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Vergote, Ignace; Van Nieuwenhuysen, Els; O'Cearbhaill, Roisin E; Westermann, Anneke; Lorusso, Domenica; Ghamande, Sharad; Collins, Dearbhaile C; Banerjee, Susana; Mathews, Cara A; Gennigens, Christine; Cibula, David; Tewari, Krishnansu S; Madsen, Kristine; Köse, Fatih; Jackson, Amanda L; Boere, Ingrid A; Scambia, Giovanni; Randall, Leslie M; Sadozye, Azmat; Baurain, Jean-François; Gort, Eelke; Zikán, Michal; Denys, Hannelore G; Ottevanger, Nelleke; Forget, Frédéric; Mondrup Andreassen, Camilla; Eaton, Lamar; Chisamore, Michael J; Viana Nicacio, Leonardo; Soumaoro, Ibrahima; Monk, Bradley J
Journal of clinical oncology, 12/2023, Volume: 41, Issue: 36Journal Article
Tissue factor is highly expressed in cervical carcinoma and can be targeted by tisotumab vedotin (TV), an antibody-drug conjugate. This phase Ib/II study evaluated TV in combination with bevacizumab, pembrolizumab, or carboplatin for recurrent or metastatic cervical cancer (r/mCC). This open-label, multicenter study (ClinicalTrials.gov identifier: NCT03786081) included dose-escalation arms that assessed dose-limiting toxicities (DLTs) and identified the recommended phase II dose (RP2D) of TV in combination with bevacizumab (arm A), pembrolizumab (arm B), or carboplatin (arm C). The dose-expansion arms evaluated TV antitumor activity and safety at RP2D in combination with carboplatin as first-line (1L) treatment (arm D) or with pembrolizumab as 1L (arm E) or second-/third-line (2L/3L) treatment (arm F). The primary end point of dose expansion was objective response rate (ORR). A total of 142 patients were enrolled. In dose escalation (n = 41), no DLTs were observed; the RP2D was TV 2 mg/kg plus bevacizumab 15 mg/kg on day 1 once every 3 weeks, pembrolizumab 200 mg on day 1 once every 3 weeks, or carboplatin AUC 5 on day 1 once every 3 weeks. In dose expansion (n = 101), the ORR was 54.5% (n/N, 18/33; 95% CI, 36.4 to 71.9) with 1L TV + carboplatin (arm D), 40.6% (n/N, 13/32; 95% CI, 23.7 to 59.4) with 1L TV + pembrolizumab (arm E), and 35.3% (12/34; 19.7 to 53.5) with 2L/3L TV + pembrolizumab (arm F). The median duration of response was 8.6 months, not reached, and 14.1 months, in arms D, E, and F, respectively. Grade ≥3 adverse events (≥15%) were anemia, diarrhea, nausea, and thrombocytopenia in arm D and anemia in arm F (none ≥15%, arm E). TV in combination with bevacizumab, carboplatin, or pembrolizumab demonstrated manageable safety and encouraging antitumor activity in treatment-naive and previously treated r/mCC.
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