Bayer AG’s BAY2927088 recently received the Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Following approval, BAY2927088 is expected to face intense competition in the epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) but limited competition in the human epidermal growth factor receptor 2 (HER2)-exon 20 mutant NSCLC market in China, says GlobalData.
BAY2927088 is an oral, tyrosine kinase inhibitor (TKI) that inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as EGFR, with high selectivity for mutant vs. wild-type EGFR in adult patients with unresectable or metastatic NSCLC and who have received prior systemic therapy.
The Breakthrough Therapy designation is supported by data from the Phase I/II, open-label, multi-centre, first-in-human study to evaluate the safety, pharmacokinetics, and preliminary efficacy of BAY2927088 as second-line therapy in adult patients with advanced NSCLC harbouring HER2 and EGFR mutations.
Nelluri Geetha, Pharma Analyst at GlobalData, comments, “EGFR/HER2 exon 20 insertion mutations are resistant to available EGFR tyrosine kinase inhibitors (TKIs) and anti-HER2 treatments and correlate with a poor patient prognosis. Therefore, there is an urgent need for novel and innovative treatment options to improve survival in this patient population.”
The current marketed drug space for NSCLC in China includes Programmed Cell Death Protein 1 (PD1 or CD279 or PDCD1) antagonists (Keytruda, Opdivo, Tyvyt), Vascular Endothelial Growth Factor A Inhibitor (Avastin), ALK Tyrosine Kinase Receptor Inhibitors (Alecensa, Zykadia, Bemena), and EGFR Inhibitors (Tagrisso, Iressa). However, none of these approved drugs can address the unmet needs of patients with EGFR/HER2-mutant NSCLC.
Globally, there are three approved second-line drugs for the treatment of EGFR exon 20 insertion mutations, namely Exkivity (Takeda Pharmaceuticals), Rybrevant (Janssen Inc) and Zegfrovy (Dizal Pharmaceutical Co Ltd). Among these, only Exkivity (January 2023) and Zegfrovy (August 2023) are approved in China.
In China, the drugs in the pipeline for NSCLC with exon 20 insertion mutations include pyrotinib (Irene, Phase II – first line and Phase III – second and third line) for HER2 exon 20 mutations from Jiangsu Hengrui Medicine Co Ltd and amivantamab (Rybrevant, Phase III – second line) for EGFR exon 20 mutations from Janssen Inc.
According to GlobalData’s Pharmaceutical Intelligence Center, Exkivity sales are expected to increase from $67 million in 2023 to $181 million by 2029 for NSCLC in China. In China, for NSCLC, both Irene and Rybrevant are expected to generate sales of $20 million and $320 million by 2029, respectively.
“Following approval, BAY2927088 is expected to face intense competition in EGFR mutant NSCLC space mainly from two approved drugs, Exkivity and Zegfrovy, and late-stage pipeline drug Rybrevant, whereas limited competition is expected in HER2 mutant NSCLC space mainly from Irene (Phase III) in China,” concludes Geetha.
Edits made by EP News Bureau