Abstract 201P
Background
The single-arm, multicenter, phase II NeoLEAP-HCC study (NCT05389527) was conducted to evaluate the efficacy and safety of pembrolizumab plus lenvatinib as perioperative treatment in patients (pts) with resectable hepatocellular carcinoma (HCC). We have reported that the major pathological response (MPR) rate was 37.8%. Here, we report the updated perioperative efficacy and safety results after an additional 6 mo of follow-up.
Methods
Resectable HCC pts with a high risk of recurrence and naïve to systemic therapy received pembrolizumab 200mg q3w and lenvatinib 12 or 8 mg qd for 3 cycles followed by resection. Pembrolizumab and lenvatinib were given for up to 12 months after resection. The primary endpoint was MPR. Secondary endpoints were complete pathological reactions (pCR), objective response rate (ORR, by RECIST v1.1 and mRECIST), disease-free survival (DFS), overall survival (OS), and safety. Data cutoff was June 15, 2024.
Results
A total of 43 pts were enrolled in the study. Forty pts completed neoadjuvant therapy and underwent R0 resection. Thirty-seven pts were pathologically confirmed HCC and included in the DFS analysis. With a median follow-up time after surgery of 11.9 mo (range, 7.4-17.9), 12 of the 37 HCC pts had postoperative recurrence, of which 9 (75%) had only intrahepatic recurrence and 3 (25%) had both intrahepatic and extrahepatic recurrence. The median DFS was not reached (95%CI, 10.2- not estimable [NE]). The 1-year DFS rate was 60.0%. The median DFS of pts who achieved MPR was numerically improved compared with those who did not achieve MPR (NE vs. 11.6 months, HR 0.37 (95% CI, 0.11-1.33), P=0.13). Other subgroup analyses showed that pts with early BCLC stage at enrollment and those with radiographic response (mRECIST) also tended to have a DFS benefit. Perioperative safety was evaluated, and no unexpected safety signals were observed.
Conclusions
Perioperative pembrolizumab and lenvatinib appears to be safe and beneficial in DFS in pts with resectable HCC. The results support further investigation of perioperative immunotherapy for HCC.
Clinical trial identification
NCT05389527, release date: 2022-05-20.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Supported in part by a research grant from Investigator-Initiated Studies Program of MSD.
Disclosure
H. Sun: Financial Interests, Institutional, Invited Speaker: AstraZeneca, Bayer, BeiGene, Eisai, Hengrui, Innovent, MSD, Roche, TopAlliance, Zelgen; Financial Interests, Institutional, Funding, research grants: Eisai, Innovent, Roche, MSD. X. Zhu: Financial Interests, Institutional, Invited Speaker: Beigene, Eisai, Hengrui, Innovent, MSD, Roche. All other authors have declared no conflicts of interest.