FDA Approves EMRELIS for Advanced NSCLC With High c-Met Overexpression

AbbVie, a global biopharmaceutical company, has announced the U.S. FDA's accelerated approval of EMRELIS (telisotuzumab vedotin-tllv) for adults with advanced non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression. This approval marks a significant development for patients with limited treatment options and a poor prognosis.

EMRELIS is a c-Met-directed antibody-drug conjugate (ADC), uniquely approved for this patient demographic. ADCs are designed to identify and attach to specific biomarkers, such as the c-Met protein, and deliver potent treatment directly to affected cells. High c-Met overexpression is found in about 25% of advanced EGFR wild type, non-squamous NSCLC patients, half of whom have tumors with strong c-Met staining in more than 50% of cells.

This approval is based on the overall response rate (ORR) and duration of response (DOR) metrics. A confirmatory trial is required to establish further clinical benefits. The LUMINOSITY Phase 2 study, pivotal to this approval, showcased promising results for EMRELIS. Among high c-Met overexpressing patients, a 35% overall response rate and a median response duration of 7.2 months were observed. Common adverse reactions included peripheral neuropathy, fatigue, and decreased appetite, while some patients experienced significant laboratory abnormalities like decreased lymphocytes and increased glucose.

Jonathan Goldman, MD, from UCLA, emphasized the shift in oncology towards personalized treatments guided by biomarkers, which optimize treatment outcomes. He noted that EMRELIS addresses a critical need for NSCLC patients with c-Met overexpression, offering a new therapeutic option.

Roopal Thakkar, MD, AbbVie's executive vice president of research and development, highlighted EMRELIS as AbbVie’s first approved solid tumor medicine in the lung cancer domain. This achievement reflects AbbVie's dedication to advancing cancer therapy using innovative technology and data science to develop ADCs that meet specific patient needs.

Despite advancements in lung cancer treatment, the disease remains the leading cause of cancer-related deaths globally, with non-small cell lung cancer accounting for roughly 85% of cases. The c-Met protein, overexpressed in significant portions of these cancers, is linked to dire prognoses and highlights the need for targeted therapies like EMRELIS.

AbbVie is further evaluating EMRELIS in a Phase 3 global confirmatory study, TeliMET NSCLC-01, as a monotherapy for previously treated patients with high c-Met overexpression. Patient enrollment for this trial is ongoing worldwide.

Additionally, the FDA has sanctioned the Roche VENTANA MET (SP44) RxDx Assay, an immunohistochemistry (IHC) diagnostic tool to identify patients eligible for EMRELIS treatment. This approval underscores the importance of precise biomarker identification in administering personalized therapies.

AbbVie is committed to facilitating access to EMRELIS through various patient support programs, aiming to alleviate financial burdens for eligible patients. This includes potential reductions to out-of-pocket expenses and assistance for those without comprehensive health insurance.

EMRELIS is a targeted therapy comprising a c-Met-binding antibody linked to a cytotoxic agent, monomethyl auristatin E (MMAE). This combination is designed to attack c-Met expressing cancer cells effectively. The significance of c-Met as a therapeutic target in NSCLC, given its association with poor outcomes, underscores the promise of EMRELIS in altering treatment landscapes for patients with few options.

Through ongoing research and partnerships, AbbVie continues to explore and develop innovative cancer treatments, striving to make a profound impact on patient care and addressing the unmet needs in oncology.