Bayer Submits Prospectus for BAY 2927088, a Novel Oral Reversible TKI Targeting HER2-Mutant Advanced NSCLC

May 13, 2024 00:01 CST Updated 00:01

Bayer

Pharmaceutical Product R&D Developer

BAY2927088 is an orally available, reversible TKI that potently inhibits EGFR driver mutations found in NSCLC and other malignancies.BAY 2927088 works by blocking the activity of EGFR and/or HER2 proteins.

This study is a FiH trial designed to evaluate BAY2927088 in subjects with advanced cancer carrying EGFR and/or HER2 activating mutations. The study focuses on subjects with specific EGFR (ex20ins) driver mutations orTarget population of NSCLC with HER2 activating mutations (including ex20ins), as well as the target NSCLC patient population carrying EGFR driver mutations and secondary mutations that remain active with BAY 2927088 (e.g., C797S). Compared with wild-type EGFR, BAY 2927088 exhibits higher activity against mutant EGFR, suggesting a potentially wider clinical therapeutic window, equivalent to good safety characteristics at effective drug levels. This may advance the use of BAY 2927088 in combination therapies to achieve maximum therapeutic benefit.

Efficacy Data:

2023Efficacy and safety data of BAY2927088 were disclosed at the ESMO conference:In HER2 eXon20ins NSCLC Patients ORR is 60%！

BAY 2927088 demonstrated good safety data, with no deaths reported. Only 26.3% of patients required dose reduction due to side effects. See the specific data in the figure below:

Inclusion and Exclusion Criteria

BAY2927088 Tablets

Suitable人群：Patients with advanced non-small cell lung cancer harboring HER2 gene mutations

Study Drug: BAY2927088 Tablets

Brief Inclusion and Exclusion Criteria:

1. Patients with advanced non-small cell lung cancer who have no standard effective treatment options, for whom standard treatment has been ineffective, or who are intolerant to standard treatment.

2. With HER2 gene mutation,未经HER2 ex20ins targeted therapy(For example, poziotinib, trastuzumab deruxtecan).

3.At least one measurable lesion, no brain metastasis or stable after brain metastasis treatment.

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