Approval of tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

An antibody drug conjugate composed of tissue factor directed human monoclonal antibody covalently linked to the microtubule disrupting agent mono-methyl auristatin E.

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%.

In patients with recurrent cervical cancer, second or third line treatment with tisotuab vedotin resulted in significant greater efficacy than chemotherapy.


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%).





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