Sigvotatug vedotin (PF-08046047) - (SigVie-002)
- Indication
- 2L+ Non-squamous Metastatic Non-small Cell Lung Cancer
- Stage
- phase3
- Event
- Phase 3
- Details
August 4, 2026: Pfizer’s Q2 2026 earnings presentation highlighted multiple catalyst updates across its pipeline. Recent approvals/advances included HYMPAVZI (marstacimab) for hemophilia A/B with inhibitors and pediatric expansion, and PADCEV (enfortumab vedotin) in cisplatin-ineligible and cisplatin-eligible muscle-invasive bladder cancer.
Key data updates: LITFULO (ritlecitinib) Phase 3 vitiligo studies (TRANQUILLO/TRANQUILLO-2) showed significant co-primary endpoint improvements at 50 mg and 100 mg, with placebo-adjusted F-VASI75 responses of 19.5% and 19.3% at 52 weeks and sustained effect to week 104. PADCEV + pembrolizumab showed OS benefit across bladder cancer settings: EV-302 HR 0.53, EV-303 HR 0.50, EV-304 HR 0.65. Sigvotatug vedotin Phase 3 SigVie-002 in previously treated non-squamous metastatic NSCLC missed the primary OS endpoint in the overall population, though a one-prior-line subgroup showed median OS 13.6 vs 11.1 months; SigVie-003 remains ongoing. PF’4404 (PD-1xVEGF) Phase 2 monotherapy in 1L PD-L1+ NSCLC showed ORR 68% and median PFS 12.4 months at the selected pivotal dose. Mevrometostat + XTANDI showed 8.1-month median rPFS improvement (14.3 vs 6.2 months; HR 0.51). Berobenatide Phase 2b monthly obesity data supported Phase 3; VESPER-6 started in June 2026.
Upcoming catalysts over the next 12 months include regulatory decisions for ELREXFIO, LITFULO in vitiligo, Lyme disease vaccine candidate PF-07307405, TALZENNA+XTANDI (TALAPRO-3), and TUKYSA (HER2CLIMB-05); readouts for MEVPRO-1 in 4Q 2026, berobenatide + amylin analog in 2H 2026, and additional PF’4404, NURTEC, tilrekimig, and sigvotatug vedotin studies; plus pivotal study starts for PF’4404, atirmociclib, and berobenatide expansion trials.
- Source
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