Real world evidence for patients with advanced and metastatic pancreatic cancer treated with sacituzumab govitecan: A retrospective trial in China.

Abstract

e16412 Background: Pancreatic cancer is a malignancy with poor prognosis and lack of effective therapeutic targets. Chemotherapy remains the foundation of treatment for advanced and metastatic pancreatic cancer. Notably, in cases where standard treatment has failed, the median overall survival typically does not exceed 3 months. Consequently, there are still significant unmet clinical needs for the treatment of advanced pancreatic cancer. Methods: Patients with refractory advanced or metastatic pancreatic cancers received intravenous SG (10 mg/kg) on days 1 and 8 of 21-day cycles either alone or in combination with other anti-tumor treatment regimens until disease progression or unacceptable toxicity. Endpoints included safety and with investigator-evaluated objective response rate (ORR per RECIST 1.1), duration of response, clinical benefit rate, progression-free survival. Results: A total of 19 advanced or metastatic pancreatic cancer patients from across China, enrolled between January 2023 and June 2024, were included in this study.The follow-up period was concluded on December 31, 2024. The median PFS for these 19 patients was 3.15 months.Owing to the patients' physical conditions, 7 patients received low-dose SG treatment (less than 75% of the standard dose). Specifically, three of these patients were on a combination regimen.The median PFS in the SG monotherapy group was 3.05 months (95% confidence interval [CI] = 0.8-7.0, P = 0.4), whereas in the combined treatment group, it was 3.5 months (range: 1.0-9.0 months). In the low-dose group, the median PFS was 2.25 months (1.0-3.0 months), and in the non-low-dose group, it was 3.45 months (95% CI = 0.8-7.0 months, HR = 0.14, P = 0.08). Seven patients underwent Trop - 2 immunohistochemistry testing, and all exhibited moderate to high expression of Trop - 2. The median PFS for this subgroup was 3.7 months（95% CI = 2.0-3.8 months,）. Multivariate analysis identified advanced-stage disease at initial diagnosis (hazard ratio [HR] = 0.17, P = 0.01) and an ECOG score of 0 - 1 (HR = 0.19, P = 0.008) as independent predictors of disease progression. Among the 15 patients whose efficacy could be evaluated, the ORR was 20%.Regarding safety, hematological adverse events were observed in 11 out of 19 patients. Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases. No novel adverse events were observed during this study. Conclusions: This study demonstrated the first real-world investigation in the Chinese population exploring the efficacy and safety of SG for treating advanced or metastatic pancreatic cancer patients. Among patients who failed standard treatment, SG-based regimen showed satisfactory efficacy and safety profiles. SG-based regimens seem to represent a potential new therapeutic option for advanced pancreatic cancer patients with good performance status.