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Sintilimab plus docetaxel as second-line therapy of advanced non-small cell lung cancer without targetable mutations:
Yongchang Zhang1,2, Lianxi Song3,4,5, Liang Zeng3,4
1Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410013, China. zhangyongchang@csu.edu.cn.
Background:
Single-agent immunotherapy is currently the recommended second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) without targetable mutations; however, the objective response rate (ORR) remains low. This phase II study evaluated the efficacy of the combination therapy of sintilimab plus docetaxel and explored potential biomarkers for efficacy prediction.
Methods:
Thirty patients with NSCLC without targetable mutations whose disease progressed from first-line platinum-based chemotherapy from October 2019 to December 2020 were enrolled in this single-arm, single-center, phase II trial. Sintilimab (200 mg) and docetaxel (75 mg/m2) were administered every 3 weeks until progression. The primary endpoint was ORR. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Biomarker analyses of blood and tissue samples were also performed.
Results:
Among 30 patients, 11 patients had partial response, resulting in an ORR of 36.7%. The median PFS was 5.0 months (95%CI: 3.9-6.1) and OS was 13.4 months (95%CI: 5.6-21.2). The most common immune-related adverse event of any grade was hepatitis, observed in 23.3% (7/30) of patients. Treatment-emergent adverse events were manageable. Patients detected with high PD-L1 expression in circulating tumor cells (cutoff value ≥32.5% based on the median CTC-PD-L1 expression) achieved significantly higher ORR (60% versus 13.3%, p = 0.021) and significantly longer median PFS (6.0 versus 3.5 months, p = 0.011) and median OS (15.8 versus 9.0 months, p = 0.038) than those with low CTC-PD-L1 level. Patients detected with PD-L1 < 1% and CD8 ≥ 1% expression from their baseline tissue samples had significantly higher ORR (83.3% versus 12.5%, p = 0.026) but similar PFS (p = 0.62) and OS (p = 0.15).
Conclusion:
This study demonstrated the effectiveness and safety of sintilimab plus docetaxel as a second-line treatment of NSCLC without targetable mutations after progression from first-line platinum-based chemotherapy.
Trial Registration:
This study was registered in the Clinical trials registry with ClinicalTrials.gov Identifier NCT03798743 (SUCCESS).
Insights
Sintilimab plus docetaxel showed effectiveness as a second-line treatment for advanced non-small cell lung cancer (NSCLC) without targetable mutations. Biomarker analysis revealed PD-L1 expression in circulating tumor cells could predict treatment efficacy.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Single-agent immunotherapy offers limited objective response rates (ORR) in advanced non-small cell lung cancer (NSCLC) without targetable mutations as second-line therapy.
- This study investigated the efficacy of sintilimab combined with docetaxel in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of sintilimab plus docetaxel as second-line treatment for advanced NSCLC.
- To identify potential biomarkers for predicting treatment response.
Main Methods:
- A single-arm, phase II trial enrolled 30 NSCLC patients progressing after first-line platinum-based chemotherapy.
- Patients received sintilimab (200 mg) and docetaxel (75 mg/m²) every 3 weeks.
- Biomarker analyses included PD-L1 expression in circulating tumor cells (CTCs) and tissue samples.
Main Results:
- The overall objective response rate (ORR) was 36.7% (11/30 patients).
- Median progression-free survival (PFS) was 5.0 months, and median overall survival (OS) was 13.4 months.
- High CTC PD-L1 expression (≥32.5%) correlated with significantly higher ORR, PFS, and OS. Specific baseline tissue expression (PD-L1 <1% and CD8 ≥1%) also predicted higher ORR.
Conclusions:
- Sintilimab plus docetaxel is an effective and safe second-line treatment option for NSCLC patients without targetable mutations.
- Circulating tumor cell PD-L1 expression serves as a potential predictive biomarker for treatment efficacy.
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