Genmab Announces Phase 3 Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Media Release


COPENHAGEN, Denmark, Jan. 04, 2021

• Initiation of a global phase 3 trial for tisotumab vedotin versus investigator’s choice chemotherapy in recurrent or metastatic cervical cancer
  
  

Genmab A/S (Nasdaq: GMAB) announced today the initiation of innovaTV 301 trial, a global phase 3 study to evaluate the efficacy of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy. The innovaTV 301 trial is a global, randomized phase 3 trial in which tisotumab vedotin will be compared with physician’s choice single agent chemotherapy.

“Currently, there is no established standard of care for women with recurrent or metastatic cervical cancer, who have disease progression after first or second line of therapy. There is a need for a novel, safe and effective treatment option that can improve the clinical outcome for these patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to the innovaTV 301 trial which is designed to support potential regulatory applications for marketing approval globally and serve as a confirmatory trial for a potential accelerated approval in the US for patients with metastatic or recurrent cervical cancer.”

About the innovaTV 301 Trial
The open label, randomized, global, phase 3 trial of tisotumab vedotin versus chemotherapy will enroll approximately 482 patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy for their recurrent or metastatic disease. Eligible patients will be randomized to receive either tisotumab vedotin 2.0 mg/kg every three weeks or investigator’s choice of chemotherapy. The primary endpoint of the study is overall survival. This global study will be sponsored and performed by Seagen Inc. in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG).

About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.¹ Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.