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- Title
Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies.
- Authors
Kitano, Shigehisa; Shimizu, Toshio; Koyama, Takafumi; Ebata, Takahiro; Iwasa, Satoru; Kondo, Shunsuke; Shimomura, Akihiko; Fujiwara, Yutaka; Yamamoto, Noboru; Paccaly, Anne; Li, Siyu; Rietschel, Petra; Sims, Tasha
- Abstract
<bold>Purpose: </bold>Part 1 of this two-part, open-label, Phase 1 study (NCT03233139) assessed the safety, tolerability, pharmacokinetics, immunogenicity, and clinical activity of cemiplimab in Japanese patients with advanced malignancies.<bold>Methods: </bold>Patients received cemiplimab 250 mg (n = 6) or 350 mg (n = 7) every 3 weeks intravenously for up to 108 weeks in Part 1. Tumor responses were assessed by investigators every 9 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1.<bold>Results: </bold>Of 13 patients enrolled, median age was 62 years (range 33-75) and eight patients were female. Median duration of cemiplimab exposure was 13.1 weeks (range 3.0‒113.6). At the time of data cut-off, 11 patients (84.6%) had discontinued treatment (majority due to disease progression: n = 8, 61.5%). The most common treatment-emergent adverse events (TEAEs) of any grade were contact dermatitis, rash, and viral upper respiratory tract infection (each n = 3, 23.1%). Five grade ≥ 3 TEAEs were reported in four patients: autoimmune colitis, dehydration, hyponatremia, hypophosphatemia, and muscular weakness. No dose-limiting toxicities were reported and no TEAEs led to death. Cemiplimab concentrations in serum were consistent with previously reported pharmacokinetic characteristics of cemiplimab. No anti-drug antibodies were detected in serum. Objective response rate [ORR; complete response + partial response (PR)] was 30.8% (four PR) and disease control rate [ORR + stable disease (SD)] was 46.2% (6/13; two SD).<bold>Conclusion: </bold>Cemiplimab exhibited antitumor activity in Japanese patients with advanced malignancies. The safety profile was comparable to those previously reported for cemiplimab and other PD-1 inhibitors.<bold>Trial Registration: </bold>NCT03233139 at ClinicalTrials.gov.
- Subjects
JAPAN; JAPANESE people; RESPIRATORY infections; MONOCLONAL antibodies; CONTACT dermatitis; CEMIPLIMAB; DISEASE progression; RESEARCH; INTRAVENOUS therapy; CLINICAL trials; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; DOSE-effect relationship in pharmacology; TUMORS
- Publication
Cancer Chemotherapy & Pharmacology, 2021, Vol 87, Issue 1, p53
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-020-04161-6