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

Aumolertinib with carboplatin-pemetrexed versus aumolertinib for nonsmall cell lung cancer with EGFR and concomitant tumor suppressor genes (ACROSS2): An open-label, multicenter, randomized phase 3 study. (PubMed, CA Cancer J Clin) - P3 | "Overall survival data were immature (data maturity, 4%). The ACROSS2 trial provides the first prospective evidence supporting a genotype-directed, chemotherapy-targeted intensification approach favoring aumolertinib plus carboplatin-pemetrexed for this molecularly defined population."

Clinical • Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Acquired EGFR L858R mutation following ALK-TKI resistance in lung adenocarcinoma: a case report. (PubMed, Front Oncol) - "We present a patient with Anaplastic lymphoma kinase (ALK) fusion lung adenocarcinoma who received sequential treatment with ALK tyrosine kinase inhibitor (TKI) (crizotinib, PFS:32.3 months and then conteltinib, PFS: 29 months). Subsequently, the patient switched to third generation EGFR-TKI treatment with almonertinib. This case suggests EGFR mutation is one of the mechanisms of ALK-TKI resistance, highlights the value of re-biopsy in identifying potentially targetable resistance mechanisms and underscores the spatiotemporal heterogeneity of tumors under the selective pressure of ALK-TKI."

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

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

First-line Aumolertinib (EGFR tyrosine kinase inhibitor) plus apatinib (VEGFR inhibitor) versus aumolertinib in EGFR-mutant non-small cell lung cancer patients: a randomized, multicenter, phase II trial. (PubMed, Signal Transduct Target Ther) - P3 | "Exploratory analysis revealed that PFS benefits from aumolertinib plus apatinib predominantly in those with TP53 mutations. As an infusion-free option, aumolertinib plus apatinib demonstrated PFS benefits with manageable safety in patients with untreated, EGFR-mutant, advanced NSCLC."

Clinical • Journal • P2 data • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Targeted and immunotherapy based on tissue of origin in carcinoma of unknown primary: a two-case report and literature review. (PubMed, Front Oncol) - "Based on the above results, the patient received chemotherapy with carboplatin and pemetrexed disodium combined with targeted therapy using the EGFR tyrosine kinase inhibitor (TKI) almonertinib mesylate tablets. The two cases reported in this paper demonstrate that targeted and immune treatment plans based on the tissue of origin of the tumor can serve as a clinical option for patients with CUP. These findings may provide new information and references for clinical decision-making in the management of CUP."

IO biomarker • Journal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Disorder • Lung Cancer • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • ALK • EGFR • ROS1

SHR-A2009, a HER3-targeted ADC, plus aumolertinib (A) as 1L or =2L treatment for EGFR-mutated (EGFRm) NSCLC: A phase Ib/II study (ELCC 2026) - P1/2, P3 | "Legal entity responsible for the study Jiangsu Hengrui Pharmaceuticals Co.Ltd. Funding Jiangsu Hengrui Pharmaceuticals Co.Ltd."

ADC • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • ERBB3

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

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

Adjuvant aumolertinib in resected EGFR-mutated stage IA2-IIA NSCLC: Updated long-term outcomes from a multicenter real-world study (ELCC 2026) - "Notably, among patients with stages IB to IIIA disease, the median DFS was 66.1 months—a finding comparable to the reported efficacy of adjuvant osimertinib in similar stage populations. Only one patient (0.5%) experienced a grade ≥3 TRAE.Conclusions This extended real-world analysis confirms that adjuvant aumolertinib provides sustained efficacy, exceptional CNS protection, and a superior safety profile. These findings support its routine clinical use in patients with resected EGFR-mutated NSCLC across stages IA2–IIIA."

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

MRD Evaluation of Adjuvant Aumolertinib in stage IB and IA2-3 EGFR-Mutant NSCLC After Complete Surgical Resection: A Multicenter, Single-arm, Open-lable Study (ELCC 2026) - "Grade ≥3 TRAEs were reported in 12 patients (11.4%), with no new safety signals identified.Conclusions This prospective study provides initial evidence supporting the efficacy and acceptable safety of adjuvant aumolertinib in stage IA2–3 and IB EGFR-mutant NSCLC. Continued follow-up will further elucidate the predictive value of MRD dynamics for long-term outcomes."

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

Aumolertinib for AI-predicted EGFR-mutated pulmonary ground-glass nodules: A single-arm, phase II, CATO-2301 trial (ELCC 2026) - P2 | "No progression occurred during treatment. The therapeutic effect of aumolertinib was also validated in a spontaneous GGN-forming EGFR-mutant lung cancer mouse model.Conclusions As a biopsy-free, AI-driven therapeutic paradigm, aumolertinib demonstrates encouraging efficacy with manageable safety in AI-predicted EGFR-mutated pulmonary GGNs of MPLC."

P2 data • Lung Cancer • EGFR

Adjuvant Therapy for EGFR-Mutant Non-Small Cell Lung Cancer: A Network Meta-Analysis of Phase III Trials (ELCC 2026) - "Among third-generation agents, osimertinib and aumolertinib showed comparable DFS benefit (HR 0.98, 95% CI 0.48-1.99).Regarding safety, aumolertinib was associated with a significantly lower risk of diarrhoea versus icotinib (OR 0.05, 95% CI 0.01-0.22) and a numerically lower risk versus osimertinib (OR 0.63, 95% CI 0.25-1.58). Overall, the different treatment options exhibited distinct safety profiles, reflecting their unique clinical characteristics.Conclusions This NMA confirms the superior adjuvant efficacy of third-generation EGFR TKIs. Osimertinib and aumolertinib exhibit similar efficacy, while aumolertinib presents a more favorable tolerability profile, supporting its consideration as a preferable option in adjuvant therapy."

P3 data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Epidemiological characteristics of EGFR-mutant resected NSCLC patients receiving aumolertinib as adjuvant treatment in China: A cross-sectional analysis of a nationwide dataset (ELCC 2026) - "All patients received adjuvant aumolertinib, and 10.6% had combined radiotherapy/chemotherapy.Conclusions Chinese EGFR-mutant resected NSCLC patients receiving adjuvant aumolertinib are characterized by female predominance, adenocarcinoma, multi-ethnic distribution, high classical EGFR mutations, and low PD-L1 expression. More core epidemiological and clinical characteristics will continue to be disclosed at the conference, providing critical real-world evidence to inform the optimization of precision adjuvant treatment."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-L1

A prospective, multicenter phase II study of ctDNA-guided Individualized therapy with aumolertinib ± chemotherapy in advanced L858R EGFR+ NSCLC (ELCC 2026) - "Patients will receive induction therapy with aumolertinib (110 mg once daily) combined with platinum-based chemotherapy (pemetrexed plus cisplatinum or carboplatin) for 4 to 6 cycles...Patients achieving ctDNA clearance will transition to aumolertinib monotherapy, while those with ctDNA persistent positive will continue with aumolertinib plus oral vinorelbine 40mg three times weekly (Monday-Wednesday-Friday)...EGFR L858R mutation and positive ctDNA are critical clinical indicators of poor prognosis. By ctDNA dynamic monitoring as a potential prognostic biomarker, this study aims to address two clinical questions, the necessity of initial intensive therapy for high-risk patients and the feasibility of transitioning to metronomic chemotherapy regimen during maintenance to balance efficacy and tolerability, and how to dynamically adjust treatment strategies (intensification or de-escalation) based on ctDNA status to achieve precision therapy."

Circulating tumor DNA • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Efficacy and safety of double-dose aumolertinib in advanced EGFR-mutant NSCLC with distinct post–first-line EGFR-TKI progression patterns: A prospective, open-label, multicenter study (ELCC 2026) - "Secondary endpoints include ORR, DCR, OS and safety. The study was initiated in January 2026 and is ongoing."

Clinical • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor

Adaptive maintenance therapy guided by multimodal biomarkers after first-line targeted therapy plus chemotherapy for advanced EGFR-mutant non-small cell lung cancer: A multicenter, randomized controlled phase II study (ELCC 2026) - "We plan to enroll 432 patients with advanced EGFR-mutant non-squamous NSCLC who have achieved stable disease (SD), partial response (PR), or complete response (CR) after 4 cycles of first-line induction therapy with "EGFR-TKIs (e.g., aumolertinib) plus platinum and pemetrexed". The primary endpoint is investigator-assessed progression-free survival (PFS) per RECIST 1.1. Secondary endpoints include overall survival (OS), incidence of grade 3-4 chemotherapy-related adverse events during maintenance, treatment adherence, QoL, and MRD predictive accuracy."

Biomarker • Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

High-dose aumolertinib in EGFR-mutant NSCLC with leptomeningeal metastases: A real-world study focusing on poor prognostic subgroups (ELCC 2026) - P | "Treatment-related adverse events occurred in 13.2% (5/38) of patients, with no unexpected safety signals.Conclusions Aumolertinib demonstrated encouraging antitumor activity and a manageable in this LM population. High-dose approaches could benefit poor-prognosis patients and require prospective validation."

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

HS-10241 combined with aumolertinib in EGFR-TKIs pretreated EGFR-mutant and MET-amplified advanced NSCLC: A phase Ib study (ELCC 2026) - P1 | "The treatment related adverse events (TRAEs) leading to discontinuation were reported in 5.3% of pts. The grade ≥3 TRAEs occurring in ≥15% of pts were gamma-glutamyltransferase increased (15.9%), alanine aminotransferase increased (15.9%) and, aspartate aminotransferase increased (15.2%); the incidence of grade ≥3 oedema peripheral was only 3.0%.Conclusions The combination of HS-10241 and aumolertinib showed a favorable safety profile and promising efficacy in pts with NSCLC harboring EGFR mutation and METamp.Editorial acknowledgement Medical writing support was provided by Liangjie Zhong, an employee of Shanghai Hansoh BioMedical Co., Ltd."

Metastases • P1 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Aumolertinib plus oral etoposide (Lastet) as first-line treatment for EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC): The multicenter, phase II EVOLUTION study (ELCC 2026) - P2 | "No new safety signals were identified compared with the established profiles of each individual drug.Conclusions The all-oral combination of aumolertinib and etoposide demonstrated promising antitumor activity and a manageable safety profile in treatment-naive EGFR-mutated NSCLC. This regimen offers a potential convenient, outpatient-based therapeutic strategy worthy of further validation."

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

Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II-IIIB EGFR-mutated NSCLC. The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting."

Journal • P3 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • EGFR

Aumolertinib combined with targeting ETV4 in the treatment of non-small cell lung cancer. (PubMed, J Thorac Dis) - "In vitro experiments using PC-9 cells included Cell Counting Kit-8 (CCK-8) assays (cell viability), wound healing assays (migration), flow cytometry (apoptosis/cell cycle), RNA sequencing (RNA-seq), public transcriptome datasets (GSE193258, GSE178975) were analyzed to compare ETS variant transcription factor 4 (ETV4) expression across EGFR-TKIs (aumolertinib, osimertinib, and gefitinib). ETV4 knockdown enhanced aumolertinib-induced apoptosis/G2/M arrest in vitro and synergistically suppressed tumor growth in vivo. These findings revealed that ETV4 enhanced the therapeutic efficacy of aumolertinib in vitro and in vivo, indicating that ETV4 is a potential therapeutic co-target, serving as a treatment strategy to prevent the acquired resistance induced by aumolertinib."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ETV4 • TCF4

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

Germ-line exon 21 EGFR V831H mutation in advanced NSCLC resistance to almonertinib: a case report. (PubMed, Front Oncol) - "The rapid progression suggests that this specific germ-line variant may confer inherent TKI resistance, potentially exacerbated by the presence of a concurrent KRAS G12V mutation and drug-drug interactions between almonertinib and antituberculosis medications. It underscores the clinical challenge of germ-line EGFR mutations and emphasizes the need for further research to establish effective therapeutic strategies for such rare genotypes."

Journal • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • EGFR • KRAS

REAL-WORLD EFFICACY OF AUMOLERTINIB IN PATIENTS WITH ADVANCED EGFR T790M-POSITIVE NON-SMALL CELL LUNG CANCER: A MULTICENTRE RETROSPECTIVE COHORT STUDY IN JIANGSU PROVINCE, CHINA (ISPOR 2026) - "Despite the more complex baseline characteristics of patients in the real-world setting, this study supports the effectiveness of aumolertinib in routine clinical practice, which is consistent with the efficacy observed in the clinical trial."

Metastases • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR