AbbVie (NYSE:ABBV) recently shared positive top-line data from its phase II LUMINOSITY study on the investigational antibody-drug conjugate (ADC) candidate, telisotuzumab-vedotin (Teliso-V), designed for previously treated non-small cell lung cancer (NSCLC) patients with c-Met overexpression.
The study results, categorized based on c-Met expression levels, revealed an overall response rate (ORR) of 35% for c-Met high patients and 23% for c-Met intermediate patients. While these figures were lower than interim results reported in January last year, where response rates were 53.8% and 25% for c-Met high and intermediate patients, respectively, Teliso-V demonstrated meaningful clinical outcomes in other study endpoints.
Teliso-V exhibited a median duration of response (DoR) of 9 months and 7.2 months, along with a median overall survival (OS) of 14.6 months and 14.2 months for c-Met high and intermediate patients, respectively. The safety profile of Teliso-V remained consistent with previous findings, with no new safety concerns identified.
Despite the lower response rates, AbbVie highlighted the positive clinical outcomes achieved with Teliso-V, especially in terms of DoR and OS. Management plans to discuss these results with regulatory authorities globally, aiming for accelerated approval for Teliso-V in treating c-Met overexpressing NSCLC.
C-Met overexpression, found in 25% of advanced EGFR wild-type NSCLC patients, is associated with a poor prognosis, and there are currently no approved therapies for this condition. Teliso-V, developed by AbbVie to target the c-Met protein overexpressed in various solid tumors, is undergoing evaluation as a monotherapy in the late-stage TeliMET NSCLC-01 study for previously treated c-Met overexpressing EGFR wild-type non-squamous NSCLC.
AbbVie is also conducting an early-stage study exploring Teliso-V in combination with approved drugs, including AstraZeneca’s EGFR inhibitor Tagrisso (osimertinib), across a range of c-Met-expressing solid tumors. Tagrisso, a blockbuster drug for AstraZeneca, recorded $4.4 billion in product sales in the first nine months of 2023.
Despite a year-to-date decline of 14.3% in AbbVie’s shares, the promising results from the Teliso-V study signify a potential breakthrough in addressing the unmet medical needs of NSCLC patients with c-Met overexpression.
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