LBA32 Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: Results from the phase II innovaTV 204/GOG-3023/ENGOT-cx6 study

Abstract

Results: Of 1301 enrolled pts, w25% received NACT. At the data cutoff (30 Mar 2020) median follow-up was w20 months in both arms. There was no statistically significant PFS improvement in either the ITT population (HR 0.92 [95% CI 0.79e1.07]; median 18.4 months with pbo vs 19.5 months with atezo) or the PD-L1+ population (HR 0.80 [0.65e0.99], median 18.5 vs 20.8 months, respectively). Exploratory PFS analyses in the PD-L1 IC 5% subgroup showed a trend favouring atezo. Though immature, first interim OS results did not show significant benefit from atezo. Similar proportions discontinued any study treatment for AEs (22% pbo vs 26% atezo pts). The safety profile of atezo + bev + chemotherapy was consistent with expected AEs. Conclusions: Atezo did not significantly improve PFS in the ITT or PD-L1+ population. The combination was generally well tolerated with manageable AEs. Exploratory biomarker subgroup analyses are ongoing. Background: Recurrent or metastatic cervical cancer (r/mCC) is a global medical problem with few effective treatments, especially in the second-or third-line settings where available therapies have very limited activity. The phase 2 study innovaTV 204 was conducted to assess the potential of tisotumab vedotin, a tissue factoredirected antibodyedrug conjugate, to address this high unmet need in patients with r/mCC.