FDA Grants Telisotuzumab Vedotin Accelerated Approval in c-MET+ NSCLC
The FDA granted accelerated approval to telisotuzumab vedotin for the treatment of NSCLC with high c-MET protein overexpression.
US FDA
- The FDA has granted telisotuzumab vedotin-tllv (Teliso-V; Emrelis) accelerated approval in locally advanced or metastatic, nonsquamous non–small cell lung cancer (NSCLC) that harbors high c-MET protein overexpression who have received a prior systemic therapy.
- Data from the phase 2 LUMINOSITY trial (NCT03539536) support this regulatory decision.
- This is the first and only approved therapy for previously treated patients with advanced NSCLC with high c-Met protein overexpression.
The FDA granted accelerated approval to telisotuzumab vedotin for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC with high c-MET protein overexpression who have received previous systemic therapy.1
According to the phase 2 LUMINOSITY trial, the study that serves as the basis of this regulatory decision, when given to 84 patients with high c-MET protein overexpression, which is defined as strong (immunohistochemistry [IHC] 3+) staining on at least 50% of tumor cells, based on an FDA-approved test, telisotuzumab vedotin led to an overall response rate (ORR) of 35% (95% CI, 24%-46%) and a median duration of response (DOR) of 7.2 months (95% CI, 4.2-12).
For safety, the most commonly seen adverse events (≥20%) included peripheral neuropathy, fatigue, decreased appetite and peripheral edema. Grade 3 or 4 laboratory abnormalities (≥2%) observed consisted of decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
Regarding patient-reported outcomes with telisotuzumab vedotin, “…what we see is that the other parameters, other symptoms, quality of life and physical functioning, are maintained along with the treatment with Teliso-V who are able also to look at time to deterioration in quality of life, which is again a way to have an insight into the balance between efficacy and safety. And actually, it was more prolonged time to deterioration of quality of life. It was more prolonged not only in responders, but also in patients with stable disease,” said Nicolas Girard, MD, PhD, thoracic oncologist at the Institut Curie in Paris, France, and investigator on the LUMINOSITY trial.
Illustration of lungs: © yodiyim - stock.adobe.com
"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman, MD, professor of medicine and director of Thoracic Oncology Clinical Trials at UCLA, in a press release. "People with c-MET overexpressing NSCLC have poor prognosis and limited treatment options, and [telisotuzumab vedotin] is a first-in-class ADC that can address a critical unmet need for this patient population."
Telisotuzumab vedotin is a c-Met-directed ADC. This approval makes it the first and only treatment to be approved for the treatment of this patient population.
In addition, the FDA granted approval to Roche's VENTANA MET (SP44) RxDx Assay as an IHC companion diagnostic to identify patients who may be eligible for treatment with the antibody-drug conjugate (ADC).
Telisotuzumab vedotin is also currently being evaluated alone for the potential treatment of patients with previously treated c-Met overexpressing NSCLC within a randomized, phase 3, confirmatory trial titled TeliMET NSCLC-01. Enrollment in this global study is ongoing.
