Japanese journal of clinical oncology · 2026
Cemiplimab in Japanese patients with advanced non-small cell lung cancer.
Клиническое исследование I фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Sato Yuki, Tani Yoko, Ishii Hidenobu, Katakura Seigo, Oki Masahide, Watanabe Yasutaka, Yokoyama Toshihide, Naoki Katsuhiko, Pouliot Jean-Francois, Kaul Manika, Paccaly Anne, Visich Jennifer E, Kim Eric, Mani Jayakumar, Li Yuntong, Lowy Israel, Seebach Frank, Mathias Melissa, Ikeda Satoshi
Аннотация
BACKGROUND: EMPOWER-Lung 1 and EMPOWER-Lung 3 (phase 3 studies) demonstrated survival benefits for cemiplimab with/without chemotherapy in global (non-Japanese) patients with advanced non-small cell lung cancer (aNSCLC). This single-arm dose-expansion study assessed safety, tolerability, pharmacokinetics, and efficacy of first-line cemiplimab (350 mg intravenous every 3 weeks) as monotherapy/with chemotherapy in Japanese patients with aNSCLC.
METHODS: The primary objectives were safety, tolerability, and pharmacokinetics of cemiplimab as monotherapy/with chemotherapy. Secondary objectives included immunogenicity, tumor response (objective response rate [ORR], and duration of response [DOR]). Patients whose tumors expressed programmed cell death-ligand 1 (PD-L1) ≥50% on tumor cells received cemiplimab monotherapy (Cohort A; n = 60, safety; n = 50, efficacy). Patients whose tumors expressed any level of PD-L1 received cemiplimab plus four cycles of chemotherapy (Cohort C; n = 50).
RESULTS: Safety results were generally consistent with the known safety profile of cemiplimab. Treatment-emergent adverse events (grade ≥3) were experienced by 51.7% (31/60) in patients receiving cemiplimab monotherapy (Cohort A) and 68.0% (34/50) in those receiving cemiplimab + chemotherapy (Cohort C). Pharmacokinetic results were similar across both cohorts. In Cohort A patients with centrally confirmed PD-L1 ≥50%, ORR was 60.0% (30/50) with an observed DOR of 2.1-42.5 months. In Cohort C, ORR was 42.0% (21/50) with an observed DOR of 2.3-20.7 months. Immunogenicity was low in both cohorts.
CONCLUSION: Cemiplimab demonstrated efficacy in Japanese patients as monotherapy for PD-L1 ≥50% and with chemotherapy irrespective of PD-L1 expression. Overall, cemiplimab demonstrated a favorable benefit-risk profile in Japanese patients.
METHODS: The primary objectives were safety, tolerability, and pharmacokinetics of cemiplimab as monotherapy/with chemotherapy. Secondary objectives included immunogenicity, tumor response (objective response rate [ORR], and duration of response [DOR]). Patients whose tumors expressed programmed cell death-ligand 1 (PD-L1) ≥50% on tumor cells received cemiplimab monotherapy (Cohort A; n = 60, safety; n = 50, efficacy). Patients whose tumors expressed any level of PD-L1 received cemiplimab plus four cycles of chemotherapy (Cohort C; n = 50).
RESULTS: Safety results were generally consistent with the known safety profile of cemiplimab. Treatment-emergent adverse events (grade ≥3) were experienced by 51.7% (31/60) in patients receiving cemiplimab monotherapy (Cohort A) and 68.0% (34/50) in those receiving cemiplimab + chemotherapy (Cohort C). Pharmacokinetic results were similar across both cohorts. In Cohort A patients with centrally confirmed PD-L1 ≥50%, ORR was 60.0% (30/50) with an observed DOR of 2.1-42.5 months. In Cohort C, ORR was 42.0% (21/50) with an observed DOR of 2.3-20.7 months. Immunogenicity was low in both cohorts.
CONCLUSION: Cemiplimab demonstrated efficacy in Japanese patients as monotherapy for PD-L1 ≥50% and with chemotherapy irrespective of PD-L1 expression. Overall, cemiplimab demonstrated a favorable benefit-risk profile in Japanese patients.