Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer.
Clin Lung Cancer
; 21(5): 455-463.e4, 2020 09.
Article
in En
| MEDLINE
| ID: mdl-32586767
ABSTRACT
BACKGROUND:
Programmed death-ligand 1 (PD-L1) protein is expressed in various cancers, including small-cell lung cancer (SCLC). Atezolizumab inhibits PD-L1 signaling, thus restoring tumor-specific T-cell immunity. Here, we report results from the first-in-human phase 1 PCD4989g study (NCT01375842) of atezolizumab, in a cohort of patients with relapsed/refractory SCLC. PATIENTS ANDMETHODS:
Eligible patients with incurable or metastatic SCLC, which was advanced or recurrent since the last antitumor therapy, received atezolizumab 15 mg/kg or 1200 mg intravenously every 3 weeks for 16 cycles or until loss of clinical benefit. The primary endpoint was safety. Efficacy and biomarkers of antitumor activity were also assessed.RESULTS:
Seventeen patients were enrolled. Any-grade and grade ≥3 treatment-related adverse events (TRAEs) occurred in 11 (64.7%) and 5 (29.4%) patients, respectively. The most common any-grade TRAE was fatigue (4 patients [23.5%]). Partial response to atezolizumab was achieved in 1 patient (5.9%) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and 3 (17.6%) per immune-related response criteria (irRC). Durations of response were 2.8 to > 45.7 months. Median investigator-assessed progression-free survival (PFS) per RECIST v1.1 and irRC was 1.5 (95% confidence interval [CI], 1.2-2.7) and 2.9 (95% CI, 1.2-6.1) months, respectively. Median overall survival (OS) was 5.9 months (95% CI, 4.3-12.6). Patients with high (≥ median expression) T-effector gene signature and PD-L1 mRNA expression appeared to show a trend toward improved PFS (per irRC) and OS.CONCLUSION:
Atezolizumab was generally well tolerated and exhibited antitumor activity in a small cohort of patients with relapsed/refractory SCLC.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Salvage Therapy
/
Drug Resistance, Neoplasm
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Small Cell Lung Carcinoma
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Antibodies, Monoclonal, Humanized
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Lung Neoplasms
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Neoplasm Recurrence, Local
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Antineoplastic Agents
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Adult
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Aged
/
Aged80
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Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Clin Lung Cancer
Journal subject:
NEOPLASIAS
Year:
2020
Document type:
Article