Bayer's Class 1 Anticancer Drug BAY 2927088 Submitted for Priority Review in China for HER2-Mutant NSCLC
Bayer
Pharmaceutical Product R&D Developer
On March 21, the CDE website showed that Bayer's Class 1 new drug, BAY 2927088 tablets, is proposed to be included in the priority review, with the indication for...Used to treat HER2-positive（ERBB2）Activating MutationAnd have previously received one systemic treatmentAdvanced Non-Small Cell Lung Cancer（NSCLC）Adult PatientsPreviously, the FDA and NMPA had respectively granted BAY 2927088 a Breakthrough Therapy Designation for this indication.
Screenshot source: CDEOfficial Website
NSCLC is the most common type of lung cancer, accounting for more than 85% of lung cancer cases. Activating HER2 mutations are present in 2% to 4% of patients with advanced NSCLC. Current treatment options for patients with HER2-mutant NSCLC includeChemotherapy and ADC，Treatment options are limited. Oral targeted small-molecule therapies hold promise for higher efficacy and safety in patients with HER2-mutant NSCLC.
BAY 2927088 is an orally reversible tyrosine kinase inhibitor.（TKI）, which can effectively inhibit mutant human epidermal growth factor receptor 2（HER2）, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptor（EGFR）, showing high selectivity for mutant EGFR over wild-type EGFR.
In the ongoing Phase I/II SOHO-01 study, researchers evaluated the efficacy and safety of BAY 2927088 as a second-line treatment for patients with advanced NSCLC carrying HER2 activating mutations. Data published in September 2024 showed:
Of the 44 patients enrolled, 43 were evaluable for efficacy.The confirmed objective response rate (ORR) was 72.1%. (n=31；95% CI 56.3, 84.7), including 1 complete remission (2.3%)。
Median Duration of Response (DOR) For 8.7 months (95% CI 4.5-NE) ，Median Progression-Free Survival(PFS) For 7.5 months(95% CI 4.4-12.2)。
In patients with the most common HER2 YVMA insertion mutation,ORR was 90.0%, DoR was 9.7 months, and PFS was 9.9 months.。
The safety of BAY 2927088 is controllable.
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