In this phase I study (NCT03070990), Japanese patients with locally advanced/metastatic urothelial cancer treated with prior chemotherapy, or ineligible for cisplatin, were randomized 1:1 to receive 1.0 mg/kg (Arm A) or 1.25 mg/kg (Arm B) enfortumab vedotin on Days 1, 8, and 15 of each 28-day cycle. Assessing the pharmacokinetic and safety/tolerability profiles of enfortumab vedotin were primary objectives; investigator-assessed antitumor activity (RECIST v1.1) was a secondary objective. Seventeen patients (n = 9, Arm A; n = 8, Arm B) received treatment. Pharmacokinetic data suggest a dose-dependent increase in enfortumab vedotin maximum concentration and area under the concentration–time curve at Day 7.
Enfortumab vedotin was well tolerated across both doses. Dysgeusia and alopecia (n = 9 each) were the most common treatment-related adverse events. Regardless of attribution, grade ≥ 3 adverse events occurring in ≥2 patients were anemia and hypertension (n = 2 each). One patient achieved a confirmed complete response (Arm A) and five achieved confirmed partial responses (n = 3, Arm A; n = 2, Arm B). Objective response and disease control rates were 35.3% and 76.5%, respectively. In Japanese patients with locally advanced/metastatic urothelial cancer, enfortumab vedotin is well tolerated with preliminary antitumor activity and a pharmacokinetic profile consistent with prior reports.
Shunji Takahashi1 & Motohide Uemura2 & Tomokazu Kimura3 & Yoshihide Kawasaki4 & Atsushi Takamoto5 & Akito Yamaguchi6 & Amal Melhem-Bertrandt7 & Elaina M. Gartner8 & Takashi Inoue9 & Rio Akazawa9 & Takeshi Kadokura9 & Toshiki Tanikawa10
- Department of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
- Osaka University Hospital, Osaka, Japan
- University of Tsukuba Hospital, Tsukuba, Japan
- Tohoku University Hospital, Sendai, Japan
- Okayama University Hospital, Okayama, Japan
- Harasanshin Hospital, Fukuoka, Japan
- Astellas Pharma Global Development, Northbrook, IL, USA
- Seattle Genetics, Seattle, WA, USA
- Astellas Pharma, Inc., Tokyo, Japan
- Niigata Cancer Center Hospital, Niigata, Japan