Pfizer’s first ADC following its Seagen acquisition, sigvotatug vedotin (SV), failed to meet the primary overall survival endpoint in a Phase 3 trial in advanced, metastatic non-squamous NSCLC. The setback adds to pressure on Pfizer’s ADC strategy and complicates expectations for the asset’s future development. In the SigVie-002 study (formerly Be6A-Lung-01), SV did not achieve statistical significance versus docetaxel in the overall population. Pfizer reported a stronger trend in patients who had received only one prior line of systemic therapy, a subgroup representing about two-thirds of enrolled patients. Pfizer said safety was manageable and consistent with prior studies, but it did not identify a clear response relationship to integrin beta-6 expression. The company is continuing with subgroup-based analysis and also running an ongoing Phase 3 Keytruda combination effort.
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