Tisotumab

Tisotumab vedotin is simpler than chemotherapy for sufferers with recurrent or metastatic cervical most cancers, in accordance with knowledge offered on the ESMO Congress 2023.

Tisotumab vedotin improved response charges, progression-free survival (PFS), and total survival (OS) on this section 3 examine.

These outcomes recommend that tisotumab vedotin “needs to be thought-about as a possible new commonplace of take care of sufferers who’ve progressed after first-line systemic remedy,” mentioned examine presenter Ignace B. Vergote, MD, PhD, of UZ Leuven in Belgium.

Proceed Studying

Dr Vergote and colleagues examined tisotumab vedotin within the section 3 innovaTV 301 trial (ClinicalTrials.gov Identifier: NCT04697628). The trial enrolled 502 sufferers with recurrent or metastatic cervical most cancers who had acquired as much as 2 strains of prior remedy. Eligible sufferers wanted to have illness development throughout or after a chemotherapy doublet, with or with out bevacizumab and anti-PD-1/PD-L1 remedy.

The sufferers have been randomly assigned to obtain tisotumab vedotin (n=253) or investigator’s selection of chemotherapy (n=249). Tisotumab vedotin was given at 2.0 mg/kg each 3 weeks. Chemotherapy may encompass topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.

At a median follow-up of 10.8 months, the median OS was 11.5 months within the tisotumab vedotin arm and 9.5 months within the chemotherapy arm (hazard ratio [HR], 0.70; 95% CI, 0.54-0.89; P =.0038). The 12-month OS charge was 48.7% within the tisotumab vedotin arm and 35.3% within the chemotherapy arm.

The median PFS was 4.2 months within the tisotumab vedotin arm and a couple of.9 months within the chemotherapy arm (HR, 0.67; 95% CI, 0.54-0.82; P <.0001). The 6-month PFS charge was 30.4% within the tisotumab vedotin arm and 18.9% within the chemotherapy arm.

The target response charge was 17.8% within the tisotumab vedotin arm and 5.2% within the chemotherapy arm (odds ratio, 4.0; 95% CI, 2.1-7.6; P <.0001). The median period of response was 5.3 months within the tisotumab vedotin arm and 5.7 months within the chemotherapy arm.

Remedy-related antagonistic occasions (TRAEs) have been reported in 87.6% of sufferers within the tisotumab vedotin arm and 85.4% of sufferers within the chemotherapy arm. The speed of grade 3 or increased TRAEs was 29.2% and 45.2%, respectively.

Deadly TRAEs have been reported in 2 sufferers within the tisotumab vedotin arm (acute kidney harm and Stevens-Johnson syndrome) and 1 affected person within the chemotherapy arm (pancytopenia).

Disclosures: This analysis was supported by Genmab and Seagen Inc. Some examine authors declared affiliations with biotech, pharmaceutical, and/or system firms. Please see the unique reference for a full record of disclosures.