Dosing begins in trial testing Enhertu for ovarian cancer
Study will evaluate if maintenance therapy helps slow disease progression
Dosing has begun in a Phase 3 clinical trial testing Enhertu (trastuzumab deruxtecan) as a maintenance treatment for certain people with ovarian cancer.
The DESTINY-Ovarian01 trial (NCT06819007) aims to enroll 582 women with advanced ovarian cancer whose tumors express a protein called HER2. To be eligible, patients must have already completed standard first-line treatment involving platinum-based chemotherapy in combination with bevacizumab, a medication that inhibits the growth of new blood vessels in tumors. Bevacizumab is sold under the brand name Avastin, among others.
All participants in the trial will receive maintenance therapy with bevacizumab, given by infusion into the bloodstream every three weeks. Some participants will also receive Enhertu every three weeks, while others will receive bevacizumab only. The study’s main goal is to determine whether the addition of Enhertu can help delay disease progression. The trial is recruiting participants at more than 100 sites worldwide.
“Given the important role first-line maintenance therapy can play in disease control, we have initiated this first Phase 3 trial in ovarian cancer to evaluate whether ENHERTU combined with bevacizumab could become a new maintenance strategy for patients with HER2-expressing advanced high-grade epithelial ovarian cancer,” Abderrahmane Laadem, MD, head of late-stage oncology clinical development at Daiichi Sankyo, said in a company press release.
Daiichi, which is sponsoring the Phase 3 study, is developing and commercializing Enhertu in partnership with AstraZeneca. The therapy is approved in the U.S. as a treatment for certain HER2-positive breast, lung, and stomach cancers.
Enhertu contains antibody targeting key protein
Ovarian cancer is a form of gynecological cancer marked by the abnormal growth of cells in or near the ovaries. First-line treatment involves chemotherapy and, where feasible, surgery, but most people with advanced ovarian cancer will experience a recurrence where the tumor grows back following first-line treatment. The goal of maintenance therapy is to prevent the tumor from recurring.
HER2 is a protein receptor that helps drive the abnormal growth of cells in certain types of cancer. Enhertu contains an antibody targeting this protein that’s attached to a toxic molecule; the goal is for the antibody to deliver the toxin directly to cancer cells, killing them.
Enhertu is also conditionally authorized for people with advanced HER2-positive solid tumors who have received initial treatment and have no satisfactory alternative options. The conditional approval was supported by a Phase 2 study, DESTINY-PanTumor02 (NCT04482309), which tested Enhertu in people with various types of HER2-positive solid tumors. Among 40 ovarian cancer patients treated with the therapy, nearly half (45%) had an objective response, essentially meaning their tumor got smaller.
“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,” Laadem said.
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