Bayer chases Boehringer

Bayer has got the FDA nod for its HER2 mutant-targeted asset sevabertinib, setting up a battle against Boehringer Ingelheim’s Hernexeos. Like Hernexeos, sevabertinib – now branded Hyrnuo – has accelerated approval for second-line non-squamous HER2-mutant NSCLC. It’s hard to separate the two drugs, with both producing similar efficacy in their registrational studies: Hyrnuo showed an ORR of 71% among 70 patients in Soho-02, according to the FDA, while Hernexeos produced a 75% ORR among 71. Side effects could be a consideration: Hernexeos’s label contains warnings for hepatotoxicity, left ventricular dysfunction and interstitial lung disease, with no boxed warnings. Hyrnuo’s label isn’t yet available, but the FDA cites warnings for diarrhoea, hepatotoxicity, ILD, ocular toxicity and pancreatic enzyme elevation – suggesting an edge for Hernexeos on safety. The Boehringer drug might also be more convenient, as it’s given once daily, versus twice daily for Hyrnuo. The next battleground is first-line HER2m NSCLC, where the therapies have again shown similar efficacy and safety. However, diarrhoea looked problematic with Hyrnuo, at 84%, compared with 54% with Hernexeos. Confirmatory trials in first-line disease could start yielding data as early as next year. HER2 mutations are said to occur in 2-4% of NSCLC patients.

Cross-trial comparison of Hyrnuo vs Hernexeos in second-line HER2m NSCLC

Source: OncologyPipeline.