Bayer has landed an accelerated US approval for its non-small cell lung cancer (NSCLC) therapy, Hyrnuo (sevabertinib), expanding the drug’s role into the frontline treatment setting within an indication linked to poor patient prognosis.
As per the US Food and Drug Administration’s (FDA) recommendation, Hyrnuo will now become available as a frontline treatment option for adults with locally advanced or metastatic, non-squamous NSCLC – specifically if they have HER2 (ERBB2) tyrosine kinase domain-activating mutations, as determined by an FDA-approved test.
This accelerated approval marks a move up the treatment paradigm for Hyrnuo, an oral tyrosine kinase inhibitor (TKI), which was previously indicated for use in patients who had relapsed after systemic therapy.
The agency gave Hyrnuo the regulatory blessing based on the outcomes of the open-label, single-arm SOHO-01 study (NCT05099172), in which the drug demonstrated an objective response rate (ORR) of 75%. Of the patients that were classified as responders, 73% continued to respond at the six-month timepoint, while 38% were found to be responsive to treatment at the 12-month mark.
With Hyrnuo only securing the FDA’s blessing on an accelerated basis, Bayer will have to further demonstrate the therapy’s effectiveness through its ongoing post-marketing confirmatory trial, dubbed SOHO-02 (NCT06452277). This study is pitting Hyrnuo against standard of care (SoC) in untreated patients with advanced, HER2-mutant NSCLC.
Fulfilling unmet needs in HER2-mutated NSCLC
According to a 2026 paper published in Lung Cancer, HER2 mutations are found in between 1.8%-5.6% of NSCLC cases, though their presence is often linked to poor outcomes in patients due to their association with brain metastases.
Because of this, Bayer’s EVP of global product strategy and commercialisation, Christine Roth notes that Hyrnuo’s tentative frontline approval is an “important milestone” for patients, who are in “critical need for additional treatment options.”
Hyrnuo’s debut in the frontline treatment paradigm is also notable due to the requirement for a patient to receive molecular testing before receiving the drug – a theme that is becoming increasingly prevalent with the advent of personalised medicine that is catered to a patient’s specific tumour profile.
Thus far, multiple tissue and liquid biopsy-based tests have secured the FDA go-ahead for identifying HER2 mutations in NSCLC. This includes Guardant Health’s Guardant360 CDx, despite its recent embroilment in a patent battle with TwinStrand, and Life Technologies Corporation’s Oncomine Dx Target Test, which secured the FDA’s approval alongside Boehringer Ingelheim’s rival TKI, Hernexeos (zongertinib).
HER2-mutated NSCLC market heats up
While Hyrnuo has become the latest targeted therapy to secure a frontline approval in this subset of NSCLC, it will have to compete with Boehringer’s Hernexeos, which has the first-to-market advantage following its February 2026 accelerated approval in the frontline setting.
In previous conversation with Clinical Trials Arena, sister publication to Pharmaceutical Technology, thoracic oncologist Dr Balasz Halmos noted that it would be hard to separate between the efficacy and safety of Hyrnuo and Hernexeos.
Meanwhile, Dr Roy Herbst, chief of medical oncology at Yale New Haven Hospital previously touted the first-line response rates linked to Hyrnuo as “extremely high”, though he stated that it would likely be best to combine the drug with chemotherapy, “especially after the positive results of the FLAURA-2 trial looking at Tagrisso plus chemotherapy.”
