Bayer's Hyrnuo Enters HER2-Mutated Lung Cancer Market, Challenging Boehringer's Hernexeos

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Bayer's Hyrnuo (sevabertinib) for the treatment of HER2-mutated non-small cell lung cancer (NSCLC), marking a significant development in the pharmaceutical industry's approach to this rare tumor type. This approval positions Hyrnuo as a direct competitor to Boehringer Ingelheim's Hernexeos, which received FDA approval just a few months earlier.

FDA Approval and Clinical Data

Hyrnuo, a tyrosine kinase inhibitor (TKI), is specifically indicated for patients with previously treated nonsquamous NSCLC whose tumors have HER2 activating mutations in the tyrosine kinase domain (TKD). The FDA's decision was based on promising results from Bayer's phase 1/2 Soho-01 trial.

In the study, 71% of patients who had received prior systemic therapy but not HER2-targeted treatment responded to Hyrnuo, with a median response duration of 9.2 months. For patients previously treated with HER2-targeting antibody-drug conjugates, the response rate was 38%, with a median duration of response of seven months.

Market Impact and Patient Population

Bayer estimates that up to 84,000 people are diagnosed with HER2-mutated NSCLC annually, highlighting the potential impact of this new treatment option. Christian Rommel, Ph.D., Bayer's head of R&D, emphasized the significance of this approval in advancing treatment paradigms for patients with this specific mutation.

Competitive Landscape

Hyrnuo's entry into the market closely follows Boehringer Ingelheim's Hernexeos, which received FDA approval in August. Both drugs target the same mutated tumors, but with slight differences in their FDA-approved indications. Hernexeos is approved for unresectable or metastatic NSCLC, while Hyrnuo's label specifies locally advanced or metastatic nonsquamous NSCLC.

In terms of efficacy, Hernexeos demonstrated a 75% objective response rate in its Lung-1 phase 1b trial among patients who had not received prior HER2-targeted therapy. Both companies are now pursuing expanded approval for first-line treatment, with recent data presented at the European Society of Medical Oncology congress showing similar outcomes in treatment-naïve patients.