Sacituzumab Govitecan for Recurrent Endometrial Cancer
Publication Title: A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer
Summary
- Question
- This study examined the efficacy and safety of sacituzumab govitecan, a Trop-2–directed antibody-drug conjugate, in patients with recurrent endometrial cancer, including those with aggressive subtypes such as serous carcinoma and carcinosarcoma. The researchers aimed to determine its objective response rate (ORR) and explore secondary outcomes such as clinical benefit rate, duration of response, progression-free survival, and overall survival.
- Why it Matters
- Endometrial cancer is the most common gynecologic cancer in the United States, and treatment options for patients whose disease progresses after chemotherapy and immunotherapy remain limited. Aggressive forms of this cancer, such as serous carcinoma and carcinosarcoma, are particularly challenging to treat. Sacituzumab govitecan has shown promise in other cancers and may offer a new option for these patients, addressing a critical need for more effective therapies.
- Methods
- This phase II, single-center, open-label study enrolled 50 patients with recurrent endometrial cancer who had undergone at least one prior line of therapy. Participants received sacituzumab govitecan at a dose of 10 mg/kg on days 1 and 8 of a 21-day cycle. The study included two stages: the first enriched for patients with tumors expressing Trop-2 (a protein linked to poor prognosis), while the second included all eligible patients regardless of Trop-2 levels.
- Key Findings
- The objective response rate was 28%, with 4% of patients achieving complete responses and 24% achieving partial responses. The median duration of response was 9.3 months. The clinical benefit rate, which includes stable disease lasting at least six months, was 52%. Median progression-free survival was 5.5 months, and median overall survival was 17.5 months. Responses were observed across tumor types, including serous carcinoma and endometrioid tumors, with notable activity in both subtypes.
- Implications
- These findings suggest that sacituzumab govitecan could be an effective treatment option for patients with recurrent endometrial cancer, including those with aggressive tumor subtypes. Its efficacy is notable compared with historical outcomes of standard single-agent chemotherapies. Additionally, its manageable safety profile may make it a viable choice for heavily pretreated patients.
- Next Steps
- The authors recommend further studies, including randomized trials, to confirm these findings and to evaluate the relationship between Trop-2 expression and treatment outcomes. Future research could also explore combining sacituzumab govitecan with immunotherapy to enhance its efficacy.
- Funding Information
- This research was supported by Gilead Sciences, Inc., which provided the study drug and funding for the trial. Yale University also provided funding and support for this research.
Full Citation
Santin A, Roque D, Siegel E, Ettorre V, Greenman M, McNamara B, Papatla K, Kailasam A, Buza N, Clark M, Hui P, Dottino P, Ratner E, Bellone S. A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer. Clinical Cancer Research 2026, 32: 3169-3178. PMID: 42132892, PMCID: PMC13430211, DOI: 10.1158/1078-0432.ccr-26-0144.
Authors
Alessandro Santin, MD
First AuthorProfessor of Obstetrics, Gynecology, and Reproductive Sciences
Stefania Bellone, PhD
Last AuthorAssociate Research Scientist in Obstetrics, Gynecology, and Reproductive Sciences