AbbVie Reports Positive Phase 2 Results for Telisotuzumab Vedotin in c-Met-Overexpressing NSCLC, Seeks Accelerated Approval

▎WuXi

Edited by Kant Content Team

AbbVie today announced the primary results of the single-arm Phase 2 LUMINOSITY trial, which evaluated its investigational therapy telisotuzumab vedotin (Teliso-V) for the treatment of patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR) wild-type, advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). The analysis showed that the LUMINOSITY trial demonstrated positive clinical benefits at the key endpoint. Detailed data from the study will be presented at an upcoming medical conference.AbbVie will continue patient enrollment in the TeliMET NSCLC-01 Phase 3 clinical trial and discuss with global regulatory authorities the potential to support accelerated approval of the drug.

According to the trial results analyzed by Independent Central Review (ICR),The overall response rates for patients with high and moderate c-Met expression were 35% and 23%, respectively.Moreover, other endpoints demonstrated clinically meaningful outcomes, including a median duration of response of 9 months and 7.2 months for patients with high and moderate c-Met expression, respectively, and a median overall survival of 14.6 months and 14.2 months, respectively.

The safety profile of Teliso-V was consistent with previous results, and no new safety issues were identified. Adverse events with Teliso-V monotherapy were generally manageable and well-tolerated.

Teliso-V is an antibody-drug conjugate (ADC),The drug targets c-Met and uses the microtubule inhibitor MMAE as its cytotoxic payload.. This therapy received FDA Breakthrough Therapy designation in January 2022., for the treatment of non-small cell lung cancer.

[1] AbbVie Announces Positive Topline Results from Phase 2LUMINOSITY Trial Evaluating Telisotuzumab-Vedotin (Teliso-V) for Patients withPreviously Treated Non-Small Cell Lung Cancer (NSCLC). Retrieved November 29,2023 from https://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-2-luminosity-trial-evaluating-telisotuzumab-vedotin-teliso-v-for-patients-with-previously-treated-non-small-cell-lung-cancer-nsclc-302000674.html

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