Almonertinib Approved in China for EGFR T79M+ NSCLC


The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.

Shun Lu, MD, PhD

Shun Lu, MD, PhD

Shun Lu, MD, PhD

The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation—positive non–small cell lung cancer (NSCLC) who have progressed on or after other EGFR TKI therapy.1

The approval of the third-generation EGFR TKI was based on findings from the open-label phase II APOLLO study, in which treatment with almonertinib led to an objective response rate (ORR) of 68.9% and a disease control rate (DCR) of 93.4% in in patients with recurrent NSCLC harboring EGFR T790M mutations. The median progression-free survival (PFS) was 12.3 months and almonertinib induced an ORR of 61.5% in patients with CNS metastasis.

"Ameile has demonstrated a compelling efficacy and tolerability in NSCLC patients with EGFR mutations," the principal investigator of the APOLLO trial, Shun Lu, MD, PhD, professor of Shanghai Chest Hospital, Affiliated Hospital of Shanghai Jiao Tong University, said in a press release. “Ameile provides a new targeted-therapy option for NSCLC patients with EGFR-mutations, especially for patients with brain metastasis."

In the multicenter, single-arm phase II APOLLO study, 244 patients with recurrent NSCLC harboring EGFR T790M mutations received almonertinib at 110 mg as a once-daily tablet. ORR per blinded independent central review (ICR) was the primary endpoint, with secondary outcome measures including PFS per ICR, DCR, duration of response, and overall survival (OS).

The third-generation EGFR TKI was well tolerated, as drug-related adverse events (AEs) led to treatment discontinuation in fewer than 3% of patients. There were no cases of interstitial lung disease, grade 3 rash, or QT prolongation. The most frequently occurring AEs were grade 1 or 2. Regardless of attribution, the most common AEs were blood creatine phosphokinase increased, rash, pruritus, aspartate aminotransferase increased, and alanine aminotransferase increased.

"Almonertinib serves as a promising option for NSCLC patients, which is supported by the efficacy and safety data from APOLLO as well as other studies," James Chih-Hsin Yang, MD, Phd, Graduate institute of Oncology at National Taiwan University College of Medicine, said in the press release.

Almonertinib is the second third-generation EGFR TKI approved in China for the treatment of patients with metastatic EGFR T790M—positive NSCLC. In September 2019, China’s National Medical Products Administration approved osimertinib (Tagrisso) for the frontline treatment of adult patients with locally-advanced or metastatic NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 (L858R) substitutions.

The approval was based on the phase III FLAURA trial, in which data available at the time showed that frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI therapy—erlotinib (Tarceva) or gefitinib (Iressa). In the double-blind study, the median progression-free survival (PFS) was 10.2 months (95% CI, 9.6-11.1) for standard therapy and 18.9 months (95% CI, 15.2-21.4) with osimertinib (HR, 0.46; 95% CI, 0.37-0.57; P <.0001).2

Data from FLAURA made available subsequent to the approval showed that frontline treatment with osimertinib improved median OS by 6.8 months compared with erlotinib or gefitinib, despite crossover between arms. The median OS in the osimertinib arm was 38.6 months (95% CI, 34.5-41.8) compared with 31.8 months (95% CI, 26.6-36.0) with erlotinib or gefitinib, representing a 20% reduction in the risk of death with the third-generation EGFR inhibitor (HR, 0.799; 95% CI, 0.647-0.997; P = .0462). At the final data cutoff for the study, 54% of patients remained alive at 36 months in the osimertinib arm compared with 44% in the erlotinib/gefitinib group.


  1. Hansoh Pharma's Ameile (Almonertinib) Receives Marketing Authorization in China for Second-Line Treatment for Patients With EGFR T790M-Mutation Non-Small Cell Lung Cancer. Published March 19, 2020. Accessed March 19, 2020.
  2. Ramalingam S, Reungwetwattana T, Chewaskulyong B, et al. Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA. Presented at: 2017 ESMO Congress; Madrid, Spain; September 9-12, 2017. Abstract LBA2_PR.
  3. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Presented at: 2019 ESMO Congress, Barcelona, Spain, September 28 to October 1, 2019. Abstract LBA5_PR.
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