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Datopotamab Deruxtecan Shows Promise for Unresectable Advanced Endometrial and Ovarian Cancers

Results From the TROPION-PanTumor03 Trial

According to results from the TROPION-PanTumor03 study, datopotamab deruxtecan monotherapy showed encouraging efficacy with a manageable safety profile among patients with recurrent endometrial or ovarian cancer.

These results were first presented by Ana Oaknin, MD, Vall d’Hebtron Institute of Oncology, Barcelona, Spain, at the 2024 European Society for Medical Oncology Congress.

The multicenter, open-label phase 2 TROPION-PanTumor03 study examines the efficacy and safety of Trop2-directed antibody-drug conjugate datopotamab deruxtecan, as monotherapy and in combination, among several tumor types in independent cohorts. These results are from the cohorts enrolling patients with unresectable advanced/metastatic endometrial or high-grade ovarian, fallopian tube or primary peritoneal cancer who had progressed after ≥1 line of platinum-based chemotherapy and were unselected for Trop2 expression. Patients received 6 mg/kg of datopotamab deruxtecan monotherapy once every 3 weeks. The primary end points were objective response rate (ORR) and safety/tolerability.

At the time of data cutoff, there were 40 patients in the endometrial cancer cohort and 25 in the ovarian cancer cohort who had received datopotamab deruxtecan. Among patients with endometrial cancer, the confirmed ORR was 27.5%, with 1 complete response, 10 patial response, and a disease control rate of 85.0%. The duration of response was not yet reached and median progression-free survival (PFS) was 6.3 months. Among patients with ovarian cancer, the confirmed ORR was 42.9%, with a disease control rate of 91.4%. The duration of response was 5.6 months and the median PFS was 5.8 months.

Grade ≥3 treatment-related adverse events were reported in 42.5% of patients in the endometrial cohort and 45.7% in the ovarian cohort. There was 1 instance of adjudicated drug-related interstitial lung disease in each cohort, both grade 3. No treatment-related adverse events led to death.

Dr Oaknin concluded, that datopotamab deruxtecan monotherapy “demonstrated encouraging efficacy and a manageable safety profile in [patients] with recurrent endometrial or ovarian cancer.”


Source:

Oaknin A, Ang JE, Rha SY, et al. Datopotamab deruxtecan (Dato-DXd) in patients with endometrial (EC) or ovarian cancer (OC): Results from the phase II TROPION-PanTumor03 study. Presented at 2024 ESMO Congress. September 13-17, 2024. Abstract 714MO