Pfizer's Phase 3 Study of Sigvotatug Vedotin Misses Overall Survival Endpoint

MT Newswires Live
Jun 23

Pfizer (PFE) said late Monday that topline results from the phase 3 SigVie-002 study showed that sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival compared with docetaxel.

Sigvotatug vedotin is an investigational, potential first-in-class integrin beta-6-directed antibody-drug conjugate.

The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer who had received one or more lines of prior therapy.

Patients who had received only one prior line of systemic therapy represented about two-thirds of the study population. In that group, sigvotatug vedotin showed a stronger trend for overall survival and progression-free survival than docetaxel.

Pfizer said the safety profile of sigvotatug vedotin was manageable and consistent with prior studies.

The company also said no clear IB6 expression-response relationship was observed in the exploratory analysis.

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