Approval of tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Phase 2 innovaTV 204 trial in which the antibody-drug conjugate elicited an objective response rate (ORR) of 24% per independent review committee using RECIST criteria in patients with recurrent or metastatic cervical cancer who received prior doublet chemotherapy and bevacizumab.
7% experienced a complete response and 17% had a partial response.
The median duration of response with tisotumab vedotin was 8.3 months.
Tisotumab vedotin at a dose of 2.0 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
68% of patients had squamous cell carcinoma, 27% had adenocarcinoma, and 5% had adenosquamous carcinoma.
Almost all patients, or 94%, had extrapelvic metastatic disease at baseline.
4% of those who received the ADC achieved disease stability while 24% experienced disease progression
Seventy-nine percent of participants also experienced a reduction in target lesions.
The median PFS reported with the ADC was 4.2 months, while the OS was 12.1 months.
The PFS rate at 6 months was 30%, while the OS rate at this time point was 79%.
Boxed warnings: ocular toxicity, as well as warning for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity.
The adverse effects most frequently reported with tisotumab vedotin included hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%).