Reports the efficacy and safety of HS-10241 and aumolertinib in NSCLC, suggesting a promising treatment option.
CEP2; IHC: 50% of tumor cells were MET 3+) were enrolled into 4 cohorts based on the treatment history of 1 st to 3 rd generation (G) EGFR-TKIs.All pts received HS-10241 (300 mg, twice a day) and aumolertinib (110 mg, once a day).The primary endpoint was objective response rate (ORR) by investigator.Results: As of Jul 31 th , 2025, 132 pts were enrolled and received 1 dose of study treatment.Of them, 93.9% was lung adenocarcinoma and 96.2% was at stage IV; 12.1% pts received 1 st /2 nd G TKIs (subgroup 1), 45.5% only received 3 rd G TKIs (subgroup 2) and 37.1% received both 1 st /2 nd G and 3 rd G TKIs (subgroup 3).The median follow-up time was 15.7 months (mo).Of 115 efficacy-evaluable pts with METamp, the confirmed ORR (cORR) and disease control rate (DCR) was 48.7% (95% CI: 39.3, 58.2) and 84.3% (95% CI: 76.4, 90.5), with median duration of response (mDoR) of 11.1 (95%CI: 7.5, 16.7) mo, median progression free survival (mPFS) of 7.4 (95% CI: 5.6, 10.1) mo and median overall survival of 25.4 (95% CI: 18.9, 27.8) mo.Further analysis showed cORR in subgroup 1-3 was 60.0%, 41.8%, and 53.3%, with mPFS of 17.3, 7.3 and 7.4 mo, respectively.The treatment related adverse events (TRAEs) leading to discontinuation were reported in 5.3% of pts.The grade 3 TRAEs occurring in 15% of pts were gamma-glutamyltransferase increased (15.9%), alanine aminotransferase increased (15.9%) and, aspartate aminotransferase increased (15.2%); the incidence of grade 3 oedema peripheral was only 3.0%. Conclusions:The combination of HS-10241 and aumolertinib showed a favorable safety profile and promising efficacy in pts with NSCLC harboring EGFR mutation and METamp.
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Teh et al. (2026) studied this question.
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