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: neither drug has a boxed warning, but Hernexeos’s label carries warnings for hepatotoxicity, left ventricular dysfunction and interstitial lung disease; Hyrnuo’s label includes warnings for diarrhoea, hepatotoxicity, ILD, ocular toxicity and pancreatic enzyme elevation. This suggests a slight 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 HyrnuoHernexeosCompanyBayerBoehringer IngelheimTrialSoho-01, cohort DBeamion Lung-1, cohort 1ORR71% (50/70)75% (53/71)DOR ≥6mths54%58%Boxed warning?NoNoWarningsDiarrhoea, hepatotoxicity, ILD/pneumonitis, ocular toxicity, pancreatic enzyme elevation, embryo-fetal toxicityHepatotoxicity, left ventricular dysfunction, ILD/pneumonitis, embryo-fetal toxicityAdministrationOral, twice dailyOral, once dailyConfirmatory trialSoho-02 (1st-line), completes Apr 2027Beamion Lung-2 (1st-line), completes Nov 2026Source: OncologyPipeline.