Bayer’s BAY 2927088 Gets Breakthrough Therapy Designation

US FDA grants breakthrough therapy designation to Bayer’s BAY 2927088 for NSCLC harbouring HER2 activating mutations

Overview

Bayer announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.

Lung Cancer: 

• Lung cancer is the leading cause of cancer-related deaths worldwide. 
• NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. 
• Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 
• Currently there are no available therapies that have received full approval in the US for patients with NSCLC in the metastatic or advanced setting harbouring HER2 activating mutations.

Role of Preliminary Clinical Evidences

The Breakthrough Therapy designation is supported by preliminary clinical evidence from the phase I, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harbouring HER2 or EGFR.

Scientist Statement from Bayer’s

• “Early clinical evidence suggests that BAY 2927088, our investigational novel oral tyrosine kinase inhibitor, has the potential to benefit patients with NSCLC harbouring a HER2 mutation that have progressed on a prior systemic therapy and currently have no other approved treatment available,” said Dominik Ruettinger, M.D., Ph.D., head of research and early development for oncology at Bayer’s Pharmaceuticals Division. 
• “This Breakthrough Therapy designation is a significant milestone in our relentless efforts to develop innovative therapies for the treatment of lung cancer characterized by specific genomic markers. 
• We will continue working closely with the FDA to advance BAY 2927088 through the clinic and look forward to providing these patients with lung cancer and their physicians with a targeted, effective treatment option.”

About Breakthrough Therapy Designation

The FDA's Breakthrough Therapy designation is intended to expedite the development and review of drug candidates that treat serious or life-threatening diseases or conditions, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

About BAY 2927088

BAY 2927088 was derived from Bayer’s long-standing strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

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