The US FDA has granted accelerated approval to Boehringer Ingelheim’s HERNEXEOS (zongertinib tablets) for adults with advanced non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations.

 

The approval is based on compelling early trial data showing a high rate of tumor response. In the Phase Ib Beamion LUNG-1 trial, treatment-naïve patients achieved an objective response rate of 76%, with 11% experiencing complete responses and 65% partial responses. 

 

Notably, 64% of patients maintained their response for six months or longer. Boehringer Ingelheim is now enrolling patients in the Phase III Beamion LUNG-2 trial to confirm these results as a first-line therapy.

 

“Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy, a manageable safety profile, and once daily oral administration,” said John Heymach, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center and coordinating investigator for the Beamion LUNG-1 trial. 

 

“Now these patients finally have a targeted treatment option that they can receive immediately following identification of a HER2 mutation.”

 

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, added, “With HERNEXEOS now approved for patients with HER2-mutant advanced NSCLC as an initial treatment option, we are delivering on our promise to transform care for people with this rare and aggressive cancer. This approval marks a shift towards personalized care with a targeted treatment option for patients with HER2 mutated lung cancer. It underscores our relentless focus on accelerating innovation to address a significant unmet need.”

 

HER2 (ERBB2) mutations occur in roughly 2–4% of NSCLC cases and are linked to poor outcomes and a higher risk of brain metastases. These genetic alterations drive uncontrolled tumor growth by promoting cell proliferation and inhibiting cell death.

 

“We first learned about the HER2 genetic mutation as a lung cancer driver in a small subset of patients more than 20 years ago,” said Danielle Hicks, Chief Patient Officer of GO2 for Lung Cancer. 

 

“Half of these people do not respond to the current standard of care, which is why it is vital to provide them with a treatment option that has been designed specifically for their disease. Understanding your biomarkers is so important because it can unlock more personalized and effective treatment options.”