Hansoh Pharmaceutical's Aumetinib Approved as Breakthrough Therapy, Extending PFS by 8-Fold in Unresectable Stage III NSCLC

On March 10, 2025, Hansoh Pharma announced that its self-developed Class I new drug, Aumolertinib Mesylate Tablets (Ameile), received approval from the National Medical Products Administration (NMPA) for the treatment of patients with unresectable locally advanced (Stage III) non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations and who have not experienced disease progression following platinum-based curative chemoradiotherapy. This approval marks the expansion of Aumolertinib into the treatment of locally advanced non-small cell lung cancer, further solidifying its core position in third-generation EGFR-targeted therapy and providing more treatment options for NSCLC patients in China.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. Patients with locally advanced NSCLC often lose the opportunity for surgical cure at the time of diagnosis, making treatment more challenging. Traditional radiotherapy and chemotherapy have certain therapeutic effects, but the outcomes are often unsatisfactory, with a median progression-free survival of only about six months, highlighting an urgent need for new treatment approaches.

Professor Jinming Yu, academician of the Chinese Academy of Engineering and president of Shandong Cancer Hospital, stated that lung cancer is the malignant tumor with the highest incidence and mortality rate in China. Currently, the standard treatment model for patients with stage III unresectable non-small cell lung cancer in clinical practice typically involves radical chemoradiotherapy followed by sequential immunotherapy consolidation. However, for patients carrying EGFR-sensitive mutations, the benefits brought by existing treatments are extremely limited, and patients urgently need more precise and effective innovative treatment methods.

The approval of Aumolertinib this time is based on the results of a study named POLESTAR. The study results showed that for inoperable EGFR-sensitive mutation Stage III non-small cell lung cancer patients who received radical radiotherapy and chemotherapy, the median PFS of using Aumolertinib as consolidation therapy reached 30.4 months (vs placebo 3.8 months), reducing the risk of disease progression by more than 80%, and the median OS has not been reached yet. This means that compared with traditional regimens, Aumolertinib consolidation therapy will continuously reduce the risk of recurrence and metastasis, significantly extending patient survival to eight times longer! Meanwhile, Aumolertinib consolidation therapy demonstrated a benefit trend across all predefined subgroups, showing significant advantages in benefiting a broad population, including patients with poor physical condition, more advanced stages, or older age.
Professor Yu Jinming stated that, based on the excellent efficacy and safety demonstrated in the POLESTAR study, Aumetinib's new indication is expected to enter clinical guidelines, promoting the development of precision treatment for Stage III unresectable non-small cell lung cancer. Meanwhile, the study focuses on Chinese patients, with all enrolled participants coming from China, making it more aligned with the clinical needs of Chinese patients and offering greater guiding value for clinical treatment.

It is reported that as China's first domestically developed third-generation EGFR-targeted therapeutic drug, since its approval and market launch in 2020, Aumolertinib (Almonertinib) has made significant progress in the treatment of non-small cell lung cancer (NSCLC). The recent approval of this new indication suggests its expansion from first-line and second-line treatments to localized advanced treatment in the NSCLC field, achieving comprehensive coverage across all treatment stages. This demonstrates Aumolertinib’s potential to continuously broaden its application boundaries in lung cancer treatment and provide a more comprehensive solution for clinical practice.