Treatment with tisotumab vedotin-tftv monotherapy led to an improvement in overall survival compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy.
Treatment with tisotumab vedotin-tftv (Tivdak) monotherapy led to an improvement in overall survival (OS) compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy, meeting the primary end point of the phase 3 innovaTV 301 trial (NCT04697628).1
An independent data monitoring committee determined that data for OS crossed the prespecified efficacy boundary at the trial’s interim analysis. Improvements in investigator-assessed progression-free survival and objective response rate—key secondary end points—also reached statistical significance with tisotumab vedotin. Safety data from innovaTV 301 were consistent with the known safety profile of tisotumab vedotin, and no new safety signals were observed.
Full data from innovaTV 301 will be presented at an upcoming medical meeting and shared with regulatory authorities.
“[Tisotumab vedotin] is the only US FDA–approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy,” Roger Dansey, MD, president of research and development and chief medical officer at Seagen, stated in a news release. “Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option.”
In September 2021, the FDA granted accelerated approval to tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.2 That regulatory decision was based on data from the phase 2 innovaTV 204 trial (NCT03438396), and innovaTV 301 is intended to serve as the pivotal confirmatory trial for the accelerated approval and support global regulatory applications.1
The global, randomized, open-label, phase 3 study enrolled patients at least 18 years of age with recurrent or metastatic cervical cancer of squamous cell, adenocarcinoma, or adenosquamous histology who experienced disease progression during or after treatment with a standard-of-care systemic chemotherapy doublet or platinum-based therapy.3 One or two prior systemic therapy regimens for recurrent and/or metastatic cervical cancer was required, and neoadjuvant/adjuvant chemotherapy with or without radiation therapy was not counted as a systemic therapy regimen. Other inclusion criteria included measurable disease per RECIST v1.1 criteria, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months.
Patients with primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria; clinically significant bleeding issues or risks; or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke were excluded.
Investigators randomly assigned 502 patients to 2.0 mg/kg of tisotumab vedotin every 3 weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed (Alimta).1,3
Other secondary end points included time to response, duration of response, safety, and quality of life.
“With limited options for advanced cervical cancer patients who have progressed after front-line therapy, there is a need for therapeutic options with new mechanisms of action, particularly those with a demonstrated survival benefit,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a news release. “These results provide hope for patients with recurrent or metastatic cervical cancer.”