학술논문
Long-term follow-up results from KEYNOTE-041: Phase 1b study of pembrolizumab in Japanese patients with advanced melanoma.
Document Type
Academic Journal
Author
Yokota K; Department of Dermatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Takenouchi T; Department of Dermatology, Niigata Cancer Center Hospital, Niigata, Japan.; Fujisawa Y; Department of Dermatology, Faculty of Medicine, Ehime University, Ehime, Japan.; Fukushima S; Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.; Uchi H; Department of Dermatologic Oncology, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan.; Inozume T; Chiba University, Chiba, Japan.; Kiyohara Y; Division of Dermatology, Shizuoka Cancer Center Hospital, Shizuoka, Japan.; Uhara H; Department of Dermatology, Sapporo Medical University, School of Medicine, Sapporo, Hokkaido, Japan.; Nakagawa K; Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.; Furukawa H; Department of Plastic and Reconstructive Surgery, Aichi Medical University Hospital, Nagakute, Aichi, Japan.; Han S; MSD K.K, Tokyo, Japan.; Watanabe M; MSD K.K, Tokyo, Japan.; Noguchi K; MSD K.K, Tokyo, Japan.; Yamazaki N; Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Source
Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7600545 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1346-8138 (Electronic) Linking ISSN: 03852407 NLM ISO Abbreviation: J Dermatol Subsets: MEDLINE
Subject
Language
English
Abstract
Pembrolizumab demonstrated an acceptable safety profile and promising antitumor activity in Japanese patients with advanced melanoma in the phase 1b KEYNOTE-041 (Study of Pembrolizumab [MK-3475] in Participants With Advanced Melanoma) trial. To evaluate the long-term efficacy and safety of pembrolizumab in Japanese patients with advanced melanoma in KEYNOTE-041. The current analysis reports results of additional follow-up of approximately 12 months since the initial analysis. Eligible patients had locally advanced (unresectable stage III) or metastatic (stage IV) melanoma not amenable to local therapy and had received two or fewer prior systemic therapies. Pembrolizumab 2 mg/kg was given every 3 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Primary end points included safety, tolerability, and overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 by independent central review. The data cutoff for this analysis was August 30, 2017. Forty-two patients were followed up for a median of 22.3 months (range, 2.63-30.82 months). The ORR was 24.3% (nine of 37 evaluable patients [95% confidence interval (CI), 11.8%-41.2%]). Two patients with partial response at the time of the initial analysis achieved complete response. The median overall survival (OS) was 25.1 months (95% CI, 13.1-not reached] and the 30-month OS rate was 46.3% (95% CI, 29.8%-61.3%). The median duration of response was not reached. Treatment-related adverse events (TRAEs) were reported in 78.6% of patients; the incidence of grade 3 to 5 TRAEs was 23.8%. No additional treatment-related deaths occurred since the initial analysis. Pembrolizumab provided durable antitumor activity and an acceptable safety profile in Japanese patients with advanced melanoma.
(© 2024 MSD K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)
(© 2024 MSD K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)