FDA Grants Breakthrough Therapy Designation to Telisotuzumab Vedotin for Advanced EGFR Wild Type nsqNSCLC


Telisotuzumab vedotin has shown interim efficacy in patients with advanced or metastatic EGFR wild-type non–small cell lung cancer and has now been granted breakthrough therapy designation from the FDA

The FDA has granted a breakthrough therapy designation to telisotuzumab vedotin (ABBV-399) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy, according to a press release by AbbVie.

Telisotuzumab vedotin is an antibody-drug conjugate that targets c-Met, a receptor tyrosine kinase that is overexpressed in NSCLC tumors. Currently, the drug has no regulatory approvals, and studies to determine its safety and efficacy are underway.

"Patients with non-small cell lung cancer have a high unmet need and Teliso-V has the potential to provide them with an additional treatment option to manage their disease," said Mohamed Zaki, MD, PhD, vice president and global head of Oncology Clinical Development at AbbVie, in a press release.

Data from the phase 2, open-label LUMINOSITY clinical trial (Study M14-239) support the BTD for telisotuzumab vedotin. The study aims to determine the safety and efficacy of second- or third-line treatment with telisotuzumab vedotin in 233 patients with previously treated c-Met-positive NSCLC. The study’s primary end point is objective response rate, and the secondary end points include duration of response, disease control rate, progression-free survival, and overall survival.

According to interim analysis data, treatment with telisotuzumab vedotin achieved a 53.8% ORR among patients with a high c-Met and an ORR of 25.0% in the c-Met intermediate group. The study is ongoing at 252 locations across the United States, Australia, Europe, and Asia.

To be eligible for the study, patients are required to have histologically confirmed locally advanced or metastatic disease with known EGFR status, and an ECOG performance status of 0 or 1. Patients are also required to have c-Met-positive NSCLC and be previously treated with at least 2 prior systemic therapies.

The study excludes patients gave received prior c-Met-targeted antibody-based therapies, have adenosquamous histology, and those with central nervous system metastases. Additional patients may be excluded due to comorbidities and active infection.

"Today's announcement marks an important step in our mission to advance new oncology treatments across tumor types to improve standards of care for patients with cancer," Zaki added.

In addition to updated results that are expected from LUMINOSITY, a phase 3 study of telisotuzumab vedotin (TeliMET NSCLC-01; NCT04928846) monotherapy will investigate its efficacy and safety in patients with c-Met overexpressing NSCLC.


1. AbbVie announces U.S. FDA granted breakthrough therapy designation (btd) to telisotuzumab vedotin (Teliso-V) for previously treated non-small cell lung cancer. News release. AbbVie. January 5, 2021. Accessed January 5, 2021. https://prn.to/3HBCUZD

2. Study of telisotuzumab vedotin (ABBV-399) in participants with previously treated c-met+ non-small cell lung cancer. Clinicaltrials.gov. Accessed January 5, 2021. https://bit.ly/3zr93jQ

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