Pfizer Launches Phase III Trial of ITGB6 ADC Sigvotatug Vedotin Plus PD-1 Inhibitor Keytruda as First-Line Therapy for PD-L1-High NSCLC

▎Armstrong

On January 3, 2025, Pfizer registered a Phase III clinical trial on Clinicaltrials.gov for the ITGB6 ADC new drug Sigvotatug Vedotin + Keytruda in combination as a first-line treatment for PD-L1 high-expression non-small cell lung cancer.

This Phase III clinical trial plans to enroll 714 patients with advanced PD-L1 high-expression non-small cell lung cancer, in a head-to-head comparison with Keytruda monotherapy, with preliminary completion expected by 2028.

This is Pfizer's second Phase III clinical trial围绕Sigvotatug Vedotin, following the initiation of a Phase III clinical trial for second-line and above treatment of NSCLC.

Sigvotatug Vedotin is a first-in-class ITGB6 ADC new drug globally.

At this year's ASCO meeting, Pfizer disclosed Sigvotatug V.Data from the Phase I clinical trial of edotin in NSCLC show an ORR of 19.5%, with the ORR reaching 32.5% in the subgroup of non-squamous NSCLC patients who have not received prior taxane treatment.

Summary

After acquiring Seagen, ADC has become a key focus area for Pfizer, with ITGB6 ADC and PD-L1 ADC as the core R&D pipelines to expand its presence in the lung cancer field. PD-(L)1+ADC has become a battleground for MNCs, with Merck, Bristol-Myers Squibb, AstraZeneca, Pfizer, Roche, GlaxoSmithKline, and others actively in-licensing ADC drugs to expand their PD-(L)1 combination therapy toolbox.