Published February 28, 2024

Bayer’s BAY 2927088, a reversible tyrosine kinase inhibitor (TKI) developed in collaboration with the Broad Institute of MIT and Harvard, is currently undergoing a Phase I trial projected to enroll 460 patients. The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Bayer for BAY 2927088 in the treatment of non-small cell lung cancer (NSCLC).

This orally administered drug selectively targets mutant forms of HER2 and EGFR and is intended for adults with unresectable or metastatic NSCLC harboring HER2 mutations, who have previously not responded to systemic therapy.

As a result of this designation, Bayer is entitled to expedited review processes and additional guidance from the FDA, facilitating the development plan for BAY 2927088.

The FDA’s decision was based on data from Bayer’s Phase I/II trial (NCT05099172) assessing the drug’s efficacy and safety in adults with NSCLC carrying mutations in HER2 and/or EGFR genes, as announced in a press release on February 26.

The trial, with an estimated enrollment of 460 participants, focuses on primary endpoints including safety, pharmacokinetics, and preliminary efficacy assessments.

Non-small cell lung cancer (NSCLC) is the leading cause of lung cancer-related deaths, claiming approximately 135,000 lives in 2021. Currently, the only FDA-approved therapy for NSCLC with HER2 mutations is Daiichi Sankyo and AstraZeneca’s Enhertu. Although granted accelerated approval in August 2022, it must demonstrate further positive results in confirmatory trials for full approval.