Enhertu goes pivotal in ovarian

AstraZeneca and Daiichi Sankyo already have an extensive pivotal programme for their HER2-targeting ADC Enhertu, and now ovarian cancer has been added to the mix, according to a recent listing on clinicaltrials.gov. Enhertu got a tumour-agnostic accelerated approval last year for late-line HER2-positive solid tumours, including ovarian cancer, based on the Destiny-Pantumor02 trial. But the latest study, dubbed Destiny-Ovarian01 and slated to begin in March, will evaluate Enhertu plus Avastin, versus Avastin alone, as first-line maintenance in HER2-expressing patients. Anti-angiogenic agents like Avastin have become standard of care for ovarian cancer maintenance; PARP inhibitors are also used, but are limited to BRCA-mutants – these patients are excluded from Destiny-Ovarian01. The primary endpoint of the study is progression-free survival in IHC3+ (HER2-positive) and IHC2+ (HER2-borderline) patients. Overall survival in this population is a secondary endpoint, as is PFS and OS in IHC3+/IHC2+/IHC1+ (including HER2-negative) patients. This raises the prospect of a benefit in HER2-low patients, where Enhertu recently scored a second-line breast cancer approval. Astra has also set out its ambition to break into earlier breast cancer uses, with first-line and periadjuvant trials set to read out this year.

Notable Enhertu trials including ovarian cancer patients

Source: OncologyPipeline & clinicaltrials.gov.