Aumolertinib
Aumolertinib is Hansoh's third-generation lung cancer pill, the first China-developed drug of its class, approved for first-line EGFR-mutant lung cancer on the AENEAS trial.
Overview
Approved by the NMPA in March 2020 for EGFR T790M-positive NSCLC after prior EGFR inhibitors and in December 2021 for first-line EGFR-mutant NSCLC on AENEAS (429 patients: median progression-free survival 19.3 versus 9.9 months with gefitinib, hazard ratio 0.46). It has become one of the most prescribed targeted drugs in China after NRDL listing and is under evaluation in Europe. Hansoh is testing it after chemoradiotherapy in stage III disease and in combination regimens.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
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Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2020 | EGFR T790M-positive locally advanced or metastatic NSCLC after EGFR TKI therapy |
| China | 2021 | First-line EGFR exon 19 deletion or L858R NSCLC (AENEAS) |
| EU | 2026 | Aumseqa: first-line advanced NSCLC with EGFR exon 19 deletion or L858R; advanced EGFR T790M-positive NSCLC |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Aumolertinib" OR ABSTRACT:"Aumolertinib" OR TITLE:"Ameile" OR ABSTRACT:"Ameile" OR TITLE:"HS-10296" OR ABSTRACT:"HS-10296" OR TITLE:"almonertinib" OR ABSTRACT:"almonertinib" OR TITLE:"Aumseqa" OR ABSTRACT:"Aumseqa" OR TITLE:"Almonertinib" OR ABSTRACT:"Almonertinib") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Aumolertinib, not a curated reading list.
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