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Tisotumab Vedotin Exhibits Antitumor Activity in NSCLC, Among Other Cancers

By: Joseph Fanelli
Posted: Tuesday, March 5, 2019

Tisotumab vedotin, an in-human antibody-drug conjugate directed against tissue factor, yielded responses in 13% of patients with non–small cell lung cancer (NSCLC), as well as multiple other cancer types, with a reportedly manageable safety profile, according to findings presented in The Lancet Oncology. Based on these results from the InnovaTV201 phase I/II clinical trial, further studies are needed to confirm this antitumor activity, concluded Johann de Bono, PhD, of The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, both in London, and colleagues.

“What is so exciting about this treatment is that its mechanism of action is completely novel. It acts like a Trojan horse to sneak into cancer cells and kill them from the inside,” Dr. de Bono said in an ICR press release. “We are also developing a test to pick out the patients most likely to respond.”

Researchers enrolled patients with relapsed, advanced, or metastatic cancer of the ovaries, cervix, endometrium, bladder, prostate, and esophagus; squamous cell carcinoma of the head and neck; or NSCLC (15 patients). These patients were from 21 centers in the United States and Europe. In the dose-escalation phase of the trial, 27 patients were treated with tisotumab vedotin once every 3 weeks. In the dose-escalation phase, 147 patients were treated at the recommended phase II dose (2 mg/kg intravenously once every 3 weeks).

Across all tumor types, 15.6% of patients achieved a confirmed objective response; 27% of patients with bladder cancer and 13.3% of patients with NSCLC responded to the novel treatment. The most common treatment-emergent adverse events of any grade were epistaxis (69% of patients), fatigue (56%), and nausea (52%).

Disclosure: The study authors’ disclosure information may be found at thelancet.com.



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