FDA nods to make Boehringer Ingelheim drug an alternative to AstraZeneca ADC in lung cancer
Lung cancer powered by the mutated HER2 protein already has targeted therapy, namely the huge therapies of Astrazeneca and Daiichi sankyo. The Boehringer Ingelheim drug was approved by the same indication, providing patients with easier drug options and showing better safety and tolerance.
The approval of the Boehringer-ingelheim drug Zongertinib covers the treatment of adults who cannot be resected or metastatic non-mass non-small cell lung cancer (NSCLC). In addition to tumors with HER2 mutations (also known as ERBB2), patients eligible for treatment must have received at least one systemic therapy. Boehringer's new lung cancer drug is a once-daily tablet that will be sold under the Hernexeos brand. The FDA also approved the HELTOS Fisher Scientific Companion diagnosis, which identifies HER2 mutations, qualifying patients with Hernexeos.
NSCLC is the most common type of lung cancer. HER2 is a protein that plays a role in cell growth and division. It is abundant in certain types of cancer and can promote the growth and spread of the cancer when it is mutation. According to Boehringer Ingelheim in Germany, these mutations are rare, with about 2% to 4% of cases of NSCLC. Lung cancer driven by HER2 mutations is associated with poor prognosis and higher incidence of brain metastasis.
Hernexeos is a specially designed oral small molecule inhibitor designed to inhibit HER2. This drug belongs to the category of drugs called tyrosine kinase inhibitors (TKIS). The FDA approval of the drug is based on data from the Open Label Phase 1B study and is divided into two parts: the first evaluates patients with advanced solid tumors with the HER2 gene, while the second specializes in patients with NSCLC with HER2 mutations. In the lung cancer section, the results showed a target response rate of 75%. 69% of patients had partial responses, and a response duration of six months or longer was observed in 58% of patients.
The most common adverse event reported in the Hernexeos test is diarrhea. Liver complications were also observed in the study, with the Hernexeos tag warning clinicians to monitor signs of such problems, including drug-induced liver damage. The full data for the study was presented in April at the American Cancer Research Association's annual meeting in April and published in the New England Journal of Medicine.
In Boehringer's announcement of Hernexeos approval, John Heymach, MD, MD, president of chest/head and neck medical oncology at Anderson Cancer Center, University of Texas, noted that researchers in the drug's research pointed out the drug's lasting response and its manageable safety.
“In the patient population with currently limited treatment options, this approval represents a significant advance in cancer care,” Heymach said.
The black box warning does not list the safety precautions identified on the Hernexeos tag, which is reserved for serious and potentially life-threatening complications. Astrazeneca and daiichi sankyo Drug eNertu labels do carry black box warnings to have a risk of interstitial lung disease. ENHERTU belongs to the category of targeted therapies called antibody drug conjugates (ADCs). The risks vary from one ADC to another, but many of these products come with boxed warnings on their labels. These drugs are also injected as intravenously, which puts higher drug delivery burden on patients than oral small molecules.
Initially approved for the treatment of HER2-positive breast cancer, Enhertu added NSCLC to its label in 2022. Astrazeneca and Daiichi Sankyo have a share of ADC commercialization, which accounted for $3.7 billion in revenue of all approval instructions approved last year.
Private Boehringer isn't the only company trying to compete with verbal small molecules designed to provide better safety and tolerance. In May, the FDA received Bayer's submission of sevabutinib as a treatment for NSCLC with previously systemic therapy with HER2 mutations. The application is reviewed and accepted with priority, meaning regulatory decisions may be made against Bayer drugs in the second half of this year.
Boehringer did not respond to inquiries about Hernexeos price and release date. The regulatory decision for the drug is based on the results of its Phase 1B tests to accelerate approval. Retention approval depends on positive results of confirmatory studies. Ongoing Phase 3 study is evaluating Hernexeos as a first-line treatment for advanced NSCLC adults driven by HER2 mutations. The study drug is being compared with Merck immunotherapy KeyTruda plus chemotherapy. The main goal of this open-label 416 patient study was to measure progression-free survival. Preliminary data expected by the end of 2026.
Photo: Kettel/Ullstein Bild, by Getty Images
