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

Aumolertinib as an effective alternative in osimertinib-intolerant advanced NSCLC with liver cirrhosis: a case report (ESMO Asia 2025) - "This case suggests that aumolertinib may be a viable alternative for patients who are intolerant to osimertinib."

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

First-line aumolertinib 110 mg in non-small cell lung cancer with uncommon EGFR mutations: A prospective real-world study in southwestern China (ESMO Asia 2025) - P=N/A | "In NSCLC patients with uncommon EGFR mutations, especially G719X/S768I, aumolertinib 110 mg showed lower efficacy than 165 mg (reported mPFS of 11.8 months and mOS of 29.4 months),but it had a more favorable safety profile. This supports 110 mg as a practical first-line option for high-risk populations in in resource-limited regions."

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

Prospective study of aumolertinib in NSCLC patients with EGFR sensitive mutations who are intolerant to osimertinib treatment (ESMO Asia 2025) - P2 | "As the first prospective trial in osimertinib-intolerant patients, Aumolertinib demonstrates sustained efficacy and a favorable safety profile with zero discontinuations/deaths, establishing a new paradigm for toxicity-driven treatment strategies."

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

Efficacy and safety of aumolertinib and intrathecal pemetrexed for TKI-failed leptomeningeal metastases from EGFR+ NSCLC: A single-arm, phase II clinical trial (ESMO Asia 2025) - P2 | "This study further showed that aumolertinib and IP is an effective and safe treatment method for the EGFR-TKI-failed NSCLC-LM, and should be recommended for these patients in clinical practice and guidelines."

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

Aumolertinib as adjuvant therapy for elderly patients (≥65 Years) with resected EGFR-mutated non-small cell lung cancer: A multicenter, real-world study (ESMO Asia 2025) - "This real-world study provides the first evidence that adjuvant aumolertinib therapy delivers comparable clinical benefits in both patients aged ≥65 years and those aged <65 years, demonstrating superior efficacy with a manageable safety profile in completely resected stage I-III EGFR-mutant NSCLC."

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

A study of aumolertinib combined with palbociclib in patients with advanced solid tumors harboring KRAS mutations (APEAK) (ESMO Asia 2025) - P1/2 | "Background: Although KRASG12C-specific inhibitors (KRASG12Ci) like sotorasib show efficacy in KRASG12C-mutated NSCLC, therapeutic resistance remains challenging. Clinical Trial Identification. NCT06947811."

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

The CHMP recommended granting a marketing authorisation for Aumseqa (aumolertinib), for the treatment of EGFR-mutated non-small cell lung cancer. (European Medicines Agency)

CHMP • Non Small Cell Lung Cancer

Almonertinib inhibits liver cancer progression by triggering autophagy-dependent ferroptosis through inhibition of the PI3K/Akt1/mTOR pathway. (PubMed, Biochem Pharmacol) - "Interestingly, we demonstrated that Almonertinib-activated autophagy directly participates in ferroptosis activation by promoting Fe2+ release upstream and influencing lipid peroxidation, elucidating the occurrence of autophagy-dependent ferroptosis. In summary, these findings indicate that Almonertinib suppresses liver cancer progression by inducing autophagy-dependent ferroptosis in HepG2 and MHCC-97H cells, potentially providing insights for positioning Almonertinib as a novel therapeutic candidate for future liver cancer treatment."

IO biomarker • Journal • Liver Cancer • Oncology • Solid Tumor • GPX4 • SLC7A11

Third-Generation EGFR-TKIs Combined With Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Real-World Study. (PubMed, Cancer Sci) - "Of these patients, 120, 165, and 97 patients received osimertinib, aumolertinib, and furmonertinib plus chemotherapy as first-line therapy, respectively. Different third-generation EGFR-TKI groups show no statistically significant difference in PFS (HR = 0.75; 95% CI: 0.51-1.10; p = 0.25) after inverse probability of treatment weighting (IPTW), nor in AEs or severe AEs (p = 0.852; p = 0.502). First-line third-generation EGFR-TKI combined with pemetrexed-based chemotherapy demonstrated a favorable ORR and PFS benefit in advanced EGFRm NSCLC."

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

ROS-Mediated Senescence and Autophagy Inhibition Drive 5-FU/Aumolertinib Synergy in Colorectal Cancer. (PubMed, Eur J Pharmacol) - "Although 5-fluorouracil (5-FU) serves as a first-line CRC therapeutic, its clinical utility is constrained by dose-dependent toxicity...Notably, ROS scavenging with N-acetylcysteine reversed these effects. The synergistic tumor growth inhibition was confirmed in HCT116 xenografts using low-dose combination therapy (5-FU 15 mg/kg + AUM 10 mg/kg). Collectively, these findings establish an ROS-dependent autophagic senescence axis as the molecular basis for 5-FU/AUM synergy, offering a novel strategic approach for CRC treatment."

Journal • Colorectal Cancer • Oncology • Solid Tumor

Efficacy and safety with aumolertinib plus anlotinib for untreated EGFR-mutant NSCLC with brain metastases. (PubMed, NPJ Precis Oncol) - P2 | "Aumolertinib plus anlotinib was effective and well-tolerated as first-line therapy in EGFR-mutant NSCLC patients with BMs. Trial Registration: ClinicalTrials.gov(identifier NCT04978753, registered July 20, 2021)."

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

Efficacy of Almonertinib Versus Osimertinib as the First-Line Treatment for Non-Small Cell Lung Cancer With EGFR L858R Mutation and Prognostic Analysis: A Retrospective Comparative Cohort Study. (PubMed, Cancer Med) - "Both almonertinib and osimertinib demonstrated good efficacy in patients with brain metastases, and PD-L1 expression was not associated with the prognosis of EGFR L858R mutant NSCLC. Finally, no significant difference between osimertinib and almonertinib for the treatment of patients with EGFR L858R mutations was observed. Both options remain viable for these patients."

Clinical • IO biomarker • Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

FN-1501 Synergistically Enhances Almonertinib Efficacy in EGFR-TKI-Resistant Lung Adenocarcinoma through Ferroptosis Induction. (PubMed, Anticancer Agents Med Chem) - "FN-1501 exhibits significant antitumor activity and, when combined with Alm, effectively reverses EGFR-TKI resistance by inducing ferroptosis, highlighting its potential for clinical application."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NCOA4

Details Regarding Pneumonitis With High-Dose Aumolertinib-Reply. (PubMed, JAMA Oncol) - No abstract available

Journal • Inflammation • Pneumonia

Details Regarding Pneumonitis With High-Dose Aumolertinib. (PubMed, JAMA Oncol) - No abstract available

Journal • Inflammation • Pneumonia

Case Report: Evolution and targeted therapy of an EGFR-mutant large-cell neuroendocrine carcinoma. (PubMed, Front Oncol) - "The patient exhibited a sustained response to first-line osimertinib, with a progression-free survival of 20 months, followed by transformation to small-cell lung cancer (SCLC) confirmed via histopathological reassessment. Second-line treatment with etoposide and cisplatin combined with radiotherapy resulted in an additional 7 months of disease control...Third-line chemotherapy with paclitaxel, carboplatin, and bevacizumab, followed by maintenance therapy with aumolertinib and anlotinib, extended progression-free survival by 21 months. Overall survival reached 48 months. This case highlights the critical importance of repeated molecular profiling and histologic reevaluation in guiding therapeutic decisions for EGFR-mutant LCNEC undergoing phenotypic evolution."

Journal • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CEACAM5 • EGFR

First-Line Third-Generation EGFR Tyrosine Kinase Inhibitor Monotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, MedComm (2020)) - "Osimertinib (HR, 0.90; 95% CrI, 0.83-0.99) and lazertinib (HR, 0.89; 95% CrI, 0.79-1.00) showed overall survival benefits over first-gen TKIs. Furmonertinib, aumolertinib, and osimertinib had lower rates of severe treatment-related adverse events (TRAEs), while befotertinib exhibited the highest risk of grade ≥3 TRAEs (RR, 3.96; 95% CrI, 2.35-7.17). This study is the first head-to-head comparison of third-gen EGFR-TKIs using a Bayesian network meta-analysis, offering critical insights into efficacy and safety. Our results support personalized selection of third-gen EGFR TKIs for patients with advanced EGFR-mutated NSCLC, particularly for subpopulations with CNS metastases or different mutation subtypes."

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

Real-world study of first-line therapy with aumolertinib for elderly patients with non-small cell lung cancer harboring EGFR mutation. (PubMed, Medicine (Baltimore)) - "The median OS was 33.7 months and 30.7 months in the ≥65 and <65 years groups, respectively (P = .851). Adverse events were not statistically different between the 2 groups.The efficacy and safety profile of aumolertinib as a first-line therapy in elderly patients with epidermal growth factor receptor-mutant NSCLC were similar to those observed in the younger subgroup."

Journal • Observational data • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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

LONG-TERM SURVIVAL AND CLEARANCE OF EGFR-MUTANT CELL-FREE DNA IN METASTATIC EGFR-MUTANT NON-SMALL CELL LUNG CANCER: A CASE SERIES (CHEST 2025) - "She initially received two cycles of pemetrexed/oxaliplatin before transitioning to erlotinib; then switched to osimertinib in 2018 due to adverse effects...She was initially treated with icotinib, which was discontinued in 2019 due to side effects. Brain metastases detected in 2020 led to treatment with almonertinib, followed by osimertinib in 2022... This case series highlights long-term survival with CR in metastatic EGFR-mutant NSCLC treated with osimertinib. CtDNA testing may help determine optimal treatment duration and monitoring, warranting further investigation into when EGFR TKI therapy can be safely discontinued."

Cell-free DNA • Clinical • Metastases • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Resistance to third-generation EGFR-TKIs: Re-challenge or switch to second-generation agents? (ESMO 2025) - "Background This retrospective cohort study evaluated 120 EGFR-mutant NSCLC patients who progressed on third-generation EGFR-TKIs (osimertinib/aumolertinib/furmonertinib), comparing outcomes between those switched to second-generation EGFR-TKIs (3+2 group, n=60) (dacomitinib/afatinib) versus continuing third-generation agents (3+3 group, n=60) (osimertinib/aumolertinib/furmonertinib). Legal entity responsible for the study The authors. Funding Has not received any funding."

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

Integrated machine learning survival framework for consensus modeling in a large multicenter cohort of NSCLC resistant to aumolertinib. (PubMed, Sci Rep) - "Notably, for patients with high ARRPS scores, the addition of CD-437 or TPCA-1 to conventional AUM treatment may help overcome drug resistance. These findings suggest that ARRPS serves as both a prognostic tool and a guide for personalized treatment strategies, potentially optimizing the clinical management of NSCLC patients."

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

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

Clinical • P2 data • Oncology • EGFR

HS-10296 (Almonertinib) enhances radiosensitivity in EGFR-mutant NSCLC (including T790M) through inhibition of EGFR downstream signaling and DNA damage repair. (PubMed, Carcinogenesis) - "These findings establish HS-10296 as a promising radiosensitizer for EGFR-mutant NSCLC through simultaneous targeting of oncogenic signaling via PI3K/AKT and MAPK/ERK pathways and critical DNA repair mechanisms. The study provides compelling preclinical evidence supporting clinical evaluation of HS-10296 combined with radiotherapy for EGFR-driven NSCLC, including tumors with T790M-mediated resistance."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RAD51

Evolution and Targeted Therapy of an EGFR-Mutant Large-Cell Neuroendocrine Carcinoma: A Case Report (Frontiers) - "The patient exhibited a sustained response to first-line osimertinib, with a progression-free survival of 20 months, followed by transformation to small-cell lung cancer (SCLC) confirmed via histopathological reassessment. Second-line treatment with etoposide and cisplatin combined with radiotherapy resulted in an additional 7 months of disease control....Third-line chemotherapy with paclitaxel, carboplatin, and bevacizumab, followed by maintenance therapy with aumolertinib and anlotinib, extended progression-free survival by 21 months."

Clinical data • Large Cell Neuroendocrine Carcinoma • Small Cell Lung Cancer