ArticleJapanese journal of clinical oncology2026
Cemiplimab in Japanese patients with advanced non-small cell lung cancer.
Article in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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19 authors.
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Abstract
backgroundEMPOWER-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.
methodsThe 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).
resultsSafety 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.
conclusionCemiplimab 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.
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