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Zie ook dit artikel: https://kanker-actueel.nl/NL/sacituzumab-govitecan-trodelvy-een-anti-lichaam-medicijn-geeft-zeer-goede-resultaten-bij-borstkankerpatienten-met-voorbehandelde-uitgezaaide-triple-negatieve-borstkanker-met-trop-2-mutatie-in-vergelijking-met-chemotherapie.html

13 november 2025: Bron: Nature medicine 2025 Jun; 31(6):1969-1975

Uit de resultaten van de OptiTROP-Breast01 fase 3 studie blijkt dat Sacituzumab Tirumotecan (merknaam Trodelvy) uitstekende resultaten laat zien bij patiënten met voorbehandelde gevorderde triple negatieve borstkanker in vergelijking met chemotherapie. 
De deelnemende patiënten werden willekeurig ingedeeld in twee groepen, 130 patiënten ontvingen Sacituzumab Tirumotecan en 133 patiënten kregen chemotherapie.

Uit het abstract van de OptiTROP-Breast01 fase 3 studie vertaalde resultaten:
  • Het primaire eindpunt van ziekteprogressievrije overleving (PFS) door middel van geblindeerde onafhankelijke centrale review (BICR) werd behaald op basis van de in het protocol gespecificeerde interim-analyse.
  • Bij de uiteindelijke analyse was de mediane PFS volgens BICR 6,7 maanden met Sacituzumab Tirumotecan (95% betrouwbaarheidsinterval (BI), 5,5–8,0) en 2,5 maanden met chemotherapie (95% BI, 1,7–2,7) (gevarenratio (HR), 0,32; 95% BI, 0,24–0,44; P < 0,00001).
  • Tegelijkertijd werd bij de in het protocol gespecificeerde tussentijdse analyse voor algehele overleving (OS) de mediane OS niet bereikt (95% BI, 11,2 maanden tot niet schatbaar (NE)) met Sacituzumab Tirumotecan versus 9,4 maanden  met chemotherapie (95% BI, 8,5–11,7) (HR, 0,53; 95% BI, 0,36–0,78; P = 0,0005).
  • Het percentage patiënten met een objectieve respons was 45,4% met Sacituzumab Tirumotecan en 12,0% met chemotherapie.
  • De mediane responsduur was 7,1 maanden​ met Sacituzumab Tirumotecan (95% BI, 5,6-NE) en 3,0 maanden met chemotherapie (95% BI, 2,5-NE) .
  • De meest voorkomende behandelingsgerelateerde bijwerking van Sacituzumab Tirumotecan was hematologische toxiciteit.

Conclusie: 
Sacituzumab Tirumotecan toonde statistisch significante en klinisch relevante verbeteringen in PFS in vergelijking met chemotherapie, met een beheersbaar veiligheidsprofiel. De onderzoeksresultaten ondersteunen Sacituzumab Tirumotecan als een aanvullende effectieve behandelingsoptie voor voorbehandelde uitgezaaide triple negatieve borstkanker.

Wereldwijd en ook in ziekenhuizen in Nederland en België loopt een vergelijkbare zogeheten open label fase III studie met totaal 1200 patiënten onder de naam: An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer.

Klik op deze link voor de studieomschrijving en welke ziekenhuizen in Nederland en België deelnemen. In bijna alle ziekenhuizen staat dat ze nog patiënten aannemen. 

Overigens wordt Sacituzumab Tirumotecan ook bij andere vormen van kanker met solide tumoren onderzocht waaronder met name bij longkanker. 

Het volledige studierapport van de OptiTROP-Breast01 fase 3 studie is tegen betaling in te zien. Hier het abstract van de studie:
  • Article
  • Published: 

Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial

Nature Medicine volume 31, pages1969–1975 (2025)Cite this article

Abstract

Chemotherapy remains a standard treatment option for metastatic triple-negative breast cancer (TNBC) but is associated with limited survival. Although some targeted antibody–drug conjugates have demonstrated clinical benefits and are considered standard therapy, persistent unmet medical needs remain due to varying accessibility. The OptiTROP-Breast01 phase 3 trial assessed sacituzumab tirumotecan (sac-TMT) versus chemotherapy in patients with locally recurrent or metastatic TNBC who had received two or more prior therapies, including at least one for metastatic disease. Patients were randomized to sac-TMT (n = 130) or chemotherapy (n = 133). The primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) was met based on the protocol-specified interim analysis. At final analysis, the median PFS by BICR was 6.7 (95% confidence interval (CI), 5.5–8.0) months with sac-TMT and 2.5 (95% CI, 1.7–2.7) months with chemotherapy (hazard ratio (HR), 0.32; 95% CI, 0.24–0.44; P < 0.00001). Concurrently, at the protocol-specified interim analysis for overall survival (OS), the median OS was not reached (95% CI, 11.2 months to not estimable (NE)) with sac-TMT and 9.4 (95% CI, 8.5–11.7) months with chemotherapy (HR, 0.53; 95% CI, 0.36–0.78; P = 0.0005). The percentage of patients with an objective response was 45.4% with sac-TMT and 12.0% with chemotherapy. The median duration of response was 7.1 (95% CI, 5.6–NE) months with sac-TMT and 3.0 (95% CI, 2.5–NE) months with chemotherapy. The most common treatment-related adverse event with sac-TMT was hematologic toxicity. Sac-TMT demonstrated statistically significant and clinically meaningful improvements in PFS compared to chemotherapy, with a manageable safety profile. The study findings support sac-TMT as an additional effective treatment option for pretreated metastatic TNBC. ClinicalTrials.gov identifier: NCT05347134.

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Conflict of interest statement

Competing interests: B.X. has served as advisor or consultant for Novartis and AstraZeneca. J.G., X.J., Y.D. and G.L. are employees of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. The other authors declare no competing interests.

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triple negatieve borstkanker, Sacituzumab tirumotecan, Trodelvy, overall overleving, Nature medicine, OptiTROP-Breast01 fase 3 studie, Trofuse-010 studie, ziekteprogressievrije overleving


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