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TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Published: 2023-10-22 14:30:00 ET
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  • TIVDAK demonstrated statistically significant overall survival, progression-free survival and objective response rate compared to chemotherapy in late-breaking results presented at ESMO 2023 congress
  • Results from innovaTV 301 intended to serve as pivotal confirmatory trial for U.S. accelerated approval and to support global regulatory applications

COPENHAGEN, Denmark & BOTHELL, Wash.--(BUSINESS WIRE)-- Genmab A/S(Nasdaq: GMAB) and Seagen Inc.(Nasdaq: SGEN) announcedadditionalresults today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with TIVDAK demonstrated a statistically significant and clinically meaningful 30 percent reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy (HR: 0.70, 95 percent CI: 0.54-0.89, p=0.0038i). Topline results from innovaTV 301 were disclosed earlier this year following a pre-specified interim analysis conducted through an independent data monitoring committee. The additional results were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress 2023.

“Patients with cervical cancer have few treatment options once their cancer comes back or spreads after initial treatment,” said Ignace B. Vergote, M.D., Ph.D., co-founder of European Network of Gynaecological Oncological Trial groups (ENGOT), and lead investigator on the innovaTV 301/ENGOT cx-12/GOG 3057 clinical trial. “The positive data, seen in a representative patient population of recurrent or metastatic cervical cancer, demonstrate the potential for TIVDAK to reshape clinical practice and provide hope for patients who need a new treatment option.”

TIVDAK demonstrated the following results compared with chemotherapy across primary and key secondary efficacy endpoints:

  • Overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30 percent reduction in the risk of death compared with chemotherapy (Hazard ratio [HR]: 0.70 [95 percent CI: 0.54, 0.89], p=0.0038).
  • Progression-free survival (PFS) results were statistically significant with TIVDAK, demonstrating a 33 percent reduction in the risk of disease worsening or death compared with chemotherapy (HR: 0.67 [95 percent CI, 0.54-0.82], p