(edited: there is an added comment about market potential) Seattle Genetics’ results from the phase 2 of trial testing tisotumab vedotin to treat patients with relapsed or progressed metastatic cervical cancer, showed clinically meaningful and durable objective responses with a manageable safety profile.
The company on Tuesday announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. In the press release, the company said that the results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review [95% Confidence Interval: 15.9%-33.3%] with a median duration of response (DOR) of 8.3 months.
The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye.
Tisotumab vedotin is being developed by Seattle Genetics in collaboration with Genmab.
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases.
“Available therapies upon progression after first line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “Tisotumab vedotin has demonstrated clinically meaningful and durable objective responses with a manageable safety profile, and we look forward to discussing with the FDA the potential submission of a Biologics License Application to support an accelerated approval.”
Additional clinical trials of tisotumab vedotin are currently enrolling patients, including in combination with pembrolizumab, carboplatin or bevacizumab, and with a weekly dosing schedule in patients with locally advanced or metastatic cervical cancer. Tisotumab vedotin is also being evaluated in other tissue factor expressing tumor types, including ovarian and other solid tumors.
In an email to Pharmaceutical Daily, the company said it is premature to comment on the market potential as TV is not approved. There is significant unmet medical need for women with recurrent/metastatic cervical cancer. Once patients progress on or after first-line treatment, there are few treatment options with limited activity. “We are encouraged by the 204 data and plan to discuss the results with the FDA. We will be able to provide more detail once we know the regulatory pathway.”