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Pfizer Announces Topline Phase 3 Results for Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Pfizer announced topline results from the Phase 3 SigVie-002 study for sigvotatug vedotin. The drug did not show a statistically significant improvement in overall survival compared to docetaxel in the overall patient population. However, a stronger trend for survival and progression-free survival appeared in patients who had received only one prior line of therapy.

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What changed

Pfizer released topline Phase 3 results showing the drug failed to meet its primary endpoint for overall survival.

Live updates

  1. Pfizer's Sigvotatug Vedotin Misses Primary Goal in Phase 3 Lung Cancer Trial

    Pfizer announced topline results from the Phase 3 SigVie-002 study for sigvotatug vedotin. The drug did not show a statistically significant improvement in overall survival compared to docetaxel in the overall patient population. However, a stronger trend for survival and progression-free survival appeared in patients who had received only one prior line of therapy.

    What's confirmed:

    • The SigVie-002 study evaluated sigvotatug vedotin in adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer.
    • Sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel in the overall population.
    • Patients who received only one prior line of systemic therapy showed a stronger trend for overall survival and progression-free survival.
    • The safety profile of sigvotatug vedotin was manageable and consistent with prior studies.
    • Sigvotatug vedotin is an investigational, potential first-in-class integrin beta-6 directed antibody-drug conjugate.

    Still unconfirmed:

    • Pfizer's 43 billion dollar Seagen acquisition bet is souring further due to this failure.
    • PFE stock is reacting to these mixed topline results.
    confidence 100%