# innovaTV 301: tisotumab vedotin versus chemotherapy as second- or third-line therapy for recurrent cervical cancer

Source: https://onco.cc/key-papers/paper-innovatv-301-tisotumab-nejm-2024/  
OnCo record `paper-innovatv-301-tisotumab-nejm-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The tissue factor-directed antibody-drug conjugate tisotumab vedotin lengthened survival compared with chemotherapy in cervical cancer that had progressed after first-line treatment, at the cost of eye and nerve side effects.

## Summary

Phase 3 trial of 502 patients with recurrent or metastatic cervical cancer after one or two prior systemic regimens randomised to tisotumab vedotin or investigator's choice chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed).

Median overall survival was 11.5 versus 9.5 months (hazard ratio 0.70), progression-free survival 4.2 versus 2.9 months and objective response 17.8 versus 5.2 percent; ocular events, peripheral neuropathy and bleeding were the characteristic toxicities.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2024
- DOI: 10.1056/NEJMoa2313811
- Authors: Vergote I, González-Martín A, Fujiwara K, et al.
- Findings: Median overall survival 11.5 vs 9.5 months; hazard ratio 0.70.; Objective response 17.8 percent vs 5.2 percent.
- What it means: Tisotumab vedotin is the standard second-line treatment for recurrent cervical cancer after chemo-immunotherapy, with a mandatory eye-care protocol.
- Caveats: Modest absolute gains.; Conjunctivitis and keratitis require prophylactic eye drops and regular examinations.

## Sources

- N Engl J Med 2024: https://doi.org/10.1056/NEJMoa2313811
- PubMed: https://pubmed.ncbi.nlm.nih.gov/38959480/

## Connected records

- cancers: [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/)
- drugs: [Tisotumab vedotin](https://onco.cc/drugs/tisotumab-vedotin/)
- trials: [innovaTV 301 / ENGOT-cx12 / GOG-3057](https://onco.cc/trials/innovatv-301/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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