Bayer lung cancer drug gets fast FDA approval to stay competitive with Boehringer Ingelheim Med
A Bayer drug designed to target tumors driven by rare genetic mutations has received accelerated FDA approval, providing another treatment option for some patients with advanced lung cancer.
A regulatory decision on Wednesday for Bayer's drug sevabertinib covers the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with mutations in HER2, also known as ERBB2. In addition to carrying this mutation, patients eligible for Bayer's drug must also have cancer that has progressed after at least one prior systemic therapy. In addition to approving the drug, which is branded Hyrnuo, the FDA also approved a companion diagnostic from Life Technologies to identify patients who may be eligible for treatment with Bayer's twice-daily pill.
HER2 is a cell surface receptor that helps regulate normal cell growth. HER2 mutations may cause cancer. These mutations are rare, found in approximately 2% to 4% of NSCLC cases. Hyrnuo is an oral, small molecule, mutant HER2 inhibitor.
Bayer evaluated Hyrnuo in a single-arm, open-label Phase 1/2 study in previously treated patients. Among 70 patients who had not received treatment for HER2 mutations, the results showed an objective response rate of 71%. The median duration of response was 9.2 months; among people who responded to treatment, 54% had responses that lasted six months or longer.
Among 52 participants who had received prior systemic therapy, including AstraZeneca and HER2-targeting antibody-drug conjugates such as Daiichi Sankyo's Enhertu, Bayer's drug had an objective response rate of 38%. The median duration of response was 7.0 months; 60% of patients who responded to treatment had a duration of response of six months or longer. Detailed results were published last month in the New England Journal of Medicine.
Although Enhertu is an option for patients with advanced NSCLC, the drug carries a risk of interstitial lung disease. Bayer's drug is not immune to this risk. The FDA noted that interstitial lung disease is one of the potential complication risks associated with Hyrnuo. Other side effects reported in clinical trials include diarrhea, hepatotoxicity, ocular toxicity, and elevated pancreatic enzymes.
The FDA's decision on Hyrnuo is based on accelerated approval based on Phase 1/2 data. Bayer may be required to provide additional clinical data to confirm the safety and effectiveness of the product.
Hyrnuo's approval follows the accelerated approval in August of Boehringer Ingelheim's zongertinib (trade name Hernexeos), an oral HER2-targeted drug also being developed for cases of advanced NSCLC. While both drugs are approved for the same indication, Boehringer Ingelheim's drug has the advantage of once-daily dosing.
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