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Tisotumab vedotin is more effective than chemotherapy for patients with recurrent or metastatic cervical cancer, according to data presented at the ESMO Congress 2023.
Tisotumab vedotin improved response rates, progression-free survival (PFS), and overall survival (OS) in this phase 3 study.
These results suggest that tisotumab vedotin “should be considered as a potential new standard of care for patients who have progressed after first-line systemic therapy,” said study presenter Ignace B. Vergote, MD, PhD, of UZ Leuven in Belgium.
Dr Vergote and colleagues tested tisotumab vedotin in the phase 3 innovaTV 301 trial (ClinicalTrials.gov Identifier: NCT04697628). The trial enrolled 502 patients with recurrent or metastatic cervical cancer who had received up to 2 lines of prior therapy. Eligible patients needed to have disease progression during or after a chemotherapy doublet, with or without bevacizumab and anti-PD-1/PD-L1 therapy.
The patients were randomly assigned to receive tisotumab vedotin (n=253) or investigator’s choice of chemotherapy (n=249). Tisotumab vedotin was given at 2.0 mg/kg every 3 weeks. Chemotherapy could consist of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.
At a median follow-up of 10.8 months, the median OS was 11.5 months in the tisotumab vedotin arm and 9.5 months in the chemotherapy arm (hazard ratio [HR], 0.70; 95% CI, 0.54-0.89; P =.0038). The 12-month OS rate was 48.7% in the tisotumab vedotin arm and 35.3% in the chemotherapy arm.
The median PFS was 4.2 months in the tisotumab vedotin arm and 2.9 months in the chemotherapy arm (HR, 0.67; 95% CI, 0.54-0.82; P <.0001). The 6-month PFS rate was 30.4% in the tisotumab vedotin arm and 18.9% in the chemotherapy arm.
The objective response rate was 17.8% in the tisotumab vedotin arm and 5.2% in the chemotherapy arm (odds ratio, 4.0; 95% CI, 2.1-7.6; P <.0001). The median duration of response was 5.3 months in the tisotumab vedotin arm and 5.7 months in the chemotherapy arm.
Treatment-related adverse events (TRAEs) were reported in 87.6% of patients in the tisotumab vedotin arm and 85.4% of patients in the chemotherapy arm. The rate of grade 3 or higher TRAEs was 29.2% and 45.2%, respectively.
Fatal TRAEs were reported in 2 patients in the tisotumab vedotin arm (acute kidney injury and Stevens-Johnson syndrome) and 1 patient in the chemotherapy arm (pancytopenia).
Disclosures: This research was supported by Genmab and Seagen Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Vergote IB, Gonzalez Martin A, Fujiwara K, et al. innovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer. Presented at ESMO Congress 2023. Oct 20-24, 2023. Madrid, Spain. Abstract LBA9.
This article originally appeared on Cancer Therapy Advisor
