Daiichi Sankyo has announced the dosing of first patient in the DESTINY-Ovarian01 Phase III trial’s randomisation phase, assessing Enhertu (trastuzumab deruxtecan) with bevacizumab versus bevacizumab alone as first-line maintenance therapy for ovarian cancer.
The trial focuses on patients with human epidermal growth factor receptor 2 (HER2) expressing (immunohistochemistry [IHC] 3+/2+/1+) advanced high-grade epithelial ovarian cancer, following initial treatment with platinum-based chemotherapy plus bevacizumab.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
This randomised, multi-centre, global, open-label, Phase III trial is assessing the safety and efficacy of the Enhertu (5.4mg/kg) combination in the indicated population.
Prior to randomisation, a non-randomised safety run-in phase assessed the safety profile of the combination.
The trial’s primary endpoint is progression-free survival (PFS) as determined by blinded independent central review in the HER2 IHC 3+/2+ population.
Overall survival (OS) in the same population is the key secondary endpoint.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataOther secondary endpoints include PFS and OS in the broader HER2 IHC 3+/2+/1+ population, as well as investigator-assessed PFS in both HER2 subgroups.
Nearly 580 participants will be enrolled at sites across Europe, Asia, South America, and North America.
The study is being conducted in partnership with the European Network of Gynecological Oncological Trial Groups (ENGOT), with Spanish group GEICO as the lead ENGOT organisation, The GOG Foundation, and Asia-Pacific Gynecologic Oncology Trials Group (APGOT).
Enhertu is a HER2 directed exatecan derivative (DXd) antibody drug conjugate, jointly commercialised and developed with AstraZeneca and discovered by Daiichi Sankyo.
Daiichi Sankyo late-stage oncology clinical development head Abderrahmane Laadem said: “Results from the ovarian cancer cohort of DESTINY-PanTumor02 demonstrated clinically meaningful and durable responses in previously treated patients with HER2 expressing advanced ovarian cancer, supporting the development of Enhertu in earlier lines of therapy.”
In March 2025, Enhertu showed clinically meaningful improvement in the DESTINY-Gastric04 Phase III trial, regarding the primary endpoint of OS in individuals with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
