Comparison of efficacy and surgery-related safety of perioperative tislelizumab and pembrolizumab with neoadjuvant chemotherapy for resectable non-small cell lung cancer: a retrospective cohort study

Introduction

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases (1). Approximately one-third of patients with NSCLC are diagnosed at locally advanced stages (2,3). Despite undergoing radical surgery, 30–55% of these patients develop disease recurrence and consequently cancer death (4,5). Recently, neoadjuvant or perioperative immunotherapies are in the spot light in NSCLC treatment, with the evidence of reducing tumor size and improvement of complete resection rate (6). The CheckMate-816 trial was a milestone in the development of combination comprising neoadjuvant chemotherapy with nivolumab, demonstrating the efficacy and safety of this approach. The trial reported a median event-free survival (EFS) of 31.6 months [95% confidence interval (CI): 30.2–not reached] in the group receiving nivolumab combined with chemotherapy, compared with 20.8 months (95% CI: 14.0–26.7) in the group treated with chemotherapy alone. Additionally, the rates of pathologic complete response (pCR) were 24.0% (95% CI: 18.0–31.0%) and 2.2% (95% CI: 0.6–5.6%), respectively [odds ratio (OR) =13.94; 99% CI: 3.49–55.75; P<0.001], highlighting the excellent efficacy of neoadjuvant immunochemotherapy (7,8).

Tislelizumab was approved by the Chinese National Medical Products Administration for the first-line treatment of advanced NSCLC. In the RATIONALE-315 trial, which examined the efficacy of perioperative tislelizumab with neoadjuvant chemotherapy showed the favorable results that perioperative tislelizumab significantly improved EFS as compared with placebo [hazard ratio (HR) =0.56, 95% CI: 0.40–0.79; P<0.001]. The major pathologic response (MPR) rate was significantly higher in the tislelizumab group (56%, 95% CI: 50–63%) than in the placebo group (15%, 95% CI: 11–20%; P<0.001). The pCR rate was significantly higher in the tislelizumab group (40.7%, 95% CI: 27.9–42.1%) than in the placebo group (5.7%, 95% CI: 6.2–21.5%; P<0.001). Among the 226 patients in the tislelizumab group, 31 (14%) died from any causes during the study period, and 45 of 227 patients (20%) in the placebo group died during the study period, with an overall manageable safety profile (9).

Pembrolizumab is an immunotherapeutic agent approved by the U.S. Food and Drug Administration for the treatment of NSCLC (10). In the context of perioperative therapy, the second interim analysis of the KEYNOTE-671 phase III trial demonstrated that perioperative pembrolizumab combined with neoadjuvant chemotherapy, as compared with neoadjuvant chemotherapy alone, significantly improved the 36-month OS rate [71% (95% CI: 66–76%) vs. 64% (95% CI: 58–69%); HR =0.72, 95% CI: 0.56–0.93%; P=0.005] and median EFS [42.7 months (95% CI: 32.9–not reached) vs. 18.3 months (95% CI: 14.8–22.1)], demonstrating its satisfactory efficacy [HR =0.59 (95% CI: 0.48–0.72)] (11).

Simply comparing the data from 2 trials, perioperative tislelizumab therapy seems to provide better efficacy compared to perioperative pembrolizumab therapy in the treatment for resectable NSCLC. However, it is still uncertain which agent is preferable because patients’ background of both trials should be much different.

Some retrospective studies have compared the efficacy and surgery-related safety of tislelizumab and pembrolizumab in immunotherapy (12,13). However, there is still little evidence regarding the efficacy and surgery-related safety of perioperative tislelizumab comparing to pembrolizumab. The aim of this study was thus to evaluate the efficacy of perioperative tislelizumab + neoadjuvant chemotherapy with surgery compared to perioperative pembrolizumab + neoadjuvant chemotherapy in terms of pathological efficacy and postoperative survivals for potentially resectable stage IIA-IIIB NSCLC in real-world setting. We present this article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-1089/rc).

Methods

Patient cohort

This retrospective study examined patients with resectable stage IIA–IIIB NSCLC treated at Tangdu Hospital affiliated with Fourth Military Medical University from June 2018 to March 2024. In the screening of patients for enrollment in this study, patients with missing data were excluded. All patients underwent complete pre-treatment staging, which included computed tomography (CT) of the chest and abdomen and whole-body positron emission tomography-computed tomography (PET-CT) to define the disease stage according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system (14). For patients with radiologically enlarged or FDG-avid mediastinal or hilar lymph nodes (short-axis diameter ≥1 cm on CT or standardized uptake value suggestive of malignancy), pathological confirmation via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was mandated. Treatment with perioperative immunotherapy was initiated based on the confirmed histological diagnosis and resectable clinical stage, reflecting the standard of care at our institution during the study period. The eligible participants had undergone neoadjuvant therapy consisting of nab-paclitaxel for squamous cell carcinoma/pemetrexed for adenocarcinoma and platinum-based chemotherapy alongside with either tislelizumab or pembrolizumab, followed by surgical resection. Patients received tislelizumab 200 mg intravenously every 3 weeks or pembrolizumab 200 mg intravenously every 3 weeks, in combination with neoadjuvant chemotherapy (15,16). The planned neoadjuvant regimen consisted of 3–4 cycles, followed by surgical resection. The interval from the last dose of immunotherapy to surgery was typically 3–5 weeks. In the adjuvant phase, patients received the same immunotherapy agent for up to one year, as per institutional practice. The assignment to either the tislelizumab or pembrolizumab group was not randomized. The selection of the specific immuno-therapeutic agent was based on a combination of factors including drug availability during the study period, institutional guidelines, insurance coverage, and ultimately, the comprehensive assessment and preference of the treating physician in discussion with the patient. The patient data were extracted from an electronic medical records system, with clinical staging determined in accordance with the eighth edition of the AJCC staging manual. Surgical specimens were collected and analyses in all participants. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the institutional ethics board of Tangdu Hospital, Fourth Military Medical University (No. K-HG-202505-13) and individual consent for this retrospective analysis was waived.

Eligibility criteria

Patients were included if they met the following criteria: (I) age ≥18 years; (II) with pathologically confirmed resectable stages IIA–IIIB NSCLC (AJCC eighth edition); (III) with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (IV) with at least one measurable lesion before treatment as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines to assess treatment response; (V) who had completed planed cycle of neoadjuvant chemoimmunotherapy (with either tislelizumab or pembrolizumab) and surgical resection; (VI) with data regarding postoperative pathology results.

Exclusion criteria

Participants were ineligible for the study if any of the following criteria were met: (I) with previous therapeutic intervention targeting primary tumors or affected lymph nodes; (II) with contraindications to immune checkpoint inhibitor (ICI) therapy [active autoimmune diseases, organ transplant history, or uncontrolled systemic infections; severe interstitial lung disease (diffusing capacity of the lung for carbon monoxide <40%); specific genetic profiles] or platinum-based chemotherapy (severe bone marrow suppression (neutrophils <1.5×10⁹/L, platelets <50×10⁹/L); hepatic disfunction (aspartate aminotransferase, alanine aminotransferase >5 fold of upper limit of normal) or renal impairment (creatinine clearance <30 mL/min); uncontrolled infections or early pregnancy); (III) with uncontrolled severe comorbidities or systemic illnesses; (IV) who did not underwent surgical resection despite undergoing neoadjuvant immunochemotherapy; and (V) with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK), ROS1, RET, or other known driver alterations amenable to tyrosine kinase inhibitor (TKI) therapy.

Study design

The following demographic and treatment data were retrospectively extracted from the electronic medical records: age, sex, body mass index (BMI), smoking history, ECOG physical status, clinical stage, histology, clinical nodal stage (cN0–1 or cN2), surgical approach, extent of surgical resection, intraoperative blood loss (mL), postoperative chest tube duration (days), and postoperative hospital stays (days). The cut-off value of BMI (24 kg/m²) were based on the China-specific clinical criteria (17). Clinical stage and clinical nodal stage were based on the AJCC 8^th edition. Surgical approach included robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), thoracotomy, and conversion to thoracotomy. Extent of surgical resection included lobectomy, bilobectomy, sleeve resection/bronchoplasty, and pneumonectomy. Patient follow-up was conducted through regular outpatient visits and telephone interviews to assess survival status, disease recurrence, and metastasis.

Observation of indexes

All patients underwent systematic mediastinal lymph node dissection according to institutional standards. The dissection routinely included stations 2R, 4R, 7, 8, and 9 for right-sided tumors, and stations 4L, 5, 6, 7, 8, and 9 for left-sided tumors. The pCR was considered to be the total eradication of tumor cells in both the primary lung cancer site and associated lymph nodes following neoadjuvant treatment and subsequent surgical resection. MPR was defined as 10% or fewer viable tumor cells remaining in the primary tumor, irrespective of lymph node involvement. Notably, cases in which the primary site was considered to reach pCR but lymph nodes contained residual tumor cells were considered to be MPR. Pathological response evaluation was performed following International Association for the Study of Lung Cancer (IASLC) recommendations (18). Surgical specimens were processed with complete embedding of the tumor bed and representative sections of all residual tumors. Hematoxylin and eosin staining was used for all specimens. All pathological assessments were reviewed by two experienced thoracic pathologists, with consensus review in cases of disagreement. Pathologists were blinded to the specific immunotherapy agent received when evaluating pathological response. Treatment efficacy after neoadjuvant therapy was assessed according to RECIST version 1.1, at baseline and after completion of neoadjuvant therapy prior to surgery. Assessments were conducted by institutional radiologists as part of routine clinical care, with a single reader for each case. Radiologists were not blinded to the treatment regimen. In cases of uncertain response, consensus was reached through discussion with the multidisciplinary tumor board. The following classifications: complete response (CR), the disappearance of all target lesions with no emergence of new lesions; partial response (PR), a reduction of 30% or more in the total diameter of target lesions; stable disease (SD), neither sufficient shrinkage to meet PR criteria nor significant growth to qualify as progressive disease; and progressive disease (PD), either a 20% or greater increase in the total diameter of target lesions or the appearance of new lesions. Disease progression was defined as meeting the criteria for PD. The ORR was calculated as the sum of CR and PR cases divided by the total number of cases multiplied by 100. OS was measured from the beginning of neoadjuvant treatment until death from any cause. EFS was defined as the duration from treatment initiation to the first instance of disease progression—whether local or distant—or death from any cause. Censoring occurred at the last known follow-up for patients without events.

Statistical analyses

The primary endpoint was the pCR rate. Secondary endpoints included the ORR, MPR rate, OS, EFS, and surgery-related safety. To assess the differences in nominal categorical variables, either the Fisher exact test or the chi-squared test was employed. For ordinal categorical data, the Wilcoxon rank-sum test was applied. Continuous variables that conform to a normal distribution use the t-test and those that do not use the Mann-Whitney U-test. The strength of associations between clinical characteristics and treatment response was quantified by calculating odds ratios (OR) with 95% CI using univariate logistic regression. The median follow-up duration was calculated via the reverse Kaplan-Meier approach. To mitigate confounding variables, PSM was implemented. Propensity scores for the tislelizumab and pembrolizumab cohorts were derived using a logistic regression model, with covariates related to the selection of introducing tislelizumab or pembrolizumab such as age, sex, BMI, smoking history, clinical stage, histology, clinical nodal stage (cN0–1 vs. cN2), being incorporated. When assessing surgery-related safety, surgical approach and extent of surgical resection were additionally included in the PSM covariate model to balance intergroup heterogeneity. Using a nearest-neighbor algorithm with a caliper width of 0.20 logits of the standard deviation, we matched the tislelizumab-treated patients with their pembrolizumab counterparts at a ratio of 1:1. The success of PSM was verified by standardized mean differences (SMDs), with an SMD ≤0.10 indicating adequate balance in baseline characteristics between the matched groups. Survival analysis was performed via Kaplan-Meier methods, and comparisons were made with log-rank tests. The statistical tests were two-tailed, with P value <0.05 as statistical significance. All statistical analyses were performed with SPSS version 26.0 (IBM Corp., Armonk, NY, USA) and R software version 4.3.2 (The R Foundation for Statistical Computing), including the “survminer” and “MatchIt” R packages.

Results

Baseline demographic and clinical characteristics

We collected the data from 736 patients with NSCLC receiving perioperative immunotherapy. After screening, 245 patients consisted of 75 in the tislelizumab group and 170 in the pembrolizumab group were included in the analysis (Figure 1).

Figure 1 Patient selection flowchart. ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer.

The majority of patients were over 60 years old, were male, had a history of smoking, and were with squamous cell carcinoma. Before matching, the two groups showed a significant difference in clinical nodal stage (with cN2; P=0.012), while no significant differences were observed for sex, age, BMI, smoking history, clinical stage, histology (Table 1). After 1:1 covariate matching, each group included 72 patients, resulting in a well-balanced comparison between the two treatment groups with SMD ≤0.10 (Figure 2).

Figure 2 Evaluation of the PSM efficacy. (A) Probability density analysis before and after PSM. (B) SMD of variables before and after PSM. BMI, body mass index; PSM, propensity score matching; SMD, standardized mean difference.

Efficacy

Regarding the treatment efficacy of the two drugs, the observational endpoints selected were pCR as primary endpoint and ORR, MPR as secondary endpoint. Before matching, among the 245 patients, 113 patients achieved pCR, with no significant difference observed in the percentage with a pCR between the tislelizumab and pembrolizumab groups [42.7% (n=32) vs. 47.7% (n=81); P=0.47]. The 56 patients achieved objective response, with no significant difference in the ORR between the groups [58.7% (n=44) vs. 65.9% (n=112); P=0.28] on computed tomography after neoadjuvant therapy. In addition, a total of 166 patients achieved MPR, and no significant difference in the percentage with a MPR was found between the groups [66.7% (n=50) vs. 68.2% (n=116); P=0.81] (Table 2).

Among 72 matched, 60 patients achieved pCR, with no significant difference in the pCR rate between the tislelizumab and pembrolizumab groups [43.1% (n=31) vs. 40.3% (n=29); P=0.74]. For secondary endpoint, 90 patients achieved objective response, with no significant difference in ORR difference between the groups [58.3% (n=42) vs. 66.7% (n=48); P=0.30]. Moreover, a total of 96 patients achieved MPR, with no significant in the MPR rate between the groups [66.7% (n=48) vs. 66.7% (n=48); P>0.99] (Table 2).

In further subgroup analysis before and after PSM matching, there were no statistically significant differences in pCR, and MPR between tislelizumab and pembrolizumab in any subgroup (P>0.05) (Figures 3,4). Additionally, in a specific subgroup analysis of ORR after PSM, it was found that tislelizumab was more effective than pembrolizumab in lung adenocarcinoma (OR =0.024, 95% CI: 0.001–0.468, P=0.01); however, the small sample size of the subgroup (8 patients in tislelizumab group and 7 patients in pembrolizumab) limited the significance of this result (Figure 5).

Figure 3 Subgroup analysis of pCR before and after PSM. (A) Forest plot of pCR before PSM. (B) Forest plot of pCR after PSM. BMI, body mass index; CI, confidence interval; OR, odds ratio; pCR, pathologic complete response; PSM, propensity score matching.

Figure 4 Subgroup analysis of MPR before and after PSM. (A) Forest plot of MPR before PSM. (B) Forest plot of MPR after PSM. BMI, body mass index; CI, confidence interval; OR, odds ratio; MPR, major pathologic response; PSM, propensity score matching.

Figure 5 Subgroup analysis of ORR before and after PSM. (A) Forest plot of ORR before PSM. (B) Forest plot of ORR after PSM. BMI, body mass index; CI, confidence interval; OR, odds ratio; ORR, objective response rate; PSM, propensity score matching.

Survival

The median follow-up time was 34.4 months [interquartile range (IQR), 24.2–42.7 months] in the tislelizumab group and 35.9 months (IQR, 25.3–48.2 months) in the pembrolizumab group. The 3-year OS and EFS rates for the entire cohort were 80.5% (95% CI: 74.5–87.0%) and 69.0% (95% CI: 62.1–76.6%), respectively.

Prior to PSM, the 3-year OS rate in the tislelizumab group was 80.6% (95% CI: 67.7–96.1%), while the 3-year EFS rate was 79.1% (95% CI: 67.0–93.3%). In the pembrolizumab group, the 3-year OS rate was 79.7% (95% CI: 72.8–87.1%), while the 3-year EFS rate was 65% (95% CI: 57.0–74.1%). There were no significant differences observed in OS or EFS between the tislelizumab and pembrolizumab groups before PSM (OS: HR =1.53, 95% CI: 0.70–3.35, P=0.28; EFS: HR =1.74, 95% CI: 0.92–3.27, P=0.08) (Figure 6A,6B).

Figure 6 Kaplan-Meier curves for OS and EFS. (A) OS before PSM. (B) EFS before PSM. (C) OS after PSM. (D) EFS after PSM. CI, confidence interval; EFS, event-free survival; HR, hazard ratio; OS, overall survival; PSM, propensity score matching.

After PSM, 3-year OS rates in the tislelizumab group and pembrolizumab group were 79.2% (95% CI: 65.2–96.1%) and 75.4% (95% CI: 63.6–89.2%). The 3-year EFS rates in the tislelizumab group and pembrolizumab group were 77.7% (95% CI: 64.8–93.2%) and 58.5% (95% CI: 46.1–74.2%). The OS and EFS remained non-significantly different between the two groups (OS: HR =1.45, 95% CI: 0.60–3.51, P=0.41; EFS: HR =1.93, 95% CI: 0.96–3.86, P=0.057) (Figure 6C,6D).

Surgery-related safety

Surgical approach and extent of surgical resection were additionally included in the PSM covariate model to balance intergroup heterogeneity. After 1:1 covariate matching, each group included 64 patients, and the two treatment groups were well balanced with SMD ≤0.10 (Table S1, Figure S1). After additional PSM, no significant differences were found between the two groups in terms of operative time, intraoperative blood loss, postoperative chest tube duration, or postoperative hospital days (P>0.05). These findings indicate that tislelizumab and pembrolizumab showed equivalent risk of bleeding and have comparable safety profiles in terms of surgical outcomes (Table 3).

Discussion

In this single-institutional retrospective study, we compared the drug efficacy and surgery-related safety of tislelizumab and pembrolizumab in combination with neoadjuvant chemotherapy for patients with resectable NSCLC. By matching potential influencing factors, we evaluated pCR as primary endpoint, MPR, ORR, OS, and EFS as secondary endpoint, as well as operative time, intraoperative blood loss, postoperative chest tube duration, and postoperative hospital stays in both groups. Our findings showed that both drugs demonstrated comparable efficacy and surgery-related safety in the context of neoadjuvant chemotherapy combined with perioperative immunotherapy for resectable NSCLC.

In the RATIONALE-315 study, the tislelizumab group demonstrated a pCR rate of 40.7% and an MPR rate of 56.2% (9). In contrast, in the KEYNOTE-671 phase III trial, the pembrolizumab group had a pCR rate of 18.1% and an MPR rate of 30.2% (19). However, the RATIONALE-315 study examined patients with stage II–IIIA NSCLC, while the KEYNOTE-671 trial included patients with stage II–IIIB NSCLC. Given that a head-to-head randomized controlled trial (RCT) between these agents may not be feasible, we utilized PSM in this observational study to reduce baseline confounding and facilitate a more balanced comparison of efficacy. In our study, after PSM, the pCR rate (43.1% in the tislelizumab group and 40.1% in the pembrolizumab group) and MPR rate (66.7% in tislelizumab group and 66.7% in pembrolizumab group) were different from those in the KEYNOTE-671 trial but close to those in the RATIONALE-315 trial. The difference in the chemotherapy drugs used in combination may be a potential influencing factor for comparing the effects across different trials. The KEYNOTE-671 trial examined a chemotherapy regimen of platinum and pemetrexed/gemcitabine, whereas our study and the RATIONALE-315 trial examined patients with squamous cell carcinoma received albumin-bound paclitaxel and platinum-based combination chemotherapy, while patients with adenocarcinoma received pemetrexed and platinum-based combination chemotherapy. Moreover, in our study the selected population consisted of patients who underwent surgery after neoadjuvant chemotherapy combined with perioperative immunotherapy, which might have excluded patients whose disease progressed during neoadjuvant therapy and could not undergo surgery.

Critically, our analysis found no significant differences in surgery-related safety between tislelizumab and pembrolizumab. This demonstrates that the choice between these two agents does not compromise surgical feasibility or short-term postoperative outcomes. Given this equivalent safety profile, other factors such as drug availability and cost may guide clinical decision-making. Our results, suggesting tislelizumab’s potential cost-effectiveness, could therefore inform treatment strategies in the Chinese healthcare context. This inference is based on the demonstrated comparable efficacy and safety profile in this study, coupled with well-established pharmacoeconomic evidence showing a significantly lower drug acquisition cost for tislelizumab (20,21).

This study has several strengths, most notably the application of propensity score matching (PSM) to minimize selection bias and enhance the comparability between treatment groups. However, several limitations warrant acknowledgment. The non-randomized, retrospective design from a single institution constitutes the primary limitation, as the choice between tislelizumab and pembrolizumab was influenced by clinical factors such as drug availability and insurance coverage, potentially introducing selection bias. Although PSM was employed to balance key baseline characteristics and reduce confounding, the possibility of residual unmeasured confounding cannot be excluded. Additionally, the lack of PD-L1 testing data prevents assessment of its potential influence on outcomes. Furthermore, the absence of systematically collected data on treatment-related adverse events and complications precludes a comprehensive safety evaluation. Moreover, the inclusion only of patients undergoing lobectomy or more extensive resections limits the generalizability of our findings to those receiving parenchyma-sparing procedures. The relatively small sample size may also constrain the broader applicability of the results. Future large-scale, prospective randomized trials are needed to definitively establish the comparative efficacy and safety of these two regimens in the perioperative management of resectable NSCLC.

Conclusions

Our findings suggest that the efficacy of tislelizumab and pembrolizumab in patients with potentially resectable stage IIA–IIIB NSCLC receiving perioperative therapy is comparable, as is their surgery-related safety.

Acknowledgments

We would like to thank the Department of Thoracic Surgery at Tangdu Hospital for support in this study.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-1089/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-1089/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-1089/prf

Funding: This study was supported by Shaanxi Provincial Department of Science and Technology (No. 2023-CX-TD-64) and the National Natural Science Foundation of China (No. 82173252 to X.Y.).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-1089/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the institutional ethics board of Tangdu Hospital, Fourth Military Medical University (No. K-HG-202505-13) and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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