Abstract 222P
Background
Primary liver cancer is a major health burden globally[1]. Despite ICIs based therapy advances in unresectable hepatocellular carcinoma, additional treatments for this varied population with poor condition and multi-risk factors are needed[2-4]. Icaritin is a new modulating compound, which inhibiting the Myd88-IKK-NF-κB and IL-6/JAK2/STAT3 signaling pathways[5-9], has been approved in China for the treatment of first-line advanced HCC.
Methods
This multi-center, retrospective real world study, conducted between May 2022 and May 2024. The medical records of patients (pts) with unresectable HCC who received icaritin monotherapy or icaritin combined with PD-1/L1 and/or anti-VEGF therapy were collected. The primary endpoints was progression free survival (PFS); Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety.
Results
114 pts were enrolled, 84 pts were naïve pts and 30 pts were progression or intolerant to previous therapy. As of the data cutoff for the preliminary analysis of progression free survival (May 30, 2024). In the first line setting, the ORR for the Icaritin+ICIs+VEGF group was 38.3%, 29.41% for the Icaritin+VEGF group, and 15% for the mono-group, the mPFS was 8.25(95%CI 6.90∼13.80), 7.03 (3.68∼13.27), and 4.27 (3.12∼NE) months for each group. The post-hoc analysis of Icaritin+ICIs+VEGF group is shown that AFP≥ 400ng/mL, Child-Pugh A and prior no local therapy pts had a longer PFS. The mOS were not reached for all groups, the 12-months OS rates were 70.00%, 70.59% and 82.84%. In the second or later line setting , the ORR for the Icaritin+VEGF group was 23.08%, and 5.88% for the mono-group, the mPFS were 6.08(95%CI 2.99∼7.98), and 3.35 (2.20∼10.35) for each group. The mOS were 13.90 and NE. For the safety information, most of TRAEs were grade 1 or 2. 85.98% pts had treatment-related adverse events of any grade, of these TRAEs grade 3 or higher events occurred in 37.80% pts. No serious AEs and treatment related deaths were observed.
Conclusions
The availability of icaritin increased the option to HCC patients. No new safety signals were identified. The safety and efficacy of the icaritin were comparable.
Clinical trial identification
ChiCTR2300074565.
Editorial acknowledgement
Legal entity responsible for the study
Z. Hui, Zhejiang Cancer Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.