AbbVie has said that the Phase II trial also demonstrated meaningful clinical outcomes, including median duration of response and median overall survival. Image credit: Shutterstock / Kateryna Kon.

Biopharma giant AbbVie has announced that pipeline candidate Teliso-V (telisotuzumab-vedotin) demonstrated a clinically meaningful overall response rate (ORR) in a Phase II trial of patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

The Phase II LUMINOSITY trial (NCT03539536) evaluated Teliso-V in previously treated NSCLC patients with c-Met protein overexpression and epidermal growth factor receptor (EGFR) wild-type.

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Teliso-V is an investigational first-in-class, c-Met protein-directed antibody-drug conjugate (ADC).

The endpoints measured ORR, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) as determined by an independent central review (ICR), as well as overall survival (OS).

Principal investigator Dr Ross Cambridge said that the Phase II results provide confidence as AbbVie continues the enrolment in the Phase III TeliMET NSCLC-01 trial (NCT04928846).

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Results of Phase II LUMINOSITY trial

The results demonstrated an ORR of 35% in c-Met High patients and 23% in c-Met Intermediate patients.

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Other endpoints demonstrated clinically meaningful results, including a median DoR of nine months and seven months, and a median OS of 14.6 months and 14.2 months across c-Met High and c-Met Intermediate patients, respectively.

The safety profile was consistent with previous studies and no new safety concerns were identified with adverse events well managed and tolerated. Full data will be presented at a future medical meeting along with AbbVie’s plans for accelerated approval with global health authorities.

Teliso-V was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and Taiwanese health authorities; as well as SAKIGAKE drug designation by the Pharmaceuticals and Medical Devices Agency in Japan, which is designed to provide easier access to novel advanced treatments. It has also been awarded an Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

GlobalData’s Pharmaceutical Intelligence Centre predicts a global sales forecast for the candidate of $483m in 2029. AbbVie has a market cap of £244bn.

The Pharmaceutical Intelligence Centre also states that Telsio-V is involved in eight clinical trials, two completed, one planned and five ongoing.

GlobalData is the parent company of the Clinical Trials Arena.