Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Issue 8 (15th June 2022)

• Record Type: Journal Article
• Authors: Yonemori, Kan; Kuboki, Yasutoshi; Hasegawa, Kosei; Iwata, Takashi; Kato, Hidenori; Takehara, Kazuhiro; Hirashima, Yasuyuki; Kato, Hisamori; Passey, Chaitali; Buchbjerg, Jeppe Klint; Harris, Jeffrey R.; Andreassen, Camilla Mondrup; Nicacio, Leonardo; Soumaoro, Ibrahima; Fujiwara, Keiichi
• Is Part Of: Cancer science. Volume 113:Issue 8(2022)
• Page Start: 2788
• Page End: 2797
• Publication Date: 2022-06-15
• Subjects: female -- recurrence -- thromboplastin -- tisotumab vedotin -- uterine cervical neoplasms; Cancer -- Periodicals; Neoplasms -- Periodicals; Research -- Periodicals; Electronic journals; 616.994005
• DOI: 10.1111/cas.15443
• Languages: English
• ISSNs: 1347-9032

Abstract

Abstract: New treatments, particularly second‐line options, are needed to improve outcomes for patients with recurrent/metastatic cervical cancer (r/mCC). Tisotumab vedotin (TV) is an antibody–drug conjugate directed to tissue factor, a transmembrane protein commonly expressed in cancer cells, to deliver cytotoxic monomethyl auristatin E. This single‐arm, open‐label phase 1/2 trial evaluated the consistency of safety and efficacy outcomes of TV in Japanese patients with r/mCC to bridge the current findings with those reported in previous trials in non‐Japanese patients in the United States and Europe. In part 1 (dose escalation; N = 6), patients with advanced solid tumors received TV 1.5 or 2.0 mg/kg once every 3 weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 (dose expansion; N = 17) evaluated the RP2D in r/mCC patients with 1–2 prior lines of therapy. In part 1, no dose‐limiting toxicities were observed, the MTD was not reached, and TV 2.0 mg/kg was established as the RP2D. In part 2, the most common treatment‐emergent adverse events were anemia (58.8%), nausea (58.8%), alopecia (47.1%), epistaxis (47.1%), and diarrhea (35.3%); adverse events of special interest were bleeding (76.5%), ocular events (35.3%), and peripheral neuropathy (17.6%), and were mostly grade 1/2. In part 2, confirmed objective response rate was 29.4%, median duration of response was 7.1 months, and median time to response was 1.2 months. In Japanese patients with r/mCC, TV demonstrated a manageable and tolerable safety, pharmacokinetics, and efficacy profile consistent with that observed in non‐Japanese patients. Abstract : There is a need for second‐line treatments for patients with recurrent/metastatic cervical cancer (r/mCC). Tisotumab vedotin (TV), an antibody–drug conjugate, has been approved for treatment of r/mCC following a large phase 2 study in a non‐Japanese population. The current study extends the feasibility of this regimen for use in Japanese patients with r/mCC.