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

Aumolertinib for patients with AI-predicted EGFR-mutated pulmonary ground-glass opacity lesions: a single-arm, phase II trial (ESMO 2025) - No abstract available

Clinical • P2 data • Oncology • EGFR

Aumolertinib Plus Anlotinib in Advanced EGFR-Mutant NSCLC With TP53 Co-Mutation: A Single-Arm, Phase II Study (IASLC-WCLC 2025) - P2 | "Table 1 Baseline Characteristics(n=15) p class="MsoNormal"> Conclusions : This represents the first prospective study evaluating aumolertinib plus anlotinib in NSCLC patients with TP53 co-mutations, demonstrating promising efficacy and favorable safety profile. Enrollment for this trial will continue, and further analyses are warranted."

Metastases • P2 data • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • TP53

NTRK1-fusion as an acquired resistance mechanism in EGFRex19 mutated NSCLC: a case report. (PubMed, Front Pharmacol) - "Prior treatments included the first-line therapy gefitinib (250 mg/day) administered from September 2020 to June 2021, targeting the EGFR 19del mutation, achieving a partial response (PR). The second-line therapy osimertinib (80 mg/day) was administered from July 2021 to January 2022, targeting EGFR 19del and T790M mutations, with a progression-free survival (PFS) of approximately 7 months. The third-line therapy almonertinib, another third-generation EGFR-TKI, was administered from January 2022 to March 2022, but the response was poor, leading to further progression. After identifying NTRK fusion and EGFR amplification, the patient was administered larotrectinib as third-line treatment...This case underscores the importance of ongoing molecular testing and the potential need for combination therapies in managing advanced NSCLC with resistance to multiple targeted treatments. The current treatment with camrelizumab combined with chemotherapy shows promise,..."

Journal • Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Respiratory Diseases • Solid Tumor • NTRK • NTRK1

Neoadjuvant Almonertinib Followed by Chemo-Immunotherapy in II-IIIB EGFR-TKI, Interim Analysis of a Single Arm, Phase II Study (NEOVADE) (IASLC-WCLC 2025) - P2 | "Methods : In this single arm, phase II study (NCT06300424), we tend to enroll 32 patients with untreated II-IIIB NSCLC to receive 110mg of almonertinib, followed by adebrelimab and chemotherapy every 3 weeks for 3 cycles before surgery. Twenty-one patients will finish neoadjuvant therapy and surgery as of July 30, 2025, further updated data will be presented at the Conference. Conclusions : Neoadjuvant almonertinib followed by chemo-immunotherapy maybe a potential efficacious treatment for II-IIIB EGFR-NSCLC."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Efficacy and safety of EGFR-TKI for EGFR-mutated NSCLC: systematic review and network meta-analysis. (PubMed, Int J Clin Exp Pathol) - "This network meta-analysis reveals that in first-line treatment, the third-generation EGFR-TKI Furmonertinib has exceptional advantages in mPFS and safety and is suited for patients with long-term disease control needs. Although second-generation Afatinib has the highest objective remission rate, it also increases the possibility of grade ≥3 AEs. Clinically, personalized programs should be devised based on the patient's mutation type, tolerance, and other factors. More head-to-head trials will be required in the future to validate the findings and optimize treatment techniques."

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

Aumolertinib plus Chemotherapy for NSCLC with EGFR and Concomitant Tumor Suppressor Genes (ACROSS 2): Phase III study (IASLC-WCLC 2025) - P3 | "Patients will be randomized (1:1) to receive aumolertinib once daily 110 mg plus carboplatin (AUC=5) and pemetrexed 500 mg/m2 Q3W or aumolertinib once daily 110 mg until disease progression. This multicenter, open-label, randomized, controlled, phase III study demonstrated that aumolertinib combined with platinum-pemetrexed showed a statistically significant in PFS compared to aumolertinib monotherapy. The safety profile were manageable."

P3 data • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy of Aumolertinib in Patients With Advanced NSCLC for Uncommon EGFR Exon 19 Deletion Mutations (IASLC-WCLC 2025) - "All pts were received aumolertinib (110 mg), and 5 of them were received aumolertinib plus platinum-pemetrexed. Conclusions : This is the first report showed that aumolertinib monotherapy or combined with chemotherapy performed positive efficacy and safety in pts with ex19del L747_P753>S mutation. It is necessary to conduct further exploration for clinical efficacy of aumolertinib in uncommon ex19del mutations in a larger scale."

Clinical • Metastases • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Respiratory Diseases • Solid Tumor • EGFR

Cardiovascular adverse events associated with epidermal growth factor receptor tyrosine kinase inhibitors in EGFR-mutated non-small cell lung cancer: systematic review and network meta-analysis. (PubMed, BMJ) - "In patients with EGFR-mutated NSCLC, first and third generation EGFR tyrosine kinase inhibitors, as well as combination therapies with antiangiogenesis, were associated with increased risks of cardiovascular adverse events. Risks were significantly higher with third generation compared with first generation inhibitors."

Adverse events • Clinical • Journal • Retrospective data • Review • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Aumolertinib Plus Chemotherapy as First - Line for Ps 2 - 3 Advanced NSCLC With EGFR Mutations: A Phase 2 Subgroup Analysis (IASLC-WCLC 2025) - P2 | "Here, we report pre-specified, exploratory subgroup analyses of the efficacy and safety of aumolertinib combined with pemetrexed and carboplatin in the aforementioned PS 2-3 population. The most common grade ≥ 3 treatment-related adverse event was decreased neutrophil count. Conclusions : Aumolertinib plus chemotherapy shows benefits as first-line treatment for patients with PS 2-3 and EGFR-mutant NSCLC, which may be associated with a higher clearance rate of ctDNA."

Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Local MDT Improve the Survival of Leptomeningeal Metastasis in NSCLC With EGFR Mutation From the CLM-Tree Registry (IASLC-WCLC 2025) - P | "Dose escalation of third-generation TKIs was common (79.7%), including Osimertinib 160 mg (56.1%), Almonertinib 165/220 mg (27.6%), and Firmonertinib 160/240 mg (16.3%).Among 120 patients analyzed, median OS from LM diagnosis was 13 months, with a 1-year survival rate of 51.8%. No significant survival difference was observed between non-severe (LM≤4) and severe (LM score >4) ) groups (12 vs. 10 months, P=0.19). Conclusions : L-MDT combined with TKI escalation may improve survival in EGFR-mutant NSCLC patients with LM, especially those with severe neurological symptoms."

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

Real-World Data of Adjuvant Therapy With Aumolertinib for EGFR-Mutated NSCLC Patients (IASLC-WCLC 2025) - "The 3-year OS rate of aumolertinib was 98.3% (2 pts died, one from COVID-19 and the other died in a car accident, both unrelated to lung cancer treatment), compared with 85% for Osimertinib in the ADAURA study. Conclusions : Our real-world study data reinforces the remarkable effectiveness of aumolertinib as a postoperative adjuvant treatment for NSCLC with an excellent safety profile. Although 5-year OS data were not available in this study, the findings suggest that aumolertinib has the potential to improve pts outcomes."

Clinical • Real-world • Real-world evidence • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • TP53

A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer (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

Real-World Clinical Outcomes in Chinese Patients With Advanced EGFR-Mutated NSCLC on First-Line Third-Generation EGFR-TKIs Treatment (IASLC-WCLC 2025) - "Introduction : Aumolertinib and osimertinib are both third-generation (3G), irreversible epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) that were approved for first-line treatment of advanced non-small cell lung cancer (aNSCLC) patients with EGFR mutation (EGFRm). Conclusions : Unlike the phase 3 trials FLAURA (FLAURA-China) and AENEAS, the real-world baseline characteristics of Chinese patients diagnosed with EGFRm aNSCLC were more complex, yet 3G EGFR-TKIs demonstrated a more favourable clinical outcome. The results of this study have provided further insight into the clinical practice of using 3G EGFR TKIs in Chinese patients diagnosed with EGFRm aNSCLC in a real-world setting."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Aumolertinib as Adjuvant Therapy in I-III EGFRm NSCLC : Also Effective in Patients With Multiple Prognostic Risk Factors (IASLC-WCLC 2025) - "Notably, therapeutic efficacy remained robust regardless of comorbidity severity, age, or cumulative risk burden. Continuous follow-up is ongoing to further investigate survival outcomes."

Clinical • Cardiovascular • Diabetes • Fatigue • Hypertension • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I A EGFR Mutated NSCLC With High Risk (APPOINT) (IASLC-WCLC 2025) - P2 | "There were no grade ≥3 AE occurred during aumolertinib treatment group, and no new safety signals were observed. Conclusions : The data demonstrated that compared with the observation group, aumolertinib treatment group exhibited superior efficacy and safety in stage IA EGFR mutated NSCLC pts with high-risk pathological features, highlighting its clinical utility potential for EGFR mutated stage IA NSCLC management."

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

Feasibility of Aumolertinib Followed by SRT in EGFR+ NSCLC Patients With Intracranial Oligo-Progression: A Phase II, Prospective Study (IASLC-WCLC 2025) - P3 | "Conclusions : The combination of SRT and Aumolertinib therapy is an effective and well-tolerated treatment strategy for EGFR-mutant NSCLC patients with intracranial oligo-progression. We are currently conducting a phase III randomized trial (ALMORA STUDY,NCT05800223) based on this phase II clinical study to investigate the optimal timing of intracranial stereotactic radiotherapy (SRT) in the treatment of brain metastases in patients with EGFR-mutant NSCLC during third-generation EGFR-TKI therapy."

Clinical • P2 data • Fatigue • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Aumolertinib for Treatment-Naïve EGFR-Mutant NSCLC Patients With Brain Metastases: Updated Efficacy Data From the ARTISTRY (IASLC-WCLC 2025) - P=N/A | "Conclusions : Aumolertinib showed superior antitumor activity with a manageable safety profile as first-line therapy in EGFR-mutant NSCLC patients with brain metastases, and patients with brain metastases progression still benefit from high dose Aumolertinib. Enrollment for this trial will continue, and further analyses are warranted to determine longer-term outcomes."

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

5-HT regulates resistance to aumolertinib by attenuating ferroptosis in lung adenocarcinoma. (PubMed, EMBO Mol Med) - "Importantly, we showed that elevated 5-HT levels in patient plasma play a potential role in predicting EGFR-TKI resistance. Our data highlight the critical role of 5-HT and ferroptosis in the development of aumolertinib resistance, and propose HTR3 antagonists as a novel combination therapy strategy for LUAD treatment with aumolertinib."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

PELAGOS: Integrating Surgery and Radiotherapy in EGFR-Mutant N3-Stage III NSCLC After Conversion Therapy (IASLC-WCLC 2025) - P2 | "Additionally, the ADAURA trial demonstrated that adjuvant osimertinib effectively reduces the incidence of distant metastasis in stage IB-IIIA NSCLC from 31% to 13% following surgical resection...Patients deemed suitable for surgery will undergo standard lung cancer resection (excluding total pneumonectomy), including removal of the primary tumor and ipsilateral hilar and mediastinal lymph nodes, followed by hypofractionated radiotherapy targeting N3 metastatic lymph nodes concurrent with almonertinib...2025302), and written informed consent was obtained from all participants. This trial is prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2400093459)."

Surgery • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage IA3 EGFRm NSCLC With High Risk Factors (IASLC-WCLC 2025) - "The trial initiated on March, 2025. Now is ongoing."

Clinical • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Aumolertinib Combined With Lomustine as First-Line Treatment for EGFR-Mutant NSCLC Patients With Brain Metastasis (IASLC-WCLC 2025) - "The secondary endpoints comprise of iPFS, iORR, iDCR, OS and safety. Our study is the first trial to evaluate the efficacy and safety of third-generation EGFR-TKI plus traditional oral chemotherapy drug and the "all-oral" regime will be the key to guarantee compliance of patients resulting in lower admission rate and less hospitalization-related infection."

Clinical • Brain Cancer • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

From Targeted Therapy to Targeted Injury: Osimertinib-Associated Gastric Ulcer Bleeding (ACG 2025) - "The patient improved with high-dose pantoprazole, and the follow-up endoscopy showed complete healing. He was transitioned to aumolertinib, which was well tolerated without recurrence. Several factors supported osimertinib as the causative agent: (1) rapid onset of symptoms within one week of starting therapy, (2) resolution of symptoms and mucosal healing upon drug cessation, (3) exclusion of other common causes of ulcer disease, and (4) the known biological mechanism by which EGFR inhibition impairs mucosal integrity and epithelial repair...Prompt recognition, endoscopic evaluation, and cessation of the offending agent are key to preventing severe outcomes. Additional research is needed to characterize the mechanisms and incidence of GI mucosal injury with third-generation EGFR-TKIs.Figure: Figure 1: " Endoscopic view showing gastric bleeding"Figure: Figure 2: " CT scan image showing gastric bleeding""

Anemia • Fatigue • Gastrointestinal Disorder • Infectious Disease • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Peptic Ulcer • Pulmonary Disease • Solid Tumor

Clinical Efficacy and Safety Analysis of Osimertinib Versus Aumolertinib in Real-World Treatment of EGFRm Advanced NSCLC (IASLC-WCLC 2025) - "Conclusions : Presently, aumolertinib is undergoing global development studies to maximize benefits of pts worldwide. This study provides guidance for the future selection of third-generation EGFR-TKIs in countries beyond China."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

First-Line Aumolertinib in EGFR-Mutant Advanced Non-Small Cell Lung Cancer: A Multicenter Real-World Retrospective Study with a Four-Year Follow-Up. (PubMed, Oncol Res) - "Grade 3 and higher AEs were observed at a rate of 4.2%. This study concluded that aumolertinib has considerable safety and efficacy for EGFR-mutant NSCLC in a first-line defense."

Journal • Real-world evidence • Retrospective data • Dermatology • Lung Cancer • Musculoskeletal Diseases • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Pain • Pruritus • Solid Tumor • Squamous Cell Carcinoma • EGFR

Gradually or Locally Progressed NSCLC Patients Benefit From Aumolertinib in Post-1L Dose-Escalation Treatment (IASLC-WCLC 2025) - "Conclusions : High-dose aumolertinib is an optional regimen for patients with advanced NSCLC who develop resistance following initial therapy. It demonstrates promising efficacy and an acceptable safety profile, thus warranting large-scale, multi-center clinical trials to optimize its dosing and patient selection criteria for enhanced clinical utility."

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