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

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

A Study of Aumolertinib Combined With Palbociclib in Patients with Advanced Solid Tumors Harboring KRAS Mutations (APEAK) (ESMO Asia 2025) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor • KRAS

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

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) - No abstract available

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

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

Aumolertinib as an effective alternative in osimertinib-intolerant advanced NSCLC with liver cirrhosis: a case report (ESMO Asia 2025) - No abstract available

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

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) - No abstract available

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) - No abstract available

Clinical • 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) - No abstract available

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

Rectal metastasis as the initial presentation of primary lung adenocarcinoma with an EGFR L858R mutation: a case report. (PubMed, World J Surg Oncol) - "Although rectal metastasis harbouring EGFR L858R mutations from primary lung adenocarcinoma is extremely rare, clinicians should have a low threshold for pulmonary low-dose spiral CT. In addition, histopathologic analysis by immunohistochemistry combined with molecular diagnostics is critical for a timely and accurate diagnosis and to distinguish rectal metastases from primary rectal malignancies."

Journal • Colorectal Cancer • Constipation • Cough • Gastroenterology • Gastrointestinal Disorder • Lung Adenocarcinoma • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CDX2 • EGFR • Napsin A • NKX2-1

Clinical study of aumolertinib versus osimertinib in the treatment of EGFR-mutated advanced non-small cell lung cancer. (PubMed, Discov Oncol) - "Aumolertinib and osimertinib exhibit comparable efficacy and safety profiles in the treatment of EGFR-mutant NSCLC, providing a reference path for clinicians to optimize drug treatment strategies in NSCLC."

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

Nutritional status and drug resistance in EGFR-mutant NSCLC: a retrospective cohort study on almonertinib efficacy. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The shortened PFS observed in cachectic patients may reflect accelerated disease progression related to poor nutritional status rather than Almonertinib-specific resistance. Moreover, mild to moderate anxiety was observed in all patients receiving Almonertinib, underscoring the importance of incorporating psychological support in cancer care."

Journal • Retrospective data • Cachexia • Lung Cancer • Mood Disorders • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor • EGFR

Efficacy of Conventional and Novel Tyrosine Kinase Inhibitors for Uncommon EGFR Mutations-An In Vitro Study. (PubMed, Cells) - "The growth inhibitory effects of five novel 3G-TKIs, almonertinib, lazertinib, furmonertinib, rezivertinib, and befotertinib, in addition to currently available TKIs, were evaluated. In conclusion, afatinib exhibited broad activity and some 3G-TKIs showed promising efficacy in the front-line setting. Lazertinib is a potential second-line option after acquisition of resistance to afatinib or osimertinib."

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

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=576 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • 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

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

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

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 Combined With Metronomic Oral Vinorelbine in Advanced EGFR-Mutant NSCLC (IASLC-WCLC 2025) - "Conclusions : Aumolertinib plus metronomic oral vinorelbine has preliminarily shown superior efficacy and the combination therapy is well-tolerated. Enrollment will continue for further analyses."

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