Bayer’s lung cancer treatment BAY2927088 recently earned Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Post-approval, BAY2927088 is anticipated to encounter fierce competition in the epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) market, while facing limited competition in the human epidermal growth factor receptor 2 (HER2)-exon 20 mutant NSCLC segment in China, as per GlobalData, a prominent data and analytics firm.
BAY2927088 is an oral tyrosine kinase inhibitor (TKI) targeting mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as EGFR, with high selectivity for mutant versus wild-type EGFR in adult patients with unresectable or metastatic non-small cell lung cancer who have undergone prior systemic therapy.
The Breakthrough Therapy designation is underpinned by data from a Phase I/II, open-label, multi-center, first-in-human study evaluating the safety, pharmacokinetics, and preliminary efficacy of BAY2927088 as a second-line therapy in adult patients with advanced NSCLC harboring HER2 and EGFR mutations.
Urgent Need for Novel Treatments in EGFR/HER2-Mutant Lung Cancer
Nelluri Geetha, Pharma Analyst at GlobalData, remarked: “EGFR/HER2 exon 20 insertion mutations are resistant to existing EGFR TKIs and anti-HER2 treatments, correlating with poor patient prognosis. Thus, novel and innovative treatment options are urgently needed to improve survival in this patient population.”
Currently, the non-small cell lung cancer drug market in China includes PD-1 antagonists (Keytruda, Opdivo, Tyvyt), VEGF-A inhibitors (Avastin), ALK TKI (Alecensa, Zykadia, Bemena), and EGFR inhibitors (Tagrisso, Iressa). However, none of these approved drugs address the unmet needs of patients with EGFR/HER2-mutant NSCLC. Globally, three approved second-line drugs for EGFR exon 20 insertion mutations are Exkivity (Takeda Pharmaceuticals), Rybrevant (Janssen Inc), and Zegfrovy (Dizal Pharmaceutical Co Ltd). Only Exkivity (January 2023) and Zegfrovy (August 2023) are approved in China.
China’s Lung Cancer Market: Rising Competition for Exon 20 Mutation Drugs
In China, NSCLC drugs in the pipeline for exon 20 insertion mutations include pyrotinib (Irene, Phase II for first line and Phase III for second and third line) for HER2 exon 20 mutations from Jiangsu Hengrui Medicine Co Ltd, and amivantamab (Rybrevant, Phase III for second line) for EGFR exon 20 mutations from Janssen Inc.
GlobalData’s Pharmaceutical Intelligence Center predicts Exkivity sales in China to rise from $67 million in 2023 to $181 million by 2029 for non-small cell lung cancer. In China, Irene and Rybrevant are expected to generate sales of $20 million and $320 million respectively by 2029 for NSCLC. Geetha concludes: “Post-approval, BAY2927088 will likely face intense competition in the EGFR mutant non-small cell lung cancer space primarily from two approved drugs, Exkivity and Zegfrovy, and the late-stage pipeline drug Rybrevant. In contrast, limited competition is expected in the HER2 mutant NSCLC space, mainly from Irene (Phase III) in China.”
Resource: GlobalData, June 25, 2024
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