '2025 CSCO Diagnosis and Treatment Guidelines Conference' co-organized by the Chinese Society of Clinical Oncology (CSCO) and the Beijing Xisike Clinical Oncology Research Foundation was held in Jinan, Shandong. The conference released the 'CSCO Primary Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2025 Edition)', and Hansoh Pharmaceutical's original innovative drug Ameile (Aumolertinib Mesylate Tablets) added a new level I recommendation for consolidation treatment after chemoradiotherapy for patients with EGFR mutation-positive stage III unresectable non-small cell lung cancer (NSCLC), becoming the first Chinese original third-generation EGFR-TKI to receive this recommendation level....This new recommendation is mainly based on the positive results of Ameile in the POLESTAR study."

Clinical guideline • Non Small Cell Lung Cancer

Combination of Aumolertinib, Dabrafenib, and Trametinib for a Patient with Advanced Lung Adenocarcinoma with an Osimertinib-Induced BRAF V600E Mutation: A Case Report. (PubMed, Onco Targets Ther) - "In conclusion, acquired BRAF-V600E mutations may contribute to osimertinib resistance. Aumolertinib plus BRAF inhibitors improves outcomes in patients with EGFR-L858R and acquired BRAF-V600E comutant lung adenocarcinoma in whom osimertinib treatment has failed."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • TP53

A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Comparison and Analysis of the Drug-Resistance Mechanism of Osimertinib- and Almonertinib-Resistant Cell Lines. (PubMed, Anal Cell Pathol (Amst)) - "Additionally, the invasion of cells in the knockdown group was repressed. These findings indicated that almonertinib and osimertinib exhibited distinct resistance mechanisms in vitro, underscoring the need for tailored treatment approaches."

Clinical • Journal • Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IGFBP7

Establishment and Characterization of a Brain Parenchymal Metastatic Cell Line AlmoR1 Derived From an NSCLC Patient With EGFR-TKI Resistance. (PubMed, Cancer Med) - "These data suggest that the established cell line, AlmoR1, preserved the resistance to broad third-generation EGFR-TKIs and good tumorigenicity in an intracranial orthotopic model, so that it can serve as a new tool to elucidate the pathogenesis, explore new treatment methods, and conduct the development of new drugs for targeted therapy resistance of brain metastases."

Journal • Preclinical • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Multicenter, Single-Arm, Phase II Study of High-Dose Almonertinib as First-Line Treatment for Patients with EGFR Exon 21 L858R-Mutated Advanced Lung Adenocarcinoma (LUAD) (ChiCTR) - P2 | N=122 | Recruiting | Sponsor: The Affiliated Panyu Central Hospital of Guangzhou Medical University; The Affiliated Panyu Central Hospital of Guangzhou Medical University

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Neoadjuvant Aumolertinib for unresectable stage III EGFR-mutant non-small cell lung cancer: a single-arm phase II trial. (PubMed, Nat Commun) - P2 | "RNA-sequencing based analysis revealed increased infiltration of CD8 + T-cells in post-treatment tumors compared to baseline, particularly in responsive and Ex19-Del mutation tumors. Collectively, neoadjuvant Aumolertinib showed promising efficacy and a surgical conversion rate with a tolerable safety profile for unresecable NSCLCm in stage III, potentially involved in the remodeling of tumor microenvironment."

Journal • P2 data • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • EGFR

Neoadjuvant Aumolertinib for unresectable stage III EGFR-mutant non-small cell lung cancer: a single-arm phase II trial (Nature) - P2 | N=56 | NCT04685070 | "The ORR was 70.6% (95% confidence interval: 58%-84%), meeting the pre-specified primary endpoint. Additionally, twenty-three (45.1%) participants converted into resectable disease and underwent surgery. Among them, R0 resection, MPR and pCR rates were 100%, 21.7%, and 13.0%, respectively. The median EFS and OS were not reached. While, the 1- and 2-year EFS rates were 88.2% and 58.8%, respectively. Fatigue (49.0%), alanine aminotransferase concentration elevation (39.2%), and rash (35.3%) were the most common treatment-related adverse events (TRAEs). Grade 3/4 TRAEs occurred in 5 patients (9.8%), and no grade 5 TRAE was recorded."

P2 data • Non Small Cell Lung Cancer

EGFR-mutant advanced NSCLC patients continuously benefit from aumolertinib as post secone-line treatment (ELCC 2025) - "Aumolertinib showed superior antitumor activity with a manageable safety profile as second-line therapy in EGFR-mutant NSCLC patients. Moreover, both aumolertinib monotherapy of high dose and combined therapy are promising options as post second-line treatments. Patients can continuously benefit from aumolertinib."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Safety and efficacy of aumolertinib treatment in patients with advanced NSCLC harboring 20ins and uncommon EGFR mutations (AIM) (ELCC 2025) - P2, P3 | "In patients with advanced NSCLC harboring 20 ins and uncommon EGFR mutations, high-dose aumolertinib demonstrated a tolerable safety profile and encouraging antitumor activity. High-dose aumolertinib is also currently being evaluated in a phase III clinical trial for patients with uncommon EGFR mutations (NCT04951648)."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

High-dose aumolertinib as first-line treatment in advanced NSCLC patients harboring EGFR 21L858R mutation (AHEAD) (ELCC 2025) - "Our study aims to explore a regime that prolongs EGFR-mutated advanced NSCLC patients as well as guarantees patient safety and compliance. The trial recruitment (ChiCTR2500095661) is ongoing and hopefully initial research data will be presented when the conference is held."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

MRD evaluation of aumolertinib in EGFR mutation-positive stage IB and stage IA2-3 NSCLC after complete surgical resection: A multicenter, single-arm, open-label study (ELCC 2025) - "This prospective study provides preliminary evidence supporting the efficacy of aumolertinib as an adjuvant therapy for stage IA2–3 and IB NSCLC. Long-term follow-up is ongoing to further investigate the relationship between MRD and therapeutic efficacy."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Adjuvant aumolertinib for resected EGFR-mutated stage IA2-IIIA non-small cell lung cancer: Updated results from a multiple-center real-world experience (ELCC 2025) - "These updated results reinforce the robust efficacy of aumolertinib as an adjuvant therapy for NSCLC, following surgery, with an excellent safety profile. Long term follow-up is ongoing to investigate additional survival outcomes."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR