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EV103/#405  A phase I/II dose-escalation and efficacy/safety study of afuresertib plus sintilimab plus nab-paclitaxel in solid tumors primarily cervical cancer and endometrial cancer
  1. Lin Shen1,
  2. Rutie Yin2,
  3. Jifang Gong1,
  4. Yongsheng Li3,
  5. Ying Cheng4,
  6. Pengfei Guo5,
  7. Gaicui Qu5,
  8. Wenyue Ma5 and
  9. Yong Yue5
  1. 1Beijing Cancer Hospital, beijing, China
  2. 2West China Second University Hospital, Sichuan University, Gynecology, Chengdu, China
  3. 3Chongqing University Cancer Hospital, Chongqing, China
  4. 4Jilin Cancer Hospital, Jilin, China
  5. 5Laekna Limited, Hong Kong, China

Abstract

Introduction AKT inhibitor was reported to be a potential treatment for drug-resistant (including ICI-resistant) tumors by reducing AKT activity. Afuresertib is a pan-AKT inhibitor that showed clinical efficacy in multiple tumors. The objective of phase I part is to assess the safety and efficacy of afuresertib + sintilimab + nab-paclitaxel in advanced solid tumors, primarily in CC (cervical cancer) and EC (endometrial cancer).

Methods This is a multi-center, open-label, dose-escalation study (part I). Patients with at least 1 prior systemic anti-cancer treatment (include neoadjuvant/adjuvant), ECOG 0-2 are eligible. Efficacy evaluation is based on RECIST 1.1. Dose escalation uses Bayesian optimal interval (BOIN).

Results Up to Apr 10, 2024, 18 subjects were dosed. The most common≥ grade 3 AEs were white blood cell count decreased (27.8%), rash/rash maculo-papular (27.8%) and anemia (22.2%). Most of the AEs are manageable and reversible. Of 16 CC/EC subjects, the median prior line of systematic anti-tumor therapy was 1 (0-3), including chemotherapy, bevacizumab or ICIs. The median follow-up time was 10.0 months (1.1-21.4 months). The median PFS was 6.1 months (95% CI: 3.0-8.2 months). Out of the 13 CC/EC subjects who underwent tumor assessment, the confirmed ORR is 61.5% (95% CI: 31.6%-86.1%), DOR is 5.5 months (95% CI: 3.5-NR), DCR is 92.3% (95% CI: 64.0%-99.8%).

Conclusion/Implications The triplet regimen demonstrates a manageable safety profile and promising anti-tumor activity, as evidenced by high ORR and DCR. This study supports a further clinical study evaluating the triple regimen as a potential treatment for patients with advanced or metastatic CC and EC.

Abstract EV103/#405 Table 1

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