Abbvie's solid tumor strategy wins in lung cancer by accelerating FDA approval
Treatment options are reduced when lung cancer progresses after initial treatment. AbbVie drugs provide patients with new options as the first FDA-approved treatment for advanced cases of non-small cell lung cancer (NSCLC) driven by specific cancer proteins.
The FDA said Wednesday it approved the drug, Telisotuzumab Vedotin, brand Emrelis, to cover the treatment of local advanced or metastatic non-quantum NSCLC. Eligible patients must have received at least one previous systemic therapy and their disease must also express a protein called C-MET.
Although C-MET plays a role in normal cellular processes, dysregulation of this protein may lead to cancer growth. According to Abbvie, C-MET is overexpressed in cases of advanced non-quantum NSCLC where the EGFR gene does not have any mutations. In these patients, about half of C-MET is overexpressed. These are patients Emrelis can treat under the product label. In addition to the approval of the drug, the FDA also approved the Roche partner diagnosis to identify patients eligible for the drug.
Emrelis belongs to cancer therapy called antibody drug conjugates (ADCs). The antibody component of Emrelis targets C-MET and delivers it to cells expressing the drug payload of the protein AA a vedotin (chemotherapy). The AbbVie drug is injected every two weeks as an intravenous infusion.
Emrelis' regulatory submission was based on an open-label phase 2 study that included 84 patients who had systemic treatment for lung cancer. The results show that the overall response rate is 35%. The median duration of the response was 7.2 months. The most common adverse reactions reported in the study were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Data from the study were presented last year at the annual meeting of the American Society of Clinical Oncology.
“In recent decades, we have observed a paradigm shift in cancer that can better select and optimize treatment outcomes,” said Dr. Jonathan Goldman, UCLA professor of medicine and director of clinical trials at Thoracic Oncology. “People with C-MET overexpressing NSCLC have poor prognosis and limited treatment options, while Emrelis is a top-notch ADC that can address the critical unmet needs of this patient population.”
Emrelis' regulatory decision is based on accelerated approval of the results of the second phase. To retain approval, the drug must verify clinical benefits in larger confirmed clinical trials. This phase 3 study is already underway with a target enrollment of 698 patients. Emrelis treatment was compared with Docetaxel, a standard chemotherapy for advanced NSCLC.
Two of the best-selling products in the Abbvie Oncology portfolio are Imbruvica and Venclexta, both large oral small molecule drugs sold by partners to treat several types of blood cancer. Abbvie's oncology strategy includes expanding its portfolio with drugs that address solid tumors. Emrelis comes from Abbvie's internal ADC research. The company said the product represents its first in-house developed solid tumor drug and its first solid tumor FDA approval in lung cancer. Abbvie also pursues C-MET with another ADC, Telisotuzumab Adizutecan. The drug's clinical program spans NSCLC, colorectal cancer and gastroesophageal adenocarcinoma.
Abbvie's cancer drug line already has commercial ADCs. Elahere, the first ADC to acquire ovarian cancer, joined Abbvie's portfolio through Immunogen, the developer that acquired the drug in 2023. The protocol includes IMGN151, the next generation ADC for ovarian cancer currently being tested in Phase 1. Other ADCs in the ABBVIE conduit include ABBV-706 for small cell lung cancer, central nervous system tumors and neuroendocrine cancers, and ABBV-969 for prostate cancer. Both are in early clinical development.
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