SHANGHAI, March 19, 2020 /PRNewswire/ -- Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma"), a leading biopharmaceutical company in China, announced that the National Medical Products Administration (NMPA) has granted marketing authorization for AMEILE (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy.

...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....

...Patients with locally advanced (stage IIIB) or metastatic (stage IV) NON-small cell lung cancer with positive EGFR-resistant mutations who are unable to undergo curative surgery or radiotherapy and whose T790M mutation is confirmed; 2. ...

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

...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....

...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....

...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....

...For the dose expansion and extension cohorts, patients also must have confirmation of tumor T790M+ mutation status from a biopsy sample taken after disease progression on the most recent treatment regimen with an EGFR TKI....

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

...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....

...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....

...this study confirmed the efficacy of aumolertinib for T790M-positive patients with a satisfied safety profile and mPFS up to 16 months in real world.

The present study reports the cases of 3 patients who were challenged with aumolertinib after osimertinib failure. All 3 patients achieved a partial remission. The progression-free survival periods following aumolertinib were 10.0, 11 and 9.0 months (at the time of writing the study)....The present case series suggests the use of aumolertinib challenge as an optional treatment for patients with metastatic NSCLC harboring EGFR-sensitive mutations....EGFR gene mutant status was examined in a peripheral blood sample, revealing an EGFR exon 20-T790M mutation.

The phase II study featured 244 Chinese patients with EGFR T790M mutations and locally advanced or metastatic NSCLC….These patients each received 110 mg of aumolertinib orally, once a day, which resulted in an ORR of 68.9%, a DCR of 93.4%, a median DoR of 15.1 months, a median PFS of 12.4 months, and a median OS of not reached (NR) (95% confidence interval [CI]: 22.9-NR).

Patients with locally advanced or Metastatic non-small cell lung cancer (NSCLC) who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy were enrolled into this registrational phase 2 trial of aumolertinib at 110 mg orally once daily...The ORR by ICR was 68.9% (95% CI: 62.6-74.6). The disease control rate (DCR) was 93.4% (95% CI: 89.6-96.2). The median duration of response (DOR) was 15.1 months (95% CI: 12.5-16.6). The median progression-free survival was12.4 months (95% CI: 9.7-15.0).

Adult pts received aumolertinib 110 mg once daily until disease progression….The median OS was 30.2 mo (95% CI, 24.2-36.4), and the OS rate at 24 mo was 57.5% (95% CI, 50.8-63.6)….Clinical benefit in OS was observed in pts with pretreated EGFR T790M-positive advanced NSCLC receiving aumolertinib.

Almonertinib demonstrated progression-free survival benefit in EGFR T790M positive NSCLC patients who had progressed after previous EGFR-TKI treatment, especially showed clinically meaningful efficacy against CNS metastases, and the safety profile was consistent with that reported previously.

Hansoh Pharmaceutical Group Company Limited announced that the National Medical Products Administration (NMPA) has granted marketing authorization for AMEILE (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy.

In these two cases, progression free survival (PFS) of aumolertinib in primary T790M mutation patients were 22 months and more than 24 months respectively. As we know, this is the first report about aumolertinib monotherapy treatment for primary T790M mutation NSCLC patients, showed a durable disease control and satisfied safety profile, suggested that aumolertinib can be one of the options for primary EGFR T790M mutation.