The trial is evaluating tisotumab vedotin administered every 3 weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer.
Seattle Genetics announced positive topline results from the single-arm, phase 2 innovaTV 204 trial evaluating tisotumab vedotin administered every 3 weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer.
"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," Roger Dansey, MD, chief medical officer at Seattle Genetics, the co-developer of the agent, said in a press release. "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."
The ongoing single-arm, global, multicenter study is evaluating tisotumab vedotin – which 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 – for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab (Avastin). Patients included in the study were those who had previously received up to 2 prior lines of therapy in the metastatic setting.
The primary end point of the trial was confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety, and tolerability.
Overall, 101 patients were treated with tisotumab vedotin at multiple centers across the US and Europe. Results from the trial demonstrated a 24% confirmed ORR by independent central review (95% CI, 15.9%-33.3%) with a median DOR of 8.3 months. The most common treatment-related adverse events included alopecia, epistaxis, nausea, conjunctivitis, fatigue, and dry eye.
Data from this trial will be submitted for presentation at an upcoming medical meeting.
Standard therapies for this patient population generally result in limited ORRs of often <15% with median OS ranging from 6.0 to 9.4 months, in an all-comers population. In 2020, over 13,500 women are predicted to be diagnosed with cervical cancer in the US, and approximately 4200 are anticipated to die.
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. Moreover, tisotumab vedotin is also being assessed in other tissue factor expressing tumor types, including ovarian and other solid tumors.
Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer [news release]. Published June 29, 2020. finance.yahoo.com/news/seattle-genetics-announces-positive-topline-203000842.html. Accessed June 30, 2020.