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Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies

Minami, Hironobu, Doi, Toshihiko, Toyoda, Masanori, Imamura, Yoshinori, Kiyota, Naomi, Mitsuma, Awake, Shimokata, Tomoya, Naito, Yoichi, Matsubara, Nobuaki, TAJIMA, TAKESHI, TOKUSHIGE, KOTA, ISHIHARA, KAE, Cameron, Scott and Ando, Yuichi (2020) Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Cancer Science, 00. pp. 1-9. ISSN 13497006


Spartalizumab is a humanized IgG4/κ mAb directed against human programmed cell death-1 (PD-1). In this phase I study, we investigated safety, pharmacokinetics, preliminary antitumor activity, and toxicity of spartalizumab in patients with advanced malignancies. Patients (n = 18) with a range of tumor types received spartalizumab i.v. at doses of 1, 3, and 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or discontinuation at the discretion of the investigator or patient. Most patients (61%) had received five or more prior lines of therapy. No dose-limiting toxicities were reported and, hence, the maximum tolerated dose was 10 mg/kg or more. Pharmacokinetics in Japanese patients aligned with those reported in a global dose-escalation study. The safety profile was consistent with other approved anti-PD-1 mAbs; the most common drug-related adverse events were maculopapular rash (22%), followed by malaise and increased blood alkaline phosphatase (11% each). Partial responses were reported in two patients (11%), one with transitional cell carcinoma and the other with hepatocellular carcinoma. In conclusion, this study confirmed the safety of spartalizumab given at a dose of up to 10 mg/kg every 2 weeks in Japanese patients with cancers.

Item Type: Article
Keywords: clinical trial humanized monoclonal antibody immunotherapy Japan maximum tolerated dose
Date Deposited: 16 Jan 2021 00:45
Last Modified: 16 Jan 2021 00:45


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