Tisotumab Vedotin

Review

Tisotumab Vedotin

No authors listed

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2023 Nov 30.

PMID: 38190474
Bookshelf ID: NBK598988

Free Books & Documents

Review

Tisotumab Vedotin

No authors listed.

Free Books & Documents

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2023 Nov 30.

PMID: 38190474
Bookshelf ID: NBK598988

Excerpt

Tisotumab vedotin is a human monoclonal antibody conjugate which is used in the therapy of refractory, recurrent or metastatic cervical cancer. Tisotumab vedotin has been linked to transient mild-to-moderate serum aminotransferase elevations during therapy but has not been implicated in cases of liver injury with jaundice.

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1. Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).
1. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761208Orig1s000M...(FDA website with product labels and initial multidiscipline review of tisotumab vedotin mentions that the most common side effects were hemorrhage, fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival and ocular toxicity including dry eyes, corneal ulcers, keratitis and perforation; ALT elevations arose in 24% of patients, but none were above 5 times ULN, there were no drug discontinuations or deaths from liver injury, and no patient developed clinically apparent liver injury with jaundice).
1. de Bono JS, Concin N, Hong DS, Thistlethwaite FC, Machiels JP, Arkenau HT, Plummer R, et al. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20:383-393.(Among 147 patients with miscellaneous advanced or metastatic solid tumors treated with various doses tisotumab vedotin to identify the optimal dose for long term therapy [0.3 to 2.2 mg/kg iv every 3 weeks] the recommended dose was 2 mg/kg, which was associated with an overall response rate of 16% but also a high rate of adverse events including epistaxis, fatigue, nausea, alopecia, conjunctivitis, dry eyes, decreased appetite, constipation, diarrhea, peripheral neuropathy, and abdominal pain; ALT elevations arose in 10%, but were generally mild). - PubMed
1. Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload], including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed
1. Coleman RL, Lorusso D, Gennigens C, González-Martín A, Randall L, Cibula D, Lund B, et al.; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22:609-619.(Among 101 patients with recurrent or metastatic cervical cancer refractory to conventional therapies who were treated with tisotumab vedotin, the overall response rate was 24% and adverse events were frequent, but there was no mention of ALT elevations or hepatotoxicity). - PubMed

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[1] Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).

[2] Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).

[3] FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761208Orig1s000M...(FDA website with product labels and initial multidiscipline review of tisotumab vedotin mentions that the most common side effects were hemorrhage, fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival and ocular toxicity including dry eyes, corneal ulcers, keratitis and perforation; ALT elevations arose in 24% of patients, but none were above 5 times ULN, there were no drug discontinuations or deaths from liver injury, and no patient developed clinically apparent liver injury with jaundice).

[4] FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761208Orig1s000M...(FDA website with product labels and initial multidiscipline review of tisotumab vedotin mentions that the most common side effects were hemorrhage, fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival and ocular toxicity including dry eyes, corneal ulcers, keratitis and perforation; ALT elevations arose in 24% of patients, but none were above 5 times ULN, there were no drug discontinuations or deaths from liver injury, and no patient developed clinically apparent liver injury with jaundice).

[5] de Bono JS, Concin N, Hong DS, Thistlethwaite FC, Machiels JP, Arkenau HT, Plummer R, et al. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20:383-393.(Among 147 patients with miscellaneous advanced or metastatic solid tumors treated with various doses tisotumab vedotin to identify the optimal dose for long term therapy [0.3 to 2.2 mg/kg iv every 3 weeks] the recommended dose was 2 mg/kg, which was associated with an overall response rate of 16% but also a high rate of adverse events including epistaxis, fatigue, nausea, alopecia, conjunctivitis, dry eyes, decreased appetite, constipation, diarrhea, peripheral neuropathy, and abdominal pain; ALT elevations arose in 10%, but were generally mild). - PubMed

[6] de Bono JS, Concin N, Hong DS, Thistlethwaite FC, Machiels JP, Arkenau HT, Plummer R, et al. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20:383-393.(Among 147 patients with miscellaneous advanced or metastatic solid tumors treated with various doses tisotumab vedotin to identify the optimal dose for long term therapy [0.3 to 2.2 mg/kg iv every 3 weeks] the recommended dose was 2 mg/kg, which was associated with an overall response rate of 16% but also a high rate of adverse events including epistaxis, fatigue, nausea, alopecia, conjunctivitis, dry eyes, decreased appetite, constipation, diarrhea, peripheral neuropathy, and abdominal pain; ALT elevations arose in 10%, but were generally mild). - PubMed

[7] Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload], including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed

[8] Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload], including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed

[9] Coleman RL, Lorusso D, Gennigens C, González-Martín A, Randall L, Cibula D, Lund B, et al.; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22:609-619.(Among 101 patients with recurrent or metastatic cervical cancer refractory to conventional therapies who were treated with tisotumab vedotin, the overall response rate was 24% and adverse events were frequent, but there was no mention of ALT elevations or hepatotoxicity). - PubMed

[10] Coleman RL, Lorusso D, Gennigens C, González-Martín A, Randall L, Cibula D, Lund B, et al.; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22:609-619.(Among 101 patients with recurrent or metastatic cervical cancer refractory to conventional therapies who were treated with tisotumab vedotin, the overall response rate was 24% and adverse events were frequent, but there was no mention of ALT elevations or hepatotoxicity). - PubMed

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Tisotumab Vedotin

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