Aumolertinib was superior in slowing g in tumors with Ex19del alterations compared to L858R mutations [p=0.0018], and superior to gefitinib in slowing g in tumors with Ex19del alterations [p<0.0001]…

This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer...Among all patients with an EGFR exon 19 deletion mutation, the mPFS for the aumolertinib and gefitinib groups was 20.8 months and 12.3 months, respectively (HR, 0.39; P < .0001)…

Pts with previously untreated metastatic or locally advanced NSCLC and EGFR exon 19 deletion or L858R were randomly assigned in a 1:1 ratio to receive either Au...Au significantly prolonged PFS and DoR compared to G as first-line therapy in pts with advanced NSCLC with EGFRm.

Pts with previously untreated metastatic or locally advanced NSCLC and EGFR exon 19 deletion or L858R were randomly assigned in a 1:1 ratio to receive either Au (110 mg once daily) or G (250 mg once daily)....Au significantly prolonged PFS (median 19.3 vs 9.9 months, HR 0.46, p-value <0.0001). DoR was also significantly prolonged with Au....Au significantly prolonged PFS and DoR compared to G as first-line therapy in pts with advanced NSCLC with EGFRm.

...- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with non-EGFR driver genes mutations assessed by central testing using tumour tissue sample....

...Tumor tissue samples or blood samples diagnosed with stage IB-IIIA NSCLC are confirmed to be rare mutations in EGFR by laboratory tests [including rare mutations such as G719X, L861Q, S768I, and other EGFR site mutations alone or coexisting (except Ex19Del, L858R, T790M) and Ex20Ins) are available]. ...

...Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS; 6....

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...Known EGFR-sensitive mutations (including exon 19 deletion or 21 L858R, both alone or co-existing or accompanied by other EGFR site mutations, with primary T790M mutation can be included, with exon 20 insertion mutation can not be included, blood/cytology/histology approved);...

...EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation)....

...- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with tumor suppressor genes mutations assessed by central testing using tumour tissue sample....

...Tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity-ex19del or L858R-either alone or in combination with other EGFR mutations (eg, G719X, exon 20 insertions, S7681, L861Q) 4....

...The tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations assessed by central testing using tumor tissue sample or blood sample....

...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....

...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....

...Patients with primary non-small cell lung cancer with 2 common EGFR mutations（EGFR 19 Del or 21 L858R）; 6. ...

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...The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M....

...Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib....

...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample....

...- Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations)....

...Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations)....

...NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing....

...- Tumor tissue samples or blood samples were tested and confirmed as EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexisting with other EGFR site mutations)....

...epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutations); 6....

...The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in combination with other EGFR mutations including T790M, assessed by cobas® EGFR Mutation Test (Roche Diagnostics) or Xiamen AmoyDx EGFR (ADx-ARMS, Super-ARMS method) kit in site or central laboratory....

...Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....

...EGFR Exon 19del or Exon 21 L858R mutations; 4....

...Patients must has sensitizing EGFR mutation (e.g....

...Confirmed pathology of EGFR mutation positive（exon 19 deletion, L858R, T790M）NSCLC with brain metastases on enhanced MRI....

...- Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;...

...Cohort A: Patients with EGFR exon 20 insertion, failure of first-line standard chemotherapy, or intolerance to chemotherapy Cohort B: Patients with uncommen EGFR mutations but without exon 19 deletion, L858R, T790M, and exon 20 insertion 3....

...Pathological complete response (pCR)`Major Pathological Response (MPR)`Disease free survival (DFS)`Overall Survival (OS)`R0 resection rate`Downstaging rate`Concordance of EGFRm status between plasma-derived ctDNA`Incidence of Adverse Events (AEs)...

...Tumor tissue samples or blood samples of stage III NSCLC diagnosed as unresectable are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). ...

...The patient had a classical mutation of EGFR (EGFR 19 Del or 21 L858R) in primary non-small cell lung cancer; 6. ...

Eligible patients with EGFR 19del were given Aumolertinib 110mg orally per day for 9 weeks followed by surgery, as one of the six cohorts in the PURPOSE trial….Remarkably, the ORR was 100%. Five patients received VATS lobectomy (83.3%) and one underwent open bi-lobectomy. All patients achieved R0 resection. Importantly, two patients achieved pCR (pCR rate 33.3%) (including one squamous cell carcinoma) and one achieved MPR (MPR rate 50%)....The subcohort analysis from the PURPOSE study has illustrated that Aumolertinib as neoadjuvant therapy is effective and feasible for locally-advanced EGFR 19del NSCLCs.

We are conducting a phase II trial in untreated patients with advanced NSCLC EGFR-sensitizing mutation and performance status of 0 to 2….Patients are treated with aumolertinib 110mg orally perday plus pemetrexed 500mg/m2 and carboplatin...Preliminary overall ORR was 88.2% (30/34)...This is the first report that the combination of aumolertinib and chemotherapy provided a promising therapeutic strategy for advanced EGFR mutation NSCLC patients, even with CNS metastasis. And preliminary data from this trial suggests patients harboring EGFR exon19 deletion mutation and TP53 mutation would benefit more from this combination strategy (Table 1).

In subgroup analysis, for patients with EGFR exon 19 deletion, ORR and DCR were 72.2% and 96.1% respectively, the median DoR was 15.1 months, the median PFS was 12.4 months, the median OS was NR (95% CI: NR-NR). For patients with EGFR L858R mutation, ORR and DCR were 63.5% and 89.4% respectively, the median DoR was 16.5 months, the median PFS was 12.3 months, the median OS was NR (95% CI: 22.9-NR).