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

Dalmelitinib plus Aumolertinib versus platinum-based chemotherapy in advanced NSCLC patients with MET amplification post EGFR TKI: a randomized, phase 3 study (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Aumolertinib With Stereotactic Radiotherapy at Intracranial Oligo-progression in EGFR-Mutant NSCLC With Brain Metastases: Results of a Prospective Phase II Study (EANO 2026) - "The addition of SRT to ongoing aumolertinib at the time of intracranial oligoprogression is feasible, effective, and well tolerated in EGFR-mutated NSCLC. Notably, in more than half of patients, the initial treatment failure was not primarily related to insufficient control of parenchymal brain metastases."

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

Dynamic clonal evolution of multiple bypass resistance mechanisms in EGFR-mutant lung adenocarcinoma: a case report. (PubMed, Front Oncol) - "Serial sampling and dynamic next-generation sequencing (NGS) revealed a sequential bypass resistance clone evolution trajectory in this patient: initial MET amplification was followed by the detection of a BRAF V600E mutation concurrent with RET fusion, while in the terminal phase, MET amplification re-emerged alongside a progressively increasing TP53 variant allele frequency (VAF).Genotype-guided therapy adjustments yielded an 11-month progression-free survival (PFS) with aumolertinib plus savolitinib, whereas subsequent selpercatinib combined with chemotherapy provided only transient disease stabilization. This case illustrates that EGFR L858R-mutant lung adenocarcinoma can undergo stepwise clonal evolution of multiple bypass resistance mechanisms under aumolertinib selective pressure. Dynamic NGS profiling enables real-time tracking of resistant clone evolution to inform individualized treatment strategies."

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

Hansoh Pharma's Aumseqa EU Marketing Authorization Revoked; Company Cites Procedural Issue, Plans to Reapply (BigGo) - "Hansoh Pharma announced that the European Commission revoked the EU marketing authorization for its lung cancer drug aumolertinib on September 25, after AstraZeneca filed a lawsuit with the General Court of the European Union challenging the approval. The Commission determined that Tagrisso clinical data cited as background reference in Hansoh's application was still within its data protection period at the time of submission, constituting a procedural defect. The company stressed the revocation is unrelated to the drug's quality, safety, or efficacy, and plans to resubmit its application to the EMA based on the original data package as soon as possible."

Corporate lawsuit • EMA filing • European regulatory • Non Small Cell Lung Cancer

Concurrent EGFR exon 19 deletion-insertion and germline BRCA1 alteration in KRAS-wild-type pancreatic ductal adenocarcinoma: A case report and review of therapeutic implications. (PubMed, Oncol Lett) - "The patient developed clinically suspected postoperative recurrence and subsequently achieved durable disease control following individualized exploratory treatment with aumolertinib and olaparib. The present case provides a clinically documented observation of individualized targeted therapy in a rare KRAS wild-type PDAC molecular context and may help inform future hypothesis-driven investigations in selected molecularly defined patients. However, further studies are required to clarify the functional relevance of these molecular alterations and the clinical value of this treatment approach in selected patients with molecularly unique PDAC."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRCA1 • BRCA2 • EGFR • HER-2 • KRAS • TP53

Feasibility of Aumolertinib followed by SRT in EGFR+ NSCLC Patients with Intracranial Oligo-Progression: A Phase II, Prospective Study (ASTRO 2026) - P3 | "Continuing aumolertinib combined with SRT for intracranial oligo-progression is an effective and safe strategy. A phase III trial (ALMORA, NCT05800223) is currently ongoing to further investigate the optimal timing of SRT."

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

Reassessing the Incidence and Risk Factors of Radiation Pneumonitis in Treatment-Naive EGFR-Mutant NSCLC with Concurrent Third-Generation EGFR-TKI and Thoracic Radiotherapy (ASTRO 2026) - "Grade =2 RP incidence by TKI was 54.25% (51/94) for osimertinib, 36.36% (32/88) for aumolertinib, and 29.63% (8/27) for furmonertinib; grade 3 RP rates were 25.53% (24/94), 20.45% (18/88), and 11.11% (3/27), respectively. First-line third-generation EGFR-TKI plus TRT showed no grade 4–5 RP. RP risk was independently associated with TKI selection, ipsilateral lung V5/V30, and GTV. Risk appeared to increase when ipsilateral lung V5 exceeded approximately 35% and when V30 exceeded approximately 25% (data-driven thresholds), together with larger GTV."

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

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=582 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

AUMO-RWE: Real-World Study of Aumolertinib in Patients With Advanced EGFR T790M-Positive NSCLC (clinicaltrials.gov) - P=N/A | N=637 | Completed | Sponsor: Xin Li

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

Health-Related Quality of Life and Cost-Effectiveness of First-Line Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Monotherapy in Advanced EGFR-Mutated Non-small Cell Lung Cancer: A Systematic Review. (PubMed, Cureus) - "Afatinib and aumolertinib were considered cost-effective within the settings examined, whereas osimertinib, dacomitinib, and lazertinib exceeded the willingness-to-pay thresholds used in the respective analyses. In contrast, cost-effectiveness varied markedly across healthcare systems and appeared to be largely driven by drug acquisition costs and country-specific willingness-to-pay thresholds. The principal value distinction among first-line EGFR-TKIs may therefore lie less in global HRQoL and more in whether additional clinical benefit is considered affordable within the local healthcare setting."

HEOR • Journal • Monotherapy • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • 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

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

Neoadjuvant Sacituzumab Tirumotecan Plus Aumolertinib in Resectable EGFR-Mutant NSCLC: A Phase II Trial (IASLC-WCLC 2026) - "The sample size calculation is based on a one-sided α of 0.05 and 80% power, assuming a historical control MPR rate of 25% (NeoADAURA) and an expected MPR rate of 40% in the experimental group. Accounting for a 10% dropout rate, a total of 64 patients will be enrolled."

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

Neoadjuvant EGFR-TKI in Stage I EGFR-Mutant NSCLC: Exploratory Randomized Results From the ANSWER Trial (IASLC-WCLC 2026) - P2 | "Patients were randomized to receive neoadjuvant aumolertinib or erlotinib before surgery. Conclusions : These findings indicate that neoadjuvant EGFR-TKI is feasible in stage I EGFR-mutant NSCLC, including stage IA disease, and may provide encouraging postoperative disease control despite limited pathological regression. As one of the first prospective randomized reports in this setting, this study extends the potential application of neoadjuvant targeted therapy to earlier-stage disease and supports further prospective investigation."

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

Aumolertinib Plus Anlotinib in Advanced NSCLC with Brain Metastasis: A Single-arm, Phase II Study (IASLC-WCLC 2023) - "In addition, EGFR-TKIs combined with bevacizumab can further improve the efficacy, as reported in study JO25567 and NEJ026. Aumolertinib plus anlotinib showed preliminary efficacy as first-line therapy in EGFR-mutant NSCLC patients with brain metastases. The initial subgroup results may demonstrated superior activity of aumolertinib plus anlotinib in patients with multiple intracranial metastases or EGFR 19Del positive. And although with comutations, NSCLC patients with brain metastasis can still benefit from aumolertinib plus anlotinib."

Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCND1 • MET • PIK3CA • TP53

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

To Evaluate the Clinical Effect of Equivalent Dose Hypofractionated Radiotherapy in the Treatmentof Unresectable Stage III NSCLC (IASLC-WCLC 2026) - "All patients completed 2 cycles of concurrent chemoradiotherapy with etoposide and cisplatin...Patients with EGFR gene positive were treated with concurrent chemoradiotherapy followed by osimertinib or almonertinib as consolidation therapy...Conclusions : Hypofractionated equivalent radiotherapy with a single dose of 3Gy can achieve ideal benefit and survival rate in the treatment of unresectable stage III NSCLC, with acceptable toxicity. This mode can provide a treatment option for patients who cannot tolerate conventional fractionated long-term concurrent chemoradiotherapy."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Respiratory Diseases • Solid Tumor • EGFR

Aumolertinib plus chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R: a phase II trial. (PubMed, Oncologist) - P2 | "Aumolertinib plus chemotherapy shows potential as first-line treatment for patients with EGFR-mutant advanced NSCLC, which deserves to be investigated in randomized controlled trials. CtDNA clearance may be a prognostic marker."

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

Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Aumolertinib in combination with chemotherapy significantly improved progression-free survival. Although this regimen was associated with increased toxicity, the side-effects were managed with dose adjustment and supportive treatment aligned with clinical practice. Long-term follow-up is required to assess overall survival. The AENEAS2 study provides evidence to guide clinical practice regarding EGFR-TKIs and their combination use in treating patients with advanced EGFR-mutated NSCLC."

Journal • P3 data • Cardiovascular • CNS Disorders • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

Induction and concurrent aumolertinib with radiotherapy for EGFR-mutated stage III NSCLC: results of phase III ADVANCE trial and real-world validation. (PubMed, Signal Transduct Target Ther) - P=N/A, P3 | "Participants were assigned in a 1:1 ratio to either the experimental arm (110 mg daily aulomertinib plus RT) or the control arm (cisplatin/pemetrexed with RT). These findings were supported by real-world validation (n = 125, median follow-up 32.7 months), in which EGFR tyrosine kinase inhibitors (TKIs) + RT and TKIs+cCRT showed similar outcomes, both superior to cCRT (P < 0.001) (ClinicalTrials.gov: NCT04304638). The ADVANCE trial establishes a novel chemo-free strategy incorporating TKI and RT, which prolongs PFS and demonstrates promising OS in unresectable stage III EGFR-mutant NSCLC versus cCRT."

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

Aumolertinib Maintenance after Chemoradiotherapy in stage III Non-Small-Cell Lung Cancer: Interim Results of the phase III study (POLESTAR) (IASLC-WCLC 2024) - P3 | "Introduction: Consolidation therapy with durvalumab is established as the standard of care (SoC) for patients who do not experience disease progression following concurrent chemoradiotherapy (cCRT). Au demonstrated clinical efficacy by significantly improving PFS versus placebo, without any new safety signal. These findings suggest that Au may represent a novel treatment option as maintenance therapy for patients with unresectable stage III EGFRm NSCLC after the CRT. The study is ongoing for final analysis."

Clinical • IO biomarker • P3 data • P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • EGFR

Organ Preservation Exploratory Clinical Study in Stage II-III Non-Small Cell Lung Cancer (the Future Star) (IASLC-WCLC 2026) - "Cohort A: Almonertinib (110 mg once daily for 18 weeks) combined with pemetrexed and carboplatin (every 3 weeks for up to 4 cycles)...Cohort B: Ensartinib (225 mg once daily for 13 weeks) combined with pemetrexed and carboplatin (every 3 weeks for up to 4 cycles)...Cohort C: Adebrelimab (1200 mg every 3 weeks) combined with chemotherapy (nab-paclitaxel plus carboplatin for squamous histology, or pemetrexed plus carboplatin for non-squamous histology) for up to 3 cycles...The primary endpoint is event-free survival (EFS) assessed by investigators per RECIST v1.1. Secondary endpoints include disease-free survival (DFS), overall survival (OS), quality of life score, organ preservation rate, pathological complete response (pCR) rate and major pathological response (MPR) rate in the surgical arm, and safety."

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

Clinical Characterization and Treatment Responsiveness of Rare EGFR L833V-containing Compound Mutations in Non-Small Cell Lung Cancer: A Multi-Case Series (IASLC-WCLC 2026) - "A locally advanced case (T3N2b) underwent radical chemoradiation followed by maintenance durvalumab, developed metastatic relapse in bone during maintenance treatment...It compares favourably to standard practice by showing that these rare variants remain highly sensitive to 1st-generation (erlotinib) and 3rd-generation (aumolertinib, osimertinib) EGFR TKIs. Conclusions : EGFR L833V compound mutations occurring in cis represent a highly TKI-sensitive molecular subset. This series provides critical real-world evidence supporting the efficacy of multiple TKI generations for this rare population, suggesting they should be managed similarly to common sensitizing mutations."

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

Neoadjuvant almonertinib followed by chemo-immunotherapy in II-IIIb EGFR-mutant NSCLC: A single arm, phase II study (NEOVADE). (ASCO 2026) - P2 | "Patients received almonertinib for 6 weeks, followed by 3 cycles of adebrelimab and chemotherapy before surgery. This study met its primary endpoint, indicating almonertinib followed by chemo-IO was a feasible neoadjuvant treatment in patients with resectable stage IIA-IIIB EGFR-mutant NSCLC, especially in patients with PD-L1 expression. The study was partially supported by Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Co. Ltd."

Clinical • IO biomarker • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-L1

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