Tisotumab vedotin (1) – Tivdak®

• Clinical trials
  • The innovaTV 301 trial is an open-label, randomised Phase III trial comparing tisotumab vedotin with chemotherapy selected by the investigator.

a) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after first-line platinum-based chemotherapy, who have not been pre-treated with a PD-(L)1 antibody and who are eligible for further standard systemic antineoplastic therapy

• An additional benefit is not proven.
• The pharmaceutical manufacturer did not submit any data in the dossier for patient group a to assess the additional benefit of trastuzumab vedotin compared with the appropriate comparator therapy.

b) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after - platinum-free first-line chemotherapy without a PD-(L)1 antibody, – first-line combination therapy comprising chemotherapy and a PD-(L)1 antibody, – sequential therapy with platinum-containing chemotherapy and a PD-(L)1 antibody, and for whom further standard systemic antineoplastic therapy is an option

• The additional benefit is not proven.
• The pharmaceutical manufacturer presents the results for the overall population of the innovaTV 301 study for patient group b.
• However, the data on the overall population are not suitable for assessing the additional benefit for patient group b, as the study mainly included female patients who had not been pre-treated with a PD-(L)1 antibody.
• For patient group b, no data were submitted for the relevant patient population that met the criteria regarding prior treatment and the implementation of the appropriate comparator therapy.
• Consequently, no suitable data are available for comparison with the appropriate comparator therapy.

c) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after prior systemic therapy and for whom further standard systemic antineoplastic therapy is not an option

• An additional benefit is not proven.
• In the dossier, the pharmaceutical manufacturer did not provide any data for patient group c to assess the additional benefit of trastuzumab vedotin compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.