Second-Line Sintilimab Plus Lenvantinib Demonstrates Efficacy, Safety in Intrahepatic Cholangiocarcinoma

Combination treatment with sintilimab and lenvatinib was found to be an effective and tolerable second-line regimen for patients with advanced intrahepatic cholangiocarcinoma, according to a multicenter observational study..

Study authors wrote, “Recently, the potential synergistic efficacy of anti-angiogenesis combined with immune checkpoint inhibitor has been demonstrated in cancer treatment. In addition, the success of the combination of immune checkpoint inhibitors, such as sintilimab with a bevacizumab biosimilar or pembrolizumab plus lenvatinib have been reported in unresectable hepatocellular carcinoma.”

The study included 41 patients with advanced, unresectable intrahepatic cholangiocarcinoma who had progressed after or were intolerable to first-line chemotherapy between October 31, 2019, and October 31, 2021. All patients received combination treatment with sintilimab and lenvatinib.

The primary end point of the study was time to progression (TTP). Secondary end points included tumor objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity.

At the data cutoff date of December 31, 2021, the median follow-up duration was 12.1 months. Of the 41 patients, 28 (68.3%) had disease progression and the median TTP was 6.6 months (95% CI, 4.9 to 8.3). Those patients with lymph node metastasis had a significantly worse median TTP at 6.2 months (95% CI, 3.5 to 8.9) compared to 13.8 months (95% CI, 6.1 to 21.5; P = .031). For those patients with a baseline PD-L1 TPS ≥10%, the median TTP was 16.9 months (95% CI, 7.5 to 26.3) which was significantly prolonged when compared to patients with a baseline PD-L1 TPS <10% (4.1 months; 95% CI, 1.8 to 6.4; P = .001).

“The combination regimen showed encouraging clinical benefit in real world, longer than most reported studies,” study authors concluded. “The combination is well-tolerated and showed encouraging efficacy, which might be more effective in patients with PD-L1 TPS over 10%. Further investigation of this current regimen in prospective multi-center clinical practice is warranted.”

Source:

Ding X, Li G, Sun W, et al. Sintilimab combined with levatinib for advanced intrahepatic cholangiocarcinoma in second-line setting — A multi-center observational study. Front Oncol. Published online July 14, 2022. doi:10.3389/fonc.2022.907055