Tisotumab vedotin improves recurrent and metastatic cervical cancer survival

medwireNews: Women with recurrent or metastatic cervical cancer gain a significant overall survival (OS) advantage from second- or third-line treatment with tisotumab vedotin (TV) rather than chemotherapy, report phase 3 trial investigators. Presenting the findings on behalf of his colleagues at the ESMO Congress 2023, Ignace Vergote (University Hospitals Leuven, Belgium) said that TV was associated with a clinically meaningful 30% reduction in the risk for death. He told the audience in Madrid, Spain, that the safety profile of the tissue factor-directed antibody–drug conjugate “was manageable and tolerable, and consistent with our previous experience.” Vergote continued: “Based on these data, I believe that tisotumab vedotin should be considered as a potential new standard of care for patients who have progressed after first-line systemic therapy.” Discussant Krishnansu Tewari (University of California, Irvine, USA) agrees that “this is a practice changing study,” that “is going to convert the accelerated approval of TV [for this indication] in the United States to full approval and importantly, is going to introduce a brand new cervical cancer medicine to Europe.” A total of 502 patients who had received up to two prior lines of therapy for recurrent or metastatic cervical cancer were enrolled in the innovaTV 301/ENGOT-cx12/GOG-3057 trial. Participants needed to have progressed on or after standard of care doublet chemotherapy, and to have received bevacizumab and an anti-PD-(L)1 agent if they were eligible and the options were available. The randomized trial pitted TV, given intravenously at a dose of 2 mg/kg every 3 weeks, against investigator's choice of single-agent topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. After a median follow-up of 10.8 months, the primary endpoint of OS was significantly improved with TV relative to chemotherapy, at a median of 11.5 versus 9.5 months, and a hazard ratio (HR) for death of 0.70. The 12-month OS rates were 48.7% and 35.3%, respectively. Treatment with TV also resulted in a significantly longer progression-free survival and higher objective response rate than chemotherapy, at median durations of 4.2 versus 2.9 months (HR=0.67) and rates of 17.8% versus 5.2%, respectively. Although the incidence of any-grade treatment related adverse events (TRAEs) was similar between the TV and chemotherapy groups (87.6 vs 85.4%), there were fewer events of grade 3 or worse in the former group, at 29.2% versus 45.2%. Conjunctivitis was the most common TRAE of any grade among TV-treated patients, observed in 30.4%, followed by nausea, peripheral sensory neuropathy, alopecia, and epistaxis, in a respective 29.2%, 26.8%, 24.4%, and 22.8% of patients. By contrast, the most frequent TRAEs in the chemotherapy group were anemia, nausea, and neutropenia, in 43.9%, 36.0%, and 21.8%, respectively. Two patients in the TV arm had a grade 5 TRAE, one case each of acute kidney injury and Stevens–Johnson syndrome, as did one patient in the chemotherapy arm, a case of pancytopenia. Ocular events, peripheral neuropathy, and bleeding were AEs of special interest for TV, occurring in 47.2%, 30.4%, and 26.8% of patients, respectively. But the presenter highlighted that the cases were largely of grade 1 or 2, with grade 3 events reported in a corresponding 3.2%, 5.2%, and 0.8%. There were no grade 4 or 5 AEs of special interest. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group ESMO Congress 2023; Madrid, Spain: 20–24 October

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Tisotumab vedotin improves recurrent and metastatic cervical cancer survival

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Keynote webinar | Spotlight on antibody–drug conjugates in cancer