Related Experiment Video
Updated: Dec 17, 2025
Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung
Anne C Chiang1, Lecia Van Dam Sequist2, Jill Gilbert3
1Department of Medicine, Yale School of Medicine, Yale University, New Haven, CT.
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 And Methods:
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.
Insights
Atezolizumab demonstrated antitumor activity and was well-tolerated in patients with relapsed/refractory small-cell lung cancer (SCLC). Biomarker analysis suggested potential for improved outcomes with atezolizumab in SCLC.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Programmed death-ligand 1 (PD-L1) is expressed in various cancers, including small-cell lung cancer (SCLC).
- Atezolizumab targets PD-L1 signaling to enhance anti-tumor T-cell responses.
Purpose of the Study:
- To evaluate the safety and efficacy of atezolizumab in patients with relapsed/refractory SCLC.
- To explore biomarkers associated with antitumor activity of atezolizumab.
Main Methods:
- Phase 1, first-in-human study (PCD4989g) in patients with relapsed/refractory SCLC.
- Atezolizumab administered intravenously every 3 weeks for 16 cycles or until loss of benefit.
- Primary endpoint: safety; secondary endpoints: efficacy and biomarker assessment.
Main Results:
- Seventeen patients were enrolled; atezolizumab was generally well-tolerated.
- Treatment-related adverse events occurred in 64.7% of patients, most commonly fatigue.
- Partial responses observed per RECIST v1.1 (5.9%) and irRC (17.6%). Median PFS and OS were 1.5 and 5.9 months, respectively.
- Trends toward improved PFS and OS were noted in patients with high T-effector gene signature and PD-L1 mRNA expression.
Conclusions:
- Atezolizumab exhibits antitumor activity in relapsed/refractory SCLC.
- The drug was generally well-tolerated in this patient cohort.
- Biomarker expression may predict response to atezolizumab in SCLC.
More Related Videos
07:42Patient-Derived Tumor Explants As a "Live" Preclinical Platform for Predicting Drug Resistance in Patients
Published on: February 7, 2021
10:29Semi-automatic PD-L1 Characterization and Enumeration of Circulating Tumor Cells from Non-small Cell Lung Cancer Patients by Immunofluorescence
Published on: August 14, 2019
