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Solid TumorsMarch 2019

What Researchers Found Testing Tisotumab Vedotin Across Solid Tumors

This first-in-human study tested tisotumab vedotin — an antibody-drug conjugate targeting tissue factor on tumors — in 147 people with various advanced cancers. Tumors shrank in about 16% across the mix; the drug went on to win FDA approval in cervical cancer.

What the trial was testing

The InnovaTV 201 enrolled 195 patients with solid tumors. The study was sponsored by Seagen and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

16% tumor response rate across heavily pretreated solid tumors.

The Lancet Oncology · 2019 · NCT02001623

These findings — that across multiple advanced solid tumors in this first-in-human dose-finding study — were published in the The Lancet Oncology and represent the headline result of the study.

Researchers tracked outcomes across 195 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with solid tumors, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Tisotumab vedotin (Tivdak) is FDA-approved for advanced cervical cancer that has progressed after chemotherapy and is available now. Eye-related side effects are notable and require an eye care plan during treatment. Ask a gynecologic oncologist if it fits your case.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.