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. 2025 Oct 8:15:1657282.
doi: 10.3389/fonc.2025.1657282. eCollection 2025.

The effect of tislelizumab on complete and pathological complete response in non-small cell lung cancer: a systematic review and meta-analysis

Qian Feng  1 , Xiaoxia Yan  2 , Liping Gao  2 , Hui Li  2 , Baik Sarah  3 , Russo Anna  4 , Hongying Jiang  1
Affiliations

The effect of tislelizumab on complete and pathological complete response in non-small cell lung cancer: a systematic review and meta-analysis

Qian Feng et al. Front Oncol. .

Abstract

Background: Immune checkpoint inhibitors have transformed non-small cell lung cancer (NSCLC) treatment, and while overall survival (OS) and progression-free survival (PFS) are well-established, a comprehensive meta-analysis focusing on complete response (CR) and pathological complete response (pCR) with tislelizumab-based therapies in NSCLC is lacking.

Methods: This systematic review and meta-analysis was conducted following PRISMA guidelines. A thorough literature search was performed across PubMed, Embase, and Web of Science. We included both randomized controlled trials and observational studies of tislelizumab in NSCLC, focusing on extracting data for radiological complete response (CR, based on RECIST 1.1 criteria) and pathological complete response (pCR, defined as absence of residual invasive cancer in resected surgical specimens). Risk of bias was assessed using the Cochrane Collaboration's tool and the Newcastle-Ottawa Scale. Statistical analyses were performed using the 'meta' package in R. 95% confidence intervals (CIs) and odds ratios (ORs) were calculated for CR and pCR, and subgroup analyses were conducted.

Results: 7 studies were enrolled in the meta-analysis. The results on pCR showed significant heterogeneity (I2 = 92.5%), with a random effects OR of 2.1103 (95% CI: 0.5195 to 8.5727). Subgroup analysis for pCR by disease type revealed a statistically significant difference between NSCLC and SCC only subgroups under the common effect model (p < 0.001). Furthermore, the pCR subgroup analysis by comparator drug showed a statistically significant difference (p < 0.0001) between Pembrolizumab+Chemotherapy (OR 0.6968, 95% CI: 0.3803 to 1.2767) and Chemotherapy alone (OR 7.3123, 95% CI: 2.9204 to 18.3092). For CR, the meta-analysis demonstrated minimal heterogeneity (I2 = 0.0%), yielding a significant random effects OR of 2.6277 (95% CI: 1.2858 to 5.3699). Subgroup analysis for CR comparing tislelizumab plus chemotherapy to chemotherapy alone showed a significant advantage (OR 3.8690, 95% CI: 1.5423 to 9.7059).

Conclusion: Tislelizumab combined with chemotherapy significantly improves CR rates in NSCLC compared to chemotherapy alone. While pCR data exhibit high heterogeneity, the findings highlight tislelizumab's role in achieving deep tumor responses.

Keywords: NSCLC; complete response; meta-analysis; pathological complete response; tislelizumab.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram shows the selection process of studies.
Figure 2
Figure 2
Bias analysis of meta-analysis on tislelizumab in NSCLC.
Figure 3
Figure 3
Forest plot of pCR meta-analysis of tislelizumab plus chemotherapy for NSCLC.
Figure 4
Figure 4
Funnel plot of pCR meta-analysis of tislelizumab plus chemotherapy for NSCLC.
Figure 5
Figure 5
Forest plot of pCR subgroup analysis by disease type for tislelizumab plus chemotherapy in NSCLC.
Figure 6
Figure 6
Forest plot of pCR subgroup analysis by comparator drug used in the control arm for tislelizumab plus chemotherapy in NSCLC.
Figure 7
Figure 7
Forest plot of complete response meta-analysis of tislelizumab combined with chemotherapy for NSCLC.
Figure 8
Figure 8
Funnel plot of complete response meta-analysis of tislelizumab combined with chemotherapy for NSCLC.
Figure 9
Figure 9
Forest plot of complete response subgroup meta-analysis of tislelizumab combined with chemotherapy for NSCLC focusing on studies where the control arm involved another immunotherapy combined with chemotherapy.
Figure 10
Figure 10
Forest plot of complete response subgroup meta-analysis of tislelizumab combined with chemotherapy for NSCLC focusing on studies where the control arm involved chemotherapy only.
See this image and copyright information in PMC

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