Sacituzumab govitecan-hziy (Trodelvy) elicited an objective response rate (ORR) of 35% in patients with platinum-resistant ovarian cancer (PROC), according to data from a single-institution phase 2 study (NCT06028932) presented at the
Findings showed that all responses were partial, and stable disease was achieved in 40% of patients, translating to a disease control rate of 75%. At a median follow-up of 9 months, the median progression-free survival (PFS) was 8.0 months (95% CI, 3.8-14.8) among evaluable patients (n = 20), and the median overall survival (OS) had not yet been reached.
“Sacituzumab govitecan has encouraging efficacy for PROC with manageable toxicity,” lead study author Alessandro D. Santin, MD, of Yale School of Medicine and Yale Cancer Center in New Haven, Connecticut, and colleagues wrote in the poster. “Further studies are warranted.”
Patients with PROC have few therapeutic options, and more than 60% of high-grade serous ovarian cancers overexpress Trop-2 at 2+ or greater by immunohistochemistry (IHC), providing a rationale for Trop-2–directed therapy.
Sacituzumab govitecan is an antibody-drug conjugate consisting of a Trop-2–directed antibody conjugated with SN-38, the active metabolite of irinotecan. Other novel agents are being investigated in this setting, including the oral CDK2 inhibitor INCB123667, which advanced to the phase 3 MAESTRA 2 trial (NCT07214779) after demonstrating early activity in cyclin E1–overexpressing PROC,2 and the antibody-drug conjugate mocertatug rezetecan, which produced rapid, deep responses in platinum-resistant ovarian and recurrent/advanced endometrial cancer.3
The trial was a single-institution, open-label phase 2 study that enrolled patients with PROC and an ECOG performance status of 0 or 1.1
Patients received sacituzumab govitecan at 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle until prohibitive toxicity or disease progression. The primary end point was ORR by RECIST 1.1 criteria; secondary end points included PFS, OS, and safety. Trop-2 membrane H-scores, calculated on a scale of 0 to 300, were also assessed and ranged from 85 to 260 across the study population.
Among the 20 enrolled patients, the median age was 67 years (range, 45-84), and patients had received a median of 3 prior lines of therapy (range, 1-8). Most patients had serous histology (75%), followed by clear cell (15%), endometrioid (5%), and carcinosarcoma (5%). An ECOG performance status of 0 was reported in 80% of patients, and 85% had stage III or IV disease.
The most common grade 3 or 4 treatment-emergent adverse effects (TEAEs) included neutropenia (n = 15), hypokalemia (n = 3), and anemia (n = 2), with no new safety signals reported.
Investigators recorded 14 serious AEs, comprising 9 at grade 3 and 5 at grade 4; no treatment-related deaths occurred.
