Tisotumab vedotin may reduce the risk of mortality by 30% and extend overall survival by 2 months compared with chemotherapy in patients with recurrent cervical cancer, according to a recent study. 

In a randomized, open-label, multinational phase III trial, published in The New England Journal of Medicine, researchers evaluated tisotumab vedotin as a second- or third-line therapy for recurrent or metastatic cervical cancer. The study compared tisotumab vedotin with investigator-selected chemotherapy options, including topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. The primary endpoint of the trial was overall survival (OS), with secondary endpoints including progression-free survival (PFS) and objective response rate (ORR).

A total of 502 patients were enrolled, with 253 randomly assigned to receive tisotumab vedotin (2.0 mg/kg every 3 weeks) and 249 to chemotherapy. Baseline demographics and disease characteristics were balanced between the groups. The median OS was longer with tisotumab vedotin at 11.5 months (95% confidence interval [CI] = 9.8–14.9) compared with 9.5 months (95% CI = 7.9–10.7) with chemotherapy, reflecting a 30% reduction in the risk of mortality (hazard ratio [HR] = 0.70, 95% CI = 0.54–0.89, P = .004). Median PFS was 4.2 months (95% CI = 4.0–4.4) with tisotumab vedotin vs 2.9 months (95% CI = 2.6–3.1) in the chemotherapy group (HR = 0.67, 95% CI = 0.54–0.82, P < .001). The ORR was 17.8% (95% CI = 13.3–23.1) in the tisotumab vedotin group compared with 5.2% (95% CI = 2.8–8.8) in the chemotherapy group (odds ratio = 4.0, 95% CI = 2.1–7.6, P < .001).

Adverse events were observed in nearly all patients (98.4% in the tisotumab vedotin group vs 99.2% in the chemotherapy group). Grade 3 or higher adverse events occurred in 52.0% of patients receiving tisotumab vedotin and 62.3% of those receiving chemotherapy. Treatment-related adverse events led to treatment discontinuation in 14.8% of patients in the tisotumab vedotin group.

The study results indicated that tisotumab vedotin significantly improved survival and response rates compared with chemotherapy for recurrent cervical cancer, though careful management of associated toxicities is necessary.

Full disclosures can be found in the published study.