Bayer Announces BAY 2927088 Receives Breakthrough Therapy Designation in Both China and the U.S. for HER2-Mutant NSCLC

China Finance and Economics News, June 11th: Bayer announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has recently granted Breakthrough Therapy Designation to Bayer's novel targeted lung cancer treatment drug BAY 2927088. The indication is for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) who carry HER2-activating mutations and have previously received one systemic therapy.

BAY 2927088 is a tyrosine kinase inhibitor under research by Bayer. It is being developed as a potential novel targeted therapy for the treatment of non-small cell lung cancer (NSCLC) patients with HER2-activating mutations. In February this year, BAY 2927088 received Breakthrough Therapy Designation from the U.S. FDA.

According to reports, in order to encourage the research and development of drugs with significant clinical advantages, the NMPA has established a breakthrough therapy drug review process. The scope of application includes innovative drugs or improved new drugs used during clinical trials for the prevention or treatment of diseases that seriously endanger life or significantly affect the quality of life, where there are no effective preventive or therapeutic methods available, or where there is sufficient evidence demonstrating clear clinical advantages compared to existing treatments.

The latest global cancer burden data released in 2024 show that there were 2.48 million new cases of lung cancer in 2022, accounting for 12.4% of the total number of new cancer cases worldwide, making it the most common cancer globally once again. Meanwhile, lung cancer is also the leading cause of cancer-related deaths, with an estimated 1.8 million people dying from lung cancer, representing 18.7% of the total number of global cancer deaths in 2022. NSCLC is the most common type of lung cancer, accounting for over 85%. HER2 activating mutations are found in 2% to 4% of advanced NSCLC cases, with a higher incidence of HER2 mutations in Asian populations compared to European and American populations. The incidence rate of HER2-mutated NSCLC in China is 4.3%.

BAY 2927088 is an orally reversible tyrosine kinase inhibitor that effectively inhibits mutant human epidermal growth factor receptor 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as exhibits high selectivity for mutant epidermal growth factor receptor (EGFR) compared to the wild-type. The breakthrough therapy designation was based on preliminary clinical evidence from a Phase I, open-label, multicenter first-in-human study (NCT05099172), which evaluated the safety, pharmacokinetics, and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR mutations.

Li Qi, Vice President of Bayer's Prescription Medicine Division and Head of Beijing R&D Center and China Regulatory Affairs, introduced that HER2 has been confirmed as a therapeutic target for NSCLC, and drugs for anti-HER2 treatment are also under continuous exploration. However, currently, there are no fully approved available therapies for metastatic or advanced NSCLC patients with HER2 activating mutations. "Early clinical evidence shows that BAY 2927088 has the potential to benefit NSCLC patients carrying HER2 mutations whose disease has progressed after previous systemic treatments. BAY 2927088 successively received 'Breakthrough Therapy' designations in both China and the U.S., which is another demonstration of Bayer’s commitment to continuously innovating to address unmet medical needs in the field of cancer treatment. We will continue to collaborate with relevant departments to accelerate the advancement of clinical research, providing innovative treatment options for a large number of lung cancer patients and clinicians in China, transforming the treatment landscape, and improving patient outcomes."