Phase 1 study of pembrolizumab plus chemotherapy in Japanese patients with extensive-stage small-cell lung cancer.
Invest New Drugs
; 42(1): 136-144, 2024 Feb.
Article
en En
| MEDLINE
| ID: mdl-38300341
ABSTRACT
BACKGROUND:
Part E of the KEYNOTE-011 (NCT01840579) study assessed the safety and antitumor activity of pembrolizumab plus platinum-etoposide chemotherapy in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).METHODS:
Patients received 4 cycles of pembrolizumab (200 mg) every 3 weeks in combination with cisplatin (75 mg/m2) and etoposide (100 mg/m2; days 1, 2, 3) in cohort 1; with carboplatin (AUC 5 mg/mL/min) and etoposide (100 mg/m2; days 1, 2, 3) in cohort 2; or with cisplatin/etoposide and pegfilgrastim (3.6 mg; cycle 1, day 4) in cohort 3. Combination therapy was followed by pembrolizumab monotherapy (31 cycles). The primary endpoint was safety and tolerability (including dose-limiting toxicities; DLTs).RESULTS:
Fifteen patients were included in the study (cohort 1, n = 6; cohort 2, n = 6; cohort 3, n = 3). Median time from treatment allocation to data cutoff was 22.1 months (range, 4.1â32.4 months). DLTs occurred in 3 patients in cohort 1 (one patient with grade 4 laryngeal stenosis and grade 3 febrile neutropenia; two patients with grade 3 febrile neutropenia); no patients in cohorts 2 or 3 experienced DLTs. Grade ≥ 3 treatment-related adverse events included leukopenia (67%) and neutropenia (87%). Among all patients, ORR was 67% (95% CI, 38%â88%) and median DOR was 4.5 months (range, 2.8â28.8 months). Median PFS was 4.2 months (95% CI, 3.0â7.8 months) and median OS was 22.1 months (95% CI, 7.4â25.9 months).CONCLUSION:
Pembrolizumab in combination with platinum-etoposide therapy had manageable toxicity with no new safety signals and was associated with antitumor activity in Japanese patients with ES-SCLC. TRIAL REGISTRATION ClinicalTrials.gov , NCT01840579.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Carcinoma Pulmonar de Células Pequeñas
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Anticuerpos Monoclonales Humanizados
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Neutropenia Febril
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Neoplasias Pulmonares
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Invest New Drugs
Año:
2024
Tipo del documento:
Article
País de afiliación:
Japón