Bayer targets leading position in HER2-positive NSCLC
The potential blockbuster HER2 tyrosine kinase inhibitor sevabertinib, developed jointly by Bayer AG and the Broad Institute, is expected to be submitted for regulatory approval in China in Q3 2025 for the treatment of HER2-positive non-small cell lung cancer (NSCLC).
In a pivotal Phase I/II trial, sevabertinib demonstrated an objective response rate (ORR) of 70.5% in pretreated patients, and up to 90% ORR within the subgroup harbouring YVMA insertions. The candidate also exhibited a manageable safety profile. These figures are comparable to those reported for Boehringer Ingelheim’s HER2 inhibitor zongertinib, which is anticipated to receive US regulatory approval in Q3 2025.
By contrast, the current treatment standard for HER2-positive NSCLC—trastuzumab deruxtecan, an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo—achieved an ORR of 55% and reported annual sales of US$1bn. In NSCLC without driver mutations, MSD’s PD-1 inhibitor pembrolizumab recorded an ORR of 44.8%.
According to Research & Markets, the global therapeutics market for NSCLC reached US$27.7bn in 2024.
Boehringer Ingelheim Biopharmaceuticals GmbH
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