Daiichi Sankyo has announced the first subject dosing in the Phase III DESTINYEndometrial01 trial of Enhertu (trastuzumab deruxtecan) plus rilvegostomig or pembrolizumab versus platinum-based chemotherapy in conjunction with pembrolizumab as a first-line treatment for endometrial cancer.
The randomised, multi-centre, global, open-label trial is designed to evaluate this human epidermal growth factor receptor 2 (HER2)-directed antibody drug conjugate (ADC) in those with HER2-expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
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By GlobalDataIt will be carried out in partnership with The GOG Foundation and the European Network of Gynaecological Oncological Trials Group, aiming to assess the safety and efficacy of the ADC 5.4mg/kg.
Discovered by Daiichi, the ADC is being co-developed and commercialised with AstraZeneca.
With a randomisation ratio of 1:1:1, subjects will be given either Enhertu with rilvegostomig, Enhertu with pembrolizumab, or chemotherapy with pembrolizumab.
The study’s primary goal is to measure progression-free survival (PFS), evaluated by a blinded independent central review.
Overall survival rates serve as a key secondary endpoint. Additional measures include PFS as evaluated by investigators, duration of response and safety, and objective response rate.
Nearly 600 subjects across several sites in Europe, Asia, Oceania, North America, and South America will be enrolled in the trial.
Daiichi Sankyo therapeutic area oncology development head Mark Rutstein said: “Following the positive results in the endometrial cancer cohort of DESTINY-PanTumor02, which contributed to a tumour-agnostic approval for previously treated patients with HER2 positive metastatic tumours in several regions, we are initiating this first phase III trial of Enhertu in the first-line setting of advanced endometrial cancer.
“The DESTINY-Endometrial01 trial will help us better understand the role of Enhertu in combination with immunotherapy as a potential treatment strategy to help improve outcomes compared to the current standard of care in this specific gynaecological cancer setting.”
Last month, Enhertu, followed by paclitaxel, trastuzumab and pertuzumab (THP), showed pathologic complete response (pCR) rate improvement in the randomised DESTINY-Breast11 Phase III trial.
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