
Enhertu goes adjuvant in endometrial

Not long after starting a pivotal trial of Enhertu in first-line endometrial cancer, AstraZeneca and Daiichi have revealed plans for a new study in adjuvant disease. According to a recent listing on clinicaltrials.gov, the Destiny-Endometrial02 study will enrol post-surgery patients with HER2 expression who haven’t received previous therapy, including neoadjuvant therapy. They will be randomised to either adjuvant Enhertu or chemo, with radiotherapy optional in both arms; the primary endpoint will be disease-free survival. In March, Astra began the Destiny-Endometrial01 trial in first-line disease; intriguingly, this includes an arm testing Enhertu plus rilvegostomig, Astra’s anti-TIGIT x PD-1 MAb, despite TIGIT’s poor track record. Daiichi also recently started a phase 3 study of Enhertu as first-line maintenance therapy in ovarian cancer. Destiny-Endometrial02 is the eighteenth Enhertu pivotal study, according to OncologyPipeline, with nine of these outside the drug’s main breast cancer use. The next trials to read out should be Destiny-Breast05, in adjuvant breast cancer, and Destiny-Lung04, in first-line NSCLC with HER2 exon 19 or 20 mutations, with data from both expected in the second half.
Enhertu trials in endometrial cancer
Trial | Sponsor | Setting | Regimen | Primary endpoint | Primary completion |
---|---|---|---|---|---|
Destiny-Endometrial01 | AstraZeneca | 1st-line HER2-expressing (IHC 2+/3+) pMMR endometrial cancer | Enhertu + rilvegostomig or Keytruda, vs Keytruda + chemo | PFS | Started Mar 2025; primary completion Jan 2029 |
Destiny-Endometrial02 | Daiichi Sankyo | Adjuvant HER2-expressing (IHC 2+/3+) endometrial cancer | Enhertu +/- radiotherapy, vs chemo +/- radiotherapy | DFS | To start Aug 2025; primary completion Mar 2032 |
Source: OncologyPipeline & clinicaltrials.gov.
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