Introduction/BackgroundDisitamab Vedotin (RC48) is a HER2-targeted ADC. A phase II, open-label, multicenter basket design study (NCT04965519) is currently underway to evaluate the effectiveness and safety of RC48 monotherapy in the treatment of HER2-expressing gynecologic malignancies.MethodologyThe cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+. The treatment regimen consists of RC48 monotherapy administered at a dose of 2 mg/kg Q2W. The primary endpoint is the ORR(IRC). Secondary endpoints include ORR(INV), DoR, DCR, PFS, OS, and safety.ResultsFrom January 24, 2022, to April 30, 2023, 17 cervical cancer patients were enrolled. The median age was 53 years (range: 35–66). Most patients (58.8%) had a baseline ECOG performance score of 1. Ten patients had a primary FIGO stage of IIB or higher. 13(76.5%) patients had squamous cell carcinoma, and 4 (23.5%) had adenocarcinoma. Among the 16 efficacy evaluable patients, the cORR was 43.8% (7/16), the mDoR was 5.45 months, and the median time to response was 1.5 months. The DCR was 87.5% (14/16), and the mPFS was 4.17 months . Among all 17 cervical cancer patients, the most common treatment-related adverse events (TRAEs) included decreased white blood cell count (53%), anemia (53%), increased aspartate aminotransferase (47%). Grade 3 or higher TRAEs included decreased neutrophil count (16%), increased gamma-glutamyl transferase (11%). Two patients (11.8%) experienced SAEs, and there were no deaths related to RC48.ConclusionRC48 demonstrates manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it a promising new treatment for HER2- expressed cervical cancer.DisclosuresThis trial is sponsored by RemeGen Co., Ltd. All authors are investigators of this trial except Jianmin Fang. Jianmin Fang is the CEO of RemeGen Co., Ltd. COI are uploaded.
16075 Background: To investigate the expression of P - gp,Bcl-2 and VEGF in epithelial ovarian carcinoma as well as their significance. Methods: Expression of P- gp,Bcl-2 and VEGF were examined in 72 epithelial ovarian carcinoma by immunohistochemisty (method of S - P) . Results: The positive expressions of P - gp,Bcl-2 and VEGF in patients with ovarian carcinoma were 51.4%,54.2%,56.9% respectively .Compared with those in ovarian benign tumors and normal controls, such expression level were significantly higher ( P < 0.05). The expression of P - gp was positively correlated with the expression of VEGF( P <0. 05) while the expression of VEGF was positively correlated with the expression of Bcl-2 ( P <0. 05). Univariate analysis showed worse disease-free survival in the patients with positive expression of P-gp or VEGF than in those with negative expression of P -gp or VEGF( P < 0. 05). Multivariate analysis of clinical and pathological data by Cox-regression method showed that the expression of P - gp or VEGF and co- expression of these three indexes were correlated with poor prognosis. Conclusions: Over-expression of P - gp,Bcl-2 and VEGF is correlated with drug resistance of clinical chemotherapy and survival rate in ovarian cancer . To examine these 3 indexes in ovarian cancer is helpful to evaluate response to clinical chemotherapy as well as to predict the prognosis. No significant financial relationships to disclose.