Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Oct 19:S1556-0864(25)01015-9.
doi: 10.1016/j.jtho.2025.08.011. Online ahead of print.

Perioperative Pembrolizumab for Locally Advanced Thymic Epithelial Tumors: A Single-Arm, Phase 2 Trial

Yeong Hak Bang  1 , Jae Myoung Noh  2 , Boram Lee  3 , Yoon-La Choi  4 , Kyungmi Yang  2 , Hongryull Pyo  2 , Hyunsu Kim  5 , Jinyong Kim  5 , Hyun Ae Jung  5 , Jong-Mu Sun  5 , Se-Hoon Lee  6 , Jin Seok Ahn  5 , Myung-Ju Ahn  5 , Yeong Jeong Jeon  7 , Junghee Lee  7 , Jong Ho Cho  7 , Hong Kwan Kim  8 , Yong Soo Choi  7 , Seong Yong Park  7 , Sehhoon Park  9
Affiliations
Free article

Perioperative Pembrolizumab for Locally Advanced Thymic Epithelial Tumors: A Single-Arm, Phase 2 Trial

Yeong Hak Bang et al. J Thorac Oncol. .
Free article

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.

Clinical trial registration: NCT03858582 (MK3475-971).

Keywords: Immunotherapy; Locally advanced; Perioperative treatment; Thymic epithelial tumor.

PubMed Disclaimer

Conflict of interest statement

Disclosure Dr. Jung reports having advisory roles at Yuhan, Guardant, and AIMEDBIO and received research funding from Yuhan. Dr. Jin Seok Ahn received honoraria from Pfizer, Roche, BC World Pharmaceutical, Yuhan, Hanmi, Novartis, JW Pharmaceutical, Amgen, Boehringer Ingelheim, Menarini, Kyowa Kirin, AstraZeneca, Bayer, Lilly, Takeda, Boryung, and Samyang and has advisory roles at Bayer, Yooyoung Pharmaceutical Co., Ltd., Pharmbio Korea, Guardant Health, Yuhan, ImmuneOncia, Therapex, Daiichi Sankyo Korea, and Roche. Dr. Myung-Ju Ahn received honoraria from AstraZeneca, Lilly, Merck Sharp & Dohme, Takeda, Amgen, Merck Serono, and Yuhan; reports advisory roles at AstraZeneca, Lilly, Merck Sharp & Dohme, Takeda, Alpha Pharmaceutical, Amgen, Merck Serono, Pfizer, Yuhan, and Arcus Ventures; and received research funding from Yuhan. Dr. Se-Hoon Lee received honoraria from AstraZeneca/MedImmune, Roche, Merck, Lilly, and Amgen; has advisory roles at AstraZeneca, Roche, Merck, Pfizer, Lilly, Bristol Myers Squibb/Ono, Takeda, Janssen, and IMBdx; and received research funding from Merck, AstraZeneca, and Lunit. The remaining authors declare no conflict of interest.

Associated data

LinkOut - more resources