Among patients with second-/third-line recurrent or metastatic cervical cancer, tisotumab vedotin demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus chemotherapy, according to results from a global, randomized, open-label phase 3 study.

The innovaTV 301/ENGOT-cx12/GOG-3057 trial included 502 patients with recurrent or metastatic cervical cancer who experienced disease progression on or after chemotherapy doublet, with or without bevacizumab and an anti-PD-(L)1 agent (if eligible and available). Patients were randomized on a 1-to-1 basis to receive either tisotumab vedotin monotherapy (n = 253) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed; n = 249). The primary end point was OS, and key secondary endpoints included PFS and ORR. Efficacy end points were compared across pre-specified subgroups and with tissue factor expression.

The median follow-up duration was 10.8 months. The median OS in the tisotumab vedotin arm was 11.5 months vs 9.5 months in the chemotherapy arm, which correlated to a 30% reduction in risk of death ([hazard ratio] HR, 0.70; 95% CI, 0.54 to 0.89; P = .0038). The PFS was also superior in the tisotumab vedotin arm vs chemotherapy (HR, 0.67; 95% CI, 0.54 to 0.82; P < .0001). The confirmed ORR was 17.8% in the tisotumab vedotin and 5.2% in the chemotherapy arm (odds ratio, 4.0; 95% CI, 2.1 to 7.6; P < .0001). The efficacy end points of OS, PFS, and ORR favored the tisotumab vedotin arm in key pre-specified subgroups, which included patients with prior anti-PD-(L)1 exposure, and were consistent with the overall treatment effect. Adverse events were consistent with the known tisotumab vedotin safety profile, including ocular events, peripheral neuropathy, and bleeding.

Brian M. Slomovitz, MD, Mount Sinai Medical Center, Miami Beach, Florida, and coauthors concluded, “[tisotumab vedotin] showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR versus chemotherapy that was consistent across key prespecified subgroups and the intent-to-treat population, regardless of [tissue factor] expression.”

Source:

Slomovitz B, González-Martín A, Fujiwara K, et al. Efficacy and safety of tisotumab vedotin versus investigator's choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer (innovaTV 301/ENGOT-cx12/GOG-3057): A global, randomized, open-label, phase III study. Presented at the Society of Gynecologic Oncology Annual Meeting. March 16-18, 2024; San Diego, California.