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Abstract
Introduction The aim of AK001 trial (ChiCTR2300076740) is to investigate the efficacy of cadonilimab in combination with disitamab vedotin or nab-paclitaxel in the treatment of recurrent or metastatic cervical cancer. Here, we report the preliminary results of AK001.
Methods Patients with recurrent or metastatic cervical cancer who had progressed after 1-3 lines of chemotherapy were eligible in this study. The included patients were divided into two independent cohorts according to the HER2 immunohistochemistry (IHC) expression: cohort I with a HER2 IHC 1+~3+ and cohort II with HER2 0. Patients in Cohort I were treated with cadonilimab and disitamab vedotin biweekly while those in cohort II were treated with cadonilimab and nab-paclitaxel triweekly. The primary endpoint of the study was objective response rate (ORR). A Simon 2-stage design was utilized.(see Chart 1)
Results Presently 17 patients have been enrolled in this study including 10 evaluable patients (4 in cohort I and 6 in cohort II), the median follow-up was 4.1 (95%CI 3.2-5.2) months. Baseline characteristics were shown in table 1. For cohort I, the ORR and DCR were 50% (2/4) and 75% (3/4). For cohort II, the ORR and DCR were 66.7%(4/6) and 88.3% (5/6). Toxicity was tolerable in both cohorts.
Conclusion/Implications Our preliminary results provide an encouraging solution for the second-line treatment of recurrent or metastatic cervical cancer based on HER2 expression. Cadonilimab plus disitamab vedotin may emerge as a novel effective combination for the treatment of HER2 positive cervical cancer in the future. Data will be updated further.
Baseline characteristics