The efficacy and safety of Capivasertib (AZD5363) in the treatment of patients with solid tumor: a systematic review and meta-analysis of randomized clinical trials.

Objective: To evaluate the clinical efficacy and safety of Capivasertib on patients with solid tumors.
Methods: Data from four RCTs were pooled to create a systematic review and meta-analysis focusing on Capivasertib-treated patients with solid tumor. Progression-free survival (PFS) and adverse events (AE) were the primary outcomes.
Results: A total of 540 individuals from four RCTs were included. The analysis showed that Capivasertib improved PFS for the ITT population with an HR of 0.75 (95% CI = 0.62-0.90, p = 0.002), whereas it did not show improvement in PFS of the PI3K/AKT/PTEN-altered group with an HR = 0.61 (95% CI = 0.32-1.16, p = 0.13). The analysis also showed that Capivasertib improved OS for the ITT population with an HR = 0.61 (95% CI = 0.47-0.78, p = 0.0001). For safety, four studies were included; statistical differences between Capivasertib and placebo were found in discontinuation of Capivasertib due to toxicity or AE (RR = 2.37, 95% CI = 1.37-4.10, p = 0.002).
Conclusion: Capivasertib plus chemotherapy or hormonal therapy combination has shown promising antitumor efficacy and promising safety profile in the treatment of individuals with solid tumor.