ENGOT-cx12/GOG-3057/innovaTV 301 trial

The ENGOT-cx12 inovaTV 301 trial, co-authored by Professor Vergote and by Prof Gennigens, is a Phase 3 randomised controlled trial evaluating tisotumab versus physician’s choice of chemotherapy in second or third-line cervical cancer. This well-known trial, previously presented at the ESMO plenary session, enrolled 582 patients and met its primary endpoint of overall survival.

Approximately 64% of the participants received bevacizumab, and around one-third received a PD-1 or PD-L1 inhibitor. The poster presented at ASCO provides a descriptive analysis of the type and timing of subsequent therapies. Around 50% of patients in the tisotumab group and 43% in the chemotherapy group received subsequent therapy, predominantly systemic. The median time between the last dose of the trial drug and the first dose of subsequent therapy was six weeks for the tisotumab group and five weeks for the chemotherapy group. Subsequent chemotherapy was administered to 73% of the tisotumab group and 62% of the chemotherapy group, while subsequent immunotherapy was given to approximately 35% in both groups.

In conclusion, this trial demonstrated improved overall survival with tisotumab and showed that a significant proportion of patients received subsequent treatments. Tisotumab not only provided clinical benefits but also did not hinder the administration of subsequent therapies.