PD-1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study.
In: Cancer medicine, Jg. 13 (2024-04-01), Heft 8, S. e6980
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Zugriff:
Background: Retifanlimab is a humanized monoclonal antibody targeting programmed death protein-1, and INCB001158 is an oral arginase inhibitor. This phase Ib study investigated retifanlimab, INCB001158, and their combination in Japanese patients with advanced solid tumors.
Methods: Patients received retifanlimab (500 mg every 4 weeks [Q4W] i.v.) or escalating doses of INCB001158 (75 or 100 mg twice daily [BID]) monotherapy in Part 1 and combination of retifanlimab (500 mg Q4W) and INCB001158 (100 mg BID) in Part 2. Primary endpoints were safety, tolerability, dose-limiting toxicities (DLTs), and determination of recommended phase II doses in Japanese patients.
Results: Eighteen patients (retifanlimab or INCB001158 monotherapy and combination; n = 6 each) were enrolled at 2 sites in Japan. There were no DLTs, fatal adverse events (AEs), or discontinuations due to AEs. Rash (all grade 1) was the most common treatment-emergent AE with retifanlimab (n = 6). Treatment-related AEs were reported with retifanlimab (n = 4) or INCB001158 (n = 2) monotherapy and with combination (n = 4); an immune-related AE (thyroid disorder, grade 2) was reported with combination. Two responses were observed with retifanlimab monotherapy (1 complete, 1 partial) and 1 stable disease (SD), for an overall response rate of 33.3% (95% confidence interval [CI], 4.3-77.7) and disease control rate (DCR) of 50% (95% CI, 11.8-88.2). Three patients had SD with INCB001158 monotherapy (DCR 50%; 95% CI, 11.8-88.2). No responses or SD were observed with combination therapy.
Conclusion: Retifanlimab, INCB001158, and their combination had acceptable safety profiles. Promising retifanlimab antitumor activity warrants further investigation in Japanese patients.
(© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
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PD-1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study.
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Autor/in / Beteiligte Person: | Kuboki, Y ; Koyama, T ; Matsubara, N ; Naito, Y ; Kondo, S ; Harano, K ; Yonemori, K ; Yoh, K ; Gu, Y ; Mita, T ; Chen, X ; Ueda, E ; Yamamoto, N ; Doi, T ; Shimizu, T |
Zeitschrift: | Cancer medicine, Jg. 13 (2024-04-01), Heft 8, S. e6980 |
Veröffentlichung: | [Malden, MA] : John Wiley & Sons Ltd., c2012-, 2024 |
Medientyp: | academicJournal |
ISSN: | 2045-7634 (electronic) |
DOI: | 10.1002/cam4.6980 |
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