▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced,Submitted by AbbVie Inc.Infusion Sterile Lyophilized Powder Telisotuzumab VedotinProposed inclusion in the breakthrough therapy category, intended for the treatment of disease progression during or after platinum-based drug therapy.High c-Met protein expression, advanced/metastaticEGFRPatients with wild-type non-squamous non-small cell lung cancer (NSCLC). Public information shows that telisotuzumab vedotin (Teliso-V) is a drug candidate under research by AbbVie.Antibody-Drug Conjugates (ADC) Targeting c-Met, with the microtubule inhibitor MMAE as the cytotoxic payload.

Screenshot source:CDE Official Website

Approximately 85% of lung cancers are classified as non-small cell lung cancer, and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide in both men and women. According to literature reports, about 25% of advancedEGFRc-Met protein overexpression was found in wild-type NSCLC patients.c-Met is a receptor tyrosine kinase that is overexpressed in a variety of tumors, including non-small cell lung cancer.Associated with poor prognosis in patients.

In 2022, Teliso-V was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of advanced/metastatic disease that has progressed during or after platinum-based therapy and exhibits c-Met overexpression.EGFRPatients with wild-type non-squamous NSCLC. This is precisely the case for this product in China.Indications proposed for inclusion in the breakthrough therapy category.

In November 2023, AbbVie announced the primary results of the single-arm Phase 2 LUMINOSITY trial, which evaluated Teliso-V treatment.c-Met protein overexpression,Advanced/MetastaticEGFRPatients with wild-type non-squamous NSCLCThe efficacy. Analysis shows that the LUMINOSITY trial demonstrated positive clinical benefits in key endpoints.

Specifically, 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.. In addition, other endpoints showed clinically meaningful outcomes, including patients with high and moderate c-Met expression.The median durations of response were 9 months and 7.2 months, and the median overall survival times were 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.

According to reports, based on the results of the Phase 2 LUMINOSITY trial, AbbVie will continue patient recruitment for the TeliMET NSCLC-01 Phase 3 clinical trial and discuss with global regulatory authorities the potential to support accelerated approval of the drug.

[2] 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). 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