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AbbVie ABBV announced that the FDA has granted accelerated approval to its antibody-drug conjugate (ADC), telisotuzumab vedotin (or Teliso-V), for treating certain patients with non-small cell lung cancer (NSCLC). The drug will be marketed under the brand name Emrelis.
Under this approval, Emrelis is approved to treat adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (OE) who have received a prior systemic therapy. This makes it the first FDA-approved therapy for this patient population.
The drug is designed to target the c-Met protein, which is overexpressed in many solid tumors, including NSCLC. Per AbbVie, c-Met OE is found in 25% of advanced EGFR wild-type NSCLC patients and is associated with a poor prognosis. Approximately half of these patients have high c-Met OE, defined as at least 50% of tumor cells with strong (3+) staining, as determined by an FDA-approved test.
Emrelis’ approval also marks a significant milestone for AbbVie, marking the company's first internally developed solid tumor drug and its first solid tumor therapy to receive FDA approval for lung cancer.
The accelerated approval is supported by data from the phase II LUMINOSITY study, which showed that patients with high c-Met protein OE treated with the drug achieved an overall response rate of 35%. To convert this approval into a full one, AbbVie is conducting a phase III confirmatory study called TeliMET NSCLC-01, evaluating the drug in patients with previously treated c-Met-overexpressing NSCLC.
ABBV Stock Performance
Shares of the company have outperformed the industry year to date, as seen in the chart below.
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ABBV’s Growing Oncology Portfolio
AbbVie has significantly broadened its oncology portfolio over recent years. Initially anchored by Imbruvica and Venclexta, the company has expanded its offerings to include Epkinly, Elahere, and most recently, Emrelis, bringing the total to five oncology therapies.
ABBV also has an exciting and diverse pipeline of promising new therapies in both blood cancers and solid tumors. Notably, etentamig (formerly ABBV-383), a BCMA x CD3 bispecific antibody, is currently being evaluated in a late-stage study for relapsed/refractory multiple myeloma.
The company is also developing another c-Met targeting ADC called Temab-A (formerly ABBV-400). This drug is being evaluated in a late-stage study for metastatic colorectal cancer and in mid-stage development for gastroesophageal cancer.
ABBV Inks Deal With ADARx Pharma to Develop siRNA Therapies
In a separate press release, AbbVie announced a collaboration and license option agreement with ADARx Pharmaceuticals to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology.