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Bayer Granted FDA Breakthrough Therapy Designation for Non-Small Cell Lung Cancer Drug


BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non-small cell lung cancer with tumors that have activating HER2 mutations.

Image credit: Axel Kock | stock.adobe.com

Image credit: Axel Kock | stock.adobe.com

Bayer’s novel small molecule tyrosine kinase inhibitor (TKI) BAY 2927088 has been granted Breakthrough Therapy designation by the FDA to treat unresectable or metastatic non-small cell lung cancer (NSCLC) with tumors that have activating human epidermal growth factor receptor 2 (HER2) mutations in patients who were previously administered systemic therapy.1 The oral, reversible TKI is a highly potent and selective inhibitor of HER2 exon 20 insertions, HER2 point mutations, and epidermal growth factor receptors (EGFR).

“Early clinical evidence suggests that BAY 2927088, our investigational novel oral tyrosine kinase inhibitor, has the potential to benefit patients with NSCLC harboring a HER2 mutation that have progressed on a prior systemic therapy and currently have no other approved treatment available,” Dominik Ruettinger, MD, PhD, head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division, said in a press release. “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.”1

NSCLC encompasses any type of epithelial lung cancer besides small cell lung cancer, which typically shows higher sensitivity to chemotherapy and radiation therapy. The most common types of the disease are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma.

Resectable NSCLC can be cured with surgery or surgery followed by chemotherapy; however, it is uncommon to achieve a cure in these patients. Those with locally advanced unresectable NSCLC may be able to achieve long-term survival with a combination of radiation therapy plus chemotherapy, whereas those with advanced metastatic disease may experience improved survival and palliation of symptoms with the administration of chemotherapy, targeted agents, and other supportive actions.2

The FDA based its designation on data from a Phase I/II trial (NCT05099172) that evaluated BAY 2927088 in adults with advanced NSCLC that harbors HER2 or EGFR mutations.

Data presented at the European Society for Medical Oncology conference from the dose-escalation and backfill parts of the trial showed significant anti-tumor activity and a manageable safety profile with a dose of up to 60 mg per day of BAY 2927088 in patients with HER2– or EGFR-mutated NSCLC.3

As of the data cutoff data of August 18, 2023, patients administered BAY 2927088 showed an overall response rate (ORR) of 26%, with one complete response, 13 partial responses (PR), and an unconfirmed PR. ORR was 60% in those with HER2 exon 20 insertion mutant disease. Across the overall patient population, 29% achieved stable disease (SD) and 29.0% showed progression of disease (PD). Among a subgroup of patients with the HER2 exon 20 mutation, 30.0% achieved SD and 5.0% experienced PD. In the overall population, the disease control rate was 55.1%, reaching 80.0% in the subgroup of patients with the HER2 exon 20 mutation.

In terms of safety, five patients had dose-limiting toxicities, including three in the twice-daily 40 mg dose group, one in the twice-daily 30 mg dose group, and one at the daily 60 mg dose. There were no discontinuations reported as a result of treatment-related adverse effects; however, 26.3% had their doses reduced.


1. Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations. Bayer. News release. February 26, 2024. Accessed February 26, 2024. https://www.bayer.com/media/en-us/bayer-receives-us-fda-breakthrough-therapy-designation-for-bay-2927088-for-non-small-cell-lung-cancer-harboring-her2-activating-mutations/

2. Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version. National Cancer Institute. Webpage. Updated February 16, 2024. Accessed February 26, 2024. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_4

3. Loong HHF, Daniel G, Yang T, et al. Early evidence of efficacy in patients (pts) with non-small cell lung cancer (NSCLC) with HER2 exon20 insertion (ex20ins) mutations treated in a phase I study with BAY 2927088. Ann Oncol. 2023;34(suppl 2):S755-S851. doi:10.1016/j.annonc.2023.09.2409

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