• Ignace Vergote, Antonio González-Martín, Keiichi Fujiwara, Elsa Kalbacher, Andrea Bagaméri, Sharad Ghamande, Jung-Yun Lee, Susana Banerjee, Fernando Cotait Maluf, Domenica Lorusso, Kan Yonemori, Els Van Nieuwenhuysen, Luis Manso, Linn Woelber, Anneke Westermann, Allan Covens, Kosei Hasegawa, Byoung-Gie Kim, Miriam Raimondo, Maria Bjurberg, Felipe Melo Cruz, Antoine Angelergues, David Cibula, Lisa Barraclough, Ana Oaknin, Christine Gennigens, Leo Nicacio, Melinda Siew Leng Teng, Elizabeth Whalley, Ibrahima Soumaoro, Brian M Slomovitz, and innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators.
• From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital Universitario 12 de Octubre (L.M.), and Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M.), Madrid, and Gynecologic Cancer Program, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.O.) - all in Spain; Saitama Medical School International Medical Center, Saitama (K.F., K.H.), and the National Cancer Center Hospital, Tokyo (K.Y.) - both in Japan; Centre Hospitalier Universitaire de Besançon, Besançon (E.K.), and GINECO (E.K., A.A.) and Groupe Hospitalier Diaconesses Croix Saint-Simon (A.A.), Paris - all in France; Országos Onkológiai Intézet, Budapest, Hungary (A.B.); Georgia Cancer Center, Augusta University, Augusta (S.G.); Yonsei University College of Medicine (J.-Y.L.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.) - both in Seoul, South Korea; the Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London (S.B.), and the Christie NHS Foundation Trust, Clinical Oncology, Manchester (L.B.) - both in the United Kingdom; Hospital Beneficencia Portuguesa de São Paulo (F.C.M.), Hospital Israelita Albert Einstein de São Paulo (F.C.M.), and Instituto Brasileiro de Controle do Câncer (F.M.C.) - all in Sao Paulo; Fondazione Policlinico Gemelli IRCCS and Catholic University of Sacred Heart, Rome (D.L.); Arbeitsgemeinschaft Gynäkologische Onkologie Study Group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany (L.W.); Amsterdam University Medical Centers, Amsterdam (A.W.); Sunnybrook Research Institute, Toronto (A.C.); Medica Oncólogia Clinica en Grupo Gamma, Rosario, Argentina (M.R.); Skåne University Hospital and Lund University, Lund, Sweden (M.B.); First Faculty of Medicine, Charles University, General University Hospital in Prague, Prague, Czech Republic (D.C.); Pfizer, Bothell, WA (L.N., M.S.L.T., E.W.); Genmab US, Princeton, NJ (I.S.); and Mount Sinai Medical Center, Miami Beach, FL (B.M.S.).
• N. Engl. J. Med. 2024 Jul 4; 391 (1): 445544-55.

BackgroundRecurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy.MethodsWe conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival.ResultsA total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects.ConclusionsIn patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).Copyright © 2024 Massachusetts Medical Society.

28 keywords...

hide…