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24 juli 2026: Zie ook in gerelateerde artikelen hiernaast of hieronder.

24 juli 2026: Sacituzumab tirumotecan = sac-TMT is en wordt ook onderzocht bij andere vormen van kanker waaronder triple negatieve borstkanker en mesothelioma en galwegenkanker

24 juli 2026: Bron: persbericht Kelun-Biotech, the Lancet

Sacituzumab tirumotecan = sac-TMT een zogeheten topoisomerase I-remmer in combinatie met pembrolizumab = Keytruda verbeterde de ziekteprogressievrije overleving beduidend langer ten opzichte van chemotherapie plus pembrolizumab = Keytruda als eerstelijnsbehandeling voor patiënten met PD-L1-positieve lokaal gevorderde of uitgezaaide niet-kleincellige longkanker

Sacituzumab tirumotecan = sac-TMT is een TROP2-gerichte ADC, samengesteld uit een gehumaniseerd anti-TROP2 monoklonaal antilichaam dat via een bifunctionele linker is gekoppeld aan een belotecan-derivaat, een zogeheten topoisomerase I-remmer dus.

"De positieve resultaten van zowel de OptiTROP-Lung05 studie als de OptiTROP-Lung06 studie bevestigen het sterke synergetische effect van Sacituzumab tirumotecan = sac-TMT in combinatie met pembrolizumab = Keytruda. Dit ondersteunt het potentieel van deze combinatietherapie voor een brede eerstelijnsbehandeling van niet-kleincellige longkanker = NSCLC en biedt nieuwe behandelingsmogelijkheden voor patiënten met verschillende PD-L1-expressieniveaus", aldus Michael Ge, CEO van Kelun-Biotech.

Hiermee werd het primaire eindpunt van de fase 3 OptiTROP-Lung06 studie bereikt tijdens een vooraf vastgestelde tussentijdse analyse, aldus een persbericht van Kelun-Biotech.

De resultaten uit de OptiTROP-Lung05 studie is gepubliceerd in the Lancet. Het volledige studierapport is tegen bepaalde voorwaarden gratis in te zien of te downloaden,:

ArticlesVolume 407, Issue 10548p2607-2619June 27, 2026

Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial

Affiliations & Notes
aDepartment of Oncology, Shanghai East Hospital, Tongji University, Shanghai, China
bDepartment of Medical Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China
cDepartment of Oncology, Shengjing Hospital, China Medical University, Shenyang, China
dDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China
eDepartment of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
fDepartment of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai, China
gNational Engineering Research Center of Targeted Biologics, Chengdu, China
hThoracic Radiation Oncology Department 1, Hunan Cancer Hospital, Changsha, China
iThoracic Medical Oncology Department 2, Hunan Cancer Hospital, Changsha, China
jDepartment of Internal Medicine–Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China
kDepartment of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
lDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China
mThoracic Medical Oncology Department 3, Hunan Cancer Hospital, Changsha, China
nDepartment of Respiratory, Shanxi Province Cancer Hospital, Taiyuan, China
oDepartment of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Institute of Cancer Research, Henan Academy of Innovations in Medical Science, Zhengzhou, China
pDepartment of Oncology, Mianyang Central Hospital, Mianyang, China
qDepartment of Thoracic Medical Oncology, Fujian Cancer Hospital, Fuzhou, China
rDepartment of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
sDepartment of Thoracic Oncology Radiotherapy, Jiangxi Cancer Hospital, Nanchang, China
tDepartment of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China
uMedical Oncology of Respiratory Medicine, Guangxi Medical University Cancer Hospital, Nanning, China
vDepartment of Oncology, Cancer Prevention and Treatment Institute of Chengdu, Department of Oncology, Chengdu Fifth People's Hospital, (The Second Clinical Medical College, Affiliated Fifth People's Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China
wDepartment of Oncology, Dongguan People's Hospital, Dongguan, China
xCancer Center, The First Hospital of Jilin University, Changchun, China
yDepartment of Pulmonary Medicine (Ward 2), Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China
zDepartment of Oncology, Xiangyang Central Hospital, Xiangyang, China
aaLung Cancer Center, West China Hospital of Sichuan University, Chengdu, China
abDepartment of Thoracic Oncology, Jiangxi Cancer Hospital, Nanchang, China
acDepartment of Thoracic Medicine I, Hunan Cancer Hospital, Changsha, China
adDepartment of Thoracic Surgery 3, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China
aeDepartment of Medical Oncology, Sir Run Run Shaw Hospital (SRRSH), Hangzhou, China
afClinical Research Center, Sichuan Kelun-Biotech Biopharmaceutical, Chengdu, China
*
Contributed equally
Co-senior authors
Article Info
Publication History:
Published May 29, 2026
Copyright: © 2026 Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
Linked Articles (1)
Cover Image - The Lancet, Volume 407, Issue 10548


Summary

Background

Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate, combined with programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitors, has shown promising antitumour activity as first-line therapy for non-small-cell lung cancer (NSCLC) in early-phase studies. Our aim was to evaluate the efficacy and safety of sac-TMT plus pembrolizumab as first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

Methods

In this randomised, open-label, phase 3 trial (OptiTROP-Lung05) conducted across 68 hospitals in China, eligible patients had locally advanced or metastatic NSCLC without targetable genomic alterations and a PD-L1 tumour proportion score (TPS) of 1% or greater. Patients were randomly assigned (1:1) to receive sac-TMT (4 mg/kg on days 1, 15, and 29) plus pembrolizumab (400 mg fixed dose on day 1), or pembrolizumab alone, administered intravenously every 6 weeks. The primary endpoint was progression-free survival, as assessed by blinded independent central review in the intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT06448312). Recruitment is complete, with the trial ongoing and the final analysis to be reported later.

Findings

Between June 7, 2024, and March 27, 2025, 741 patients were screened and 413 eligible patients were randomly assigned to receive sac-TMT plus pembrolizumab (n=208) or pembrolizumab alone (n=205). At the prespecified interim analysis, conducted after a median follow-up of 10·5 months (IQR 8·7–12·5), median progression-free survival was significantly longer with sac-TMT plus pembrolizumab than with pembrolizumab alone (not reached vs 5·7 months; stratified hazard ratio 0·35 [95% CI 0·26–0·47]; p<0·0001). The progression-free survival benefit was broadly consistent across subgroups, including patients with PD-L1 TPS of 1–49% (HR 0·28 [95% CI 0·19–0·41]) and those with PD-L1 TPS of 50% or greater (HR 0·47 [0·29–0·77]). Grade 3 or higher treatment-emergent adverse events occurred in 115 (55%) of 208 patients in the sac-TMT plus pembrolizumab group and 64 (31%) of 204 patients in the pembrolizumab group.

Interpretation

Among patients with PD-L1-positive advanced NSCLC without targetable genomic alterations, first-line treatment with sac-TMT plus pembrolizumab significantly prolonged progression-free survival compared with pembrolizumab alone. Therefore, sac-TMT plus pembrolizumab has the potential to redefine first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

Funding

Sichuan Kelun-Biotech Biopharmaceutical.

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