Minimally Invasive Procedure Combined with Lenvima and Checkpoint Blockade Shows Promise in Unresectable Liver Cancer

The use of a minimally invasive procedure — known as trans-arterial chemoembolization — plus Lenvima and a PD-1 checkpoint blockade drug proved to be safe and efficacious in patients with unresectable advanced liver cancer.

Trans-arterial chemoembolization (TACE), a procedure by which treatment is delivered directly to the liver, is safe and effective when combined with Lenvima (lenvatinib) and PD-1 checkpoint blockade — a type of immunotherapy — for the treatment of patients with advanced unresectable hepatocellular carcinoma (HCC), according to study results.

“More than 70% of hepatocellular carcinoma patients are in the intermediate or advanced stages at the time of diagnosis,” the authors explained in their abstract, which was presented at the 2022 ASCO Gastrointestinal Cancers Symposium. “There are few scientific trials to back up the safety and efficacy of TACE plus (a tyrosine kinase inhibitor) plus PD-1 antibody for the treatment of (unresectable) HCC.”

A prospective study is analyzing outcomes for patients with unresectable HCC who received TACE, Lenvima and camrelizumab and sintilimab. A control group of patients received TACE alone. While the study is still ongoing, the researchers presented the current findings they have from the study.

Study participants (92% male) had to be between the ages of 18 and 70, have HCC confirmed by histopathology or cytology, have no history of systemic treatment and have an ECOG PS score — which measures the level at which cancer and its treatments affect a person’s daily life — of 0 or 1, meaning that they had minimal limitations due to their disease.

At an average follow-up of 33.34 weeks, the conversion resection rate was 50% (19 patients), and the conversion success rate was 52.6% (20 patients). Among the 19 patients who converted to resection, five achieved a complete pathological response, meaning that there were no signs of cancer in tissues removed during the surgery. Additionally, one patient had a major pathological response, defined as 10% or less viable tumors were remaining in the resected tissue.

Further, at 48 weeks, 96.4% of the patient population was still alive, and 91.7% were still alive without their disease having gotten worse — a statistic known as progression-free survival.

There were no life threatening side effects or death from treatment, though 22 patients experienced stage 3 treatment-related side effects. Of those patients, three had their doses reduced and none stopped therapy as a result of the side effects.

The most common side effects of any severity were: abdominal pain (71%; 27 patients); aspartate aminotransferase increase, which can be a sign of liver damage (65.8%; 25 patients); and high blood pressure (57.9%; 22 patients).

This research was not the first time that TACE and immunotherapy were combined to treat liver cancer. In fact, TACE was previously studied in combination with Opdivo (nivolumab), a PD-L1 inhibitor. In this trial, more than 70% of patients responded to the therapy.

Ultimately, the authors concluded, “TACE (plus Lenvima) and PD-1 antibody (treatment) is safe and effective, and conversion resection after triple-treatment is feasible for (unresectable) HCC.”

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