Bayer has announced the advancement of its investigational small-molecule drug, BAY 2927088, into a Phase 3 clinical trial (SOHO-02) for the first-line treatment of non-small cell lung cancer (NSCLC) harboring HER2 activating mutations. This move underscores Bayer's ambition to establish itself as a leading oncology player by the end of the decade.
The first patient has been enrolled in the SOHO-02 trial, a study designed to evaluate the efficacy and safety of BAY 2927088 compared to the current standard of care, which consists of MSD's PD-1 inhibitor Keytruda (pembrolizumab) in combination with chemotherapy (cisplatin/carboplatin and pemetrexed).
BAY 2927088 is an orally available drug that combines inhibition of HER2 (including exon 20 insertions and point mutations) with blockade of EGFR. These mutations are frequently observed in NSCLC tumors. The drug has been granted breakthrough therapy designation by both the US FDA and China's regulatory authority as a second-line treatment for HER2-positive NSCLC that has progressed after prior systemic therapy.
Prevalence and Current Treatment Landscape
HER2 alterations are present in 2% to 4% of NSCLC tumors, while EGFR mutations can be found in up to 50% of cases. Research suggests that HER2 alterations may also contribute to resistance in up to 10% of EGFR-mutated NSCLC, indicating a potential role for BAY 2927088 as a complementary therapy to anti-EGFR agents.
Currently, the only FDA-approved therapy specifically for HER2-mutated NSCLC is AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), which is approved for second-line use and administered intravenously. Enhertu received accelerated approval for this indication in 2022.
Upcoming Data Presentation
Bayer is scheduled to present findings from the Phase 1/2 SOHO-01 study of BAY 2927088 as a second-line therapy for HER2-altered NSCLC at the World Conference on Lung Cancer (WCLC) in San Diego on September 9th. These results are eagerly anticipated by the oncology community.
Bayer's Oncology Strategy
Bayer's broader oncology strategy is spearheaded by the prostate cancer drug Nubeqa (darolutamide), which the company projects could achieve over €3 billion in sales with label expansions. Nubeqa is central to Bayer's goal of reaching €10 billion in cancer sales by the end of the decade. BAY 2927088 is a leading candidate in Bayer's internal cancer pipeline, alongside efforts to expand the indications for the oral neurokinin antagonist elinzanetant, which is currently under review for the treatment of menopausal symptoms.
