751PAnlotinib for advanced hepatocellular carcinoma: Interim results from the phase II ALTER0802 study

Abstract Background The available treatment for advanced hepatocellular carcinoma (aHCC) remained limited in 2016 when our study was initiated. The phase II, ALTER0802 study (NCT02809534) evaluated anti-tumor activity and safety of anlotinib, a small molecular tyrosine kinase inhibitor (TKI), in patients (pts) with aHCC. Methods Pts aged 18-75 yrs with histologically/cytologically confirmed unresectable or metastatic HCC or prior progression/intolerance on standard therapy were enrolled if they were Child-Pugh ≤8 and ECOG PS ≤ 1. Pts were divided into two cohorts: 1. those who did not receive prior systemic chemo or targeted therapy; 2. those who have received prior TKI treatment. Pts received anlotinib 12 mg, 2 weeks on/ 1 week off, until disease progression or unacceptable adverse events (AEs). The primary endpoint was progression-free survival rate at 12 weeks (PFR12w); ORR, DCR, TTP, OS, PFR24w, and safety were secondary endpoints. Results At the date of the interim analysis (Mar 7, 2019), 43 pts were enrolled (26 and 17 pts for cohort 1 and 2, respectively). In cohort 1, PFR12w was 80.8% (95%CI, 67.0-97.4); median OS (mOS) was 10.8 mo (months; 95%CI, 8.0-NE [not estimated]); median TTP (mTTP) was 5.5 mo (95%CI, 4.7-NE); DCR was 84.6% (95%CI, 65.1-95.6). In cohort 2, PFR12w was 58.8% (95%CI, 39.5-87.6); mOS was not reached; mTTP was 4.01 mo (95%CI, 1.94-11.4); DCR was 76.5% (95%CI, 50.1-93.2). Other outcomes for both cohorts were presented in the table. Overall, treatment related AEs (TRAEs) were limited to mild hypertention, hand-foot skin reaction and bone and muscular pain. No grade IV or above AEs occurred. Table . 751P Cohort 1 (n = 26) Cohort 2 (n = 17) ORR (n) 3.85% (1) 5.9% (1) CR (%) 0 0 PR (%) 1 (3.85) 1 (5.9) SD (%) 21 (80.8) 12 (70.6) PD (%) 4 (15.4) 4 (23.5) PFR24w (95%CI) 43.2% (26.5-70.6) 22.1% (10.5-55.8) Conclusions In this interim analysis, anlotinib showed durable anti-tumor activity and manageable toxicity in pts with aHCC regardless of in the first or second line treatment. Clinical trial identification NCT02809534. Legal entity responsible for the study Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Funding Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Disclosure All authors have declared no conflicts of interest.