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성균관대학교 의과대학, 삼성서울병원

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J. Thorac. Oncol., Oct 19 2025, S1556-0864(25)01015-9 | https://doi.org/10.1016/j.jtho.2025.08.011 Perioperative Pembrolizumab for Locally Advanced Thymic Epithelial Tumors: A Single-Arm, Phase 2 Trial

Yeong Hak Bang MD, PhD^a,b, Jae Myoung Noh MD, PhD ^c, Boram Lee MD, PhD ^d, Yoon-La Choi MD, PhD ^b,d,e,f, Kyungmi Yang MD, PhD ^c, Hongryull Pyo MD, PhD ^c, Hyunsu Kim PhD ^a, Jinyong Kim MD, PhD ^a, Hyun Ae Jung MD, PhD ^a, Jong-Mu Sun MD, PhD ^a, Se-Hoon Lee MD, PhD ^a,b,e, Jin Seok Ahn MD, PhD ^a, Myung-Ju Ahn MD, PhD ^a, Yeong Jeong Jeon MD, PhD^g, Junghee Lee MD, PhD ^g,Jong Ho Cho MD, PhD ^g, Hong Kwan Kim MD, PhD ^f,g, Yong Soo Choi MD, PhD^g, Seong Yong Park MD, PhD ^g, Sehhoon Park MD, PhD^a,e

^aDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
^bDepartment of Digital Health, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea
^cDepartment of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
^dDepartment of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
^eDepartment of Health Sciences and Technology, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea
^fDepartment of Clinical Research and Evaluation, Samsung Advanced Institute of Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea
^gDepartment of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

Drs. Bang and Noh contributed equally as first authors.
Drs. Seong Yong Park and Sehhoon Park are co-senior authors.
Address for correspondence: Sehhoon Park, MD, PhD

Abstract

Introduction: Complete surgical resection remains the only potentially curative option for thymic epithelial tumors (TETs). We hypothesized that adding perioperative pembrolizumab to standard therapy may improve response, resectability, and disease-free survival (DFS).

Methods: In this single-arm, prospective phase 2 trial, patients with potentially resectable TETs (Masaoka-Koga stages III-IV) received neoadjuvant docetaxel (75 mg/m2), cisplatin (75 mg/m2), and pembrolizumab (200 mg) every 3 weeks for 3 cycles, followed by surgery and maintenance pembrolizumab for 2 years. R1/R2-resected patients received adjuvant radiotherapy concomitant with pembrolizumab. The primary end point was a major pathologic response (MPR).

Results: From March 2020 to January 2025, 40 untreated patients were recruited, including those with WHO B3 thymoma (n = 7, 17.5%) or thymic carcinoma (n = 29, 72.5%). Most were diagnosed with stage IV disease (n = 31, 77.5%). The median follow-up duration was 27.5 months (95% confidence interval [CI]: 22.0-39.2), and 28 patients (70.0%) underwent surgical resection. Among the patients who received surgery, MPR and pathologic complete response were observed in 13 (46.4%) and five (17.9%) patients, respectively. Notably, all cases of MPR and pathologic complete response occurred exclusively in patients with thymic carcinoma, not in those with thymoma. The 1-year DFS rate was 91.0% (95% CI: 79.9-100.0), and the median DFS was 49.3 months (95% CI: 25.3-not reached) from the time point of surgery. Most of the adverse events were grade 1 or 2 (n = 21, 52.5%), with nine (22.5%) grade 3 and five (12.5%) grade 4. Two patients with thymoma died from myocarditis.

Conclusions: Perioperative pembrolizumab demonstrated promising rates of MPR, R0 resection, and long-term DFS in stage III to IV TETs.

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