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AbbVie Eyeing Accelerated Approval Pathway for c-Met-Targeted Antibody-Drug Conjugate in NSCLC

NEW YORK – AbbVie on Wednesday said it will discuss with regulators the possibility of accelerated approval for telisotuzumab-vedotin (Teliso-V) as a treatment for c-Met-overexpressing, EGFR wild-type advanced non-small cell lung cancer based on results from the Phase II LUMINOSITY trial.

In the trial, researchers are assessing the safety and efficacy of Teliso-V, a c-Met protein directed antibody-drug conjugate, as a second- or third-line therapy in patients with advanced NSCLC. To be eligible for the trial, patients' tumors must test positive for c-Met overexpression as assessed by immunohistochemistry testing and have histologically documented wild-type EGFR status.

Top-line results from the trial showed that the overall response rate was 35 percent in patients with high c-Met expression in tumors and 23 percent in those with intermediate c-Met expression. For c-Met-high patients, the median duration of response was nine months and median overall survival was 14.6 months. For c-Met-intermediate patients, the median duration of response was 7.2 months and median overall survival was 14.2 months.

The drug's safety profile was consistent with previous studies, and investigators did not observe any new safety signals.

Approximately 25 percent of patients with advanced EGFR wild-type NSCLC have c-Met overexpression, and their prognosis is poor. "The results of the Phase II LUMINOSITY trial are encouraging for those patients with NSCLC with c-Met overexpression as there is a critical need for better care and additional therapy options for them," Ross Camidge, an oncologist at the University of Colorado Cancer Center and principal investigator of the trial, said in a statement.

AbbVie is also studying Teliso-V as a treatment for patients with previously treated c-Met-overexpressing, EGFR wild-type nonsquamous NSCLC in the Phase III TeliMET NSCLC-01 trial.