Pfizer Inc. (NYSE:PFE) today announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy.

  • In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival (OS) compared to docetaxel.
  • The safety profile of sigvotatug vedotin was manageable and consistent with prior studies.
  • Encouragingly, in patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and progression-free survival (PFS) for sigvotatug vedotin over docetaxel.
  • In the exploratory analysis, no clear IB6 expression-response relationship was observed.

Detailed results from SigVie-002 will be submitted for presentation at a future medical congress.