Seattle Genetics Doses First Patient In Ph II Trial of Antibody-drug Conjugate in Multiple Solid Tumors

July 12, 2018
  • Trial is Enrolling Patients with Colorectal, Non-Small Cell Lung, Pancreatic or Head and Neck Cancers
  • Earlier study demonstrated an encouraging response rate in patients with relapsed, recurrent and/or metastatic cervical cancer
  • Tisotumab vedotin is being co-developed by Seattle Genetics, Inc. and Genmab A/S.



Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of the first patient in the phase 2 innovaTV 207 clinical trial evaluating the activity, safety and tolerability of tisotumab vedotin as monotherapy in selected solid tumors with high Tissue Factor expression. Tissue Factor is overexpressed in a broad range of solid tumors that are associated with a poor prognosis. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen on the surface of cancer cells and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. Tisotumab vedotin is being developed in collaboration with Genmab A/S. The potentially pivotal phase 2 trial innovaTV 204 evaluating tisotumab vedotin for patients with cervical cancer who have relapsed and/or progressed after standard of care treatment was recently initiated.

“The initiation of the phase 2 innovaTV 207 basket trial will enable us to explore the safety and activity of tisotumab vedotin in several tumor types where Tissue Factor is also expressed and is intended to inform a potentially broad development program that maximizes the opportunity for this ADC beyond cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). In cancer biology, Tissue Factor is a protein involved in tumor cell signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach. In an earlier study, tisotumab vedotin demonstrated an encouraging response rate and manageable safety profile in patients with relapsed, recurrent and/or metastatic cervical cancer.

The phase 2 innovaTV 207 trial is a global, multicenter, open label basket trial that will enroll up to 200 adult patients with relapsed, locally-advanced or metastatic disease in one of four cohorts: colorectal cancer, squamous non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, and squamous cell cancer of the head and neck (SCCHN). Patients will be treated with single-agent tisotumab vedotin every three weeks. The primary endpoint of the trial is confirmed objective response rate (ORR) defined as the proportion of patients who achieve a confirmed complete or partial response. Key secondary endpoints include confirmed and unconfirmed ORR, disease control rate, duration of response, progression-free survival, overall survival, safety and tolerability.

Tisotumab vedotin is being co-developed by Seattle Genetics, Inc. and Genmab A/S.



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