Tisotumab Vedotin Exhibits Antitumor Activity in Bladder Cancer, Among Other Cancers
Posted: Wednesday, March 27, 2019
Tisotumab vedotin, an in-human antibody-drug conjugate directed against tissue factor, yielded responses in 27% of patients with bladder cancer—the highest of any cancer type tested—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, 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 (15 patients), prostate, and esophagus; squamous cell carcinoma of the head and neck; or non–small cell lung cancer. 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 as well as 26.5% of patients with cervical cancer 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