Abstract 12P
Background
Tisotumab vedotin (TV) is an antibody-drug conjugate used for the treatment of adult patients with recurrent or metastatic cervical cancer. TV comprised of a monoclonal antibody against tissue factor and monomethyl auristatin E (MMAE), a potent inhibitor of cell division.
Methods
This is a systematic review of data about the safety and antitumor activity of TV in cervical cancer patients.
Results
The innovaTV-201 and innovaTV-204/GO30xx/ENGOT-cx6 trials showed that TV has clinically meaningful and durable anti-tumor activity in pre-treated patients with recurrent or metastatic cervical cancer. The innovaTV-204 trial showed that TV monotherapy resulted in an objective response rate of 24% (including 7% and 17% complete and partial responses, respectively). In September 2021, the US Food and Drugs Administration (FDA) granted accelerated approval to TV for the treatment of recurrent or metastatic cervical cancer patients with disease progression on or after chemotherapy. The ongoing randomized, open-label Phase 3 innovaTV-301/ENGOTcx12/GOG-30xx trial will assess the effect of TV alone vs. the investigator’s choice of chemotherapy in second- or third-line recurrent or metastatic cervical cancer. Meanwhile, the multicohort phase 1b/2 trial ENGOT Cx8/GOG 3024/innovaTV-205 is testing the combination with TV alone and in combination with (i) bevacizumab, (ii) carboplatin, (iii) pembrolizumab, and (iv) pembrolizumab plus carboplatin with or without bevacizumab. The preliminary data highlighted the feasibility of the combination due to a good toxicity profile and suggest good clinical activity. In the first line, TV in combination with carboplatin or pembrolizumab provides an ORR of 55% and 41%, respectively. The effect of adding TV to the current standard of care in first-line (pembrolizumab plus carboplatin with or without bevacizumab) is still under evaluation.
Conclusions
Several trials tested the role of TV monotherapy for pre-treated recurrent or metastatic cervical cancer. Although the phase III randomized controlled trial (ENGOT-cx12/GOG-3057/innovaTV-301) is still enrolling, the available evidence from phase II studies supports the adoption of TV in pre-treated recurrent or metastatic cervical cancer patients.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.