Express AbbVie's ADC therapy is recognized by the FDA as a breakthrough therapy for the treatment of non-small cell lung cancer

▎The content team editor of WuXi AppTec On January 4, 2022, AbbVie announced that the US FDA has granted the breakthrough therapy designation (BTD) for the antibody conjugate drug (ADC) telisotuzumab vedotin (Teliso-V) under development.
It is used to treat patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild-type non-squamous non-small cell lung cancer (NSCLC) who have disease progression and c-Met overexpression during or after platinum drug treatment
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 According to statistics from the World Health Organization (WHO), lung cancer is the leading cause of cancer deaths worldwide in 2020
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There are more than 2 million new cases of lung cancer worldwide, and about 1.
8 million people have died of lung cancer
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Teliso-V is the ADC project with the fastest R&D progress in the AbbVie pipeline
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The drug targets c-Met and uses the tubulin inhibitor MMAE as its toxic payload
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c-Met is a receptor tyrosine kinase that is overexpressed in many tumors including NSCLC
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Currently, there is no approved anti-cancer therapy for the treatment of patients with c-Met overexpressing NSCLC
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The BTD designation is supported by an ongoing Phase 2 clinical trial
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The purpose of the trial is to determine the c-Met overexpression NSCLC population who is most suitable for Teliso-V monotherapy in the second-line or third-line treatment setting, and then to further evaluate the efficacy in the selected population
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The primary endpoint of the trial is the overall response rate (ORR) of the patient based on the central review during the follow-up of ≥12 weeks
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The results of the interim analysis showed that in EGFR wild-type non-squamous NSCLC patients, the ORR of the c-Met high expression group was 53.
8%, and the ORR of the c-Met expression group was 25.
0%
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In addition, Teliso-V combined with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Osimertinib (osimertinib, Teresa), a phase 1 clinical trial for the treatment of NSCLC patients with overexpression of c-Met under treatment Also in progress
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In the future, the company will further evaluate the efficacy of Teliso-V monotherapy in patients with NSCLC overexpression of c-Met in a randomized phase 3 clinical trial
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"Patients with non-small cell lung cancer have high unmet needs, and Teliso-V is expected to provide them with an additional treatment option to manage their disease
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" said Dr.
Mohamed Zaki, AbbVie's vice president and global head of oncology clinical development "This breakthrough therapy identification is an important step towards the goal of developing innovative therapies for multiple cancer types and improving the standard of care for cancer patients
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"References: [1] AbbVie Announces US FDA Granted Breakthrough Therapy Designation (BTD) to Telisotuzumab Vedotin (Teliso-V) for Previously Treated Non-Small Cell Lung Cancer.
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