A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with advanced hepatocellular carcinoma (aHCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.

The retrospective analysis, published in Journal of Cancer Research and Clinical Oncology, sought to demonstrate the clinical benefits of sintilimab plus bevacizumab as a first-line treatment as well as the cost-effectiveness of using a bevacizumab biosimilar in a real-world setting. The study served to add to the results of the ORIEND-32 study, the first large-scale, multicenter, open-label, randomized. controlled trial to evaluate the clinical benefit and safety of a programmed death-1 (PD-1) inhibitor plus anti–vascular endothelial growth factor (VEGF) therapies in aHCC. Sintilimab, also known as Tyvyt, is a PD-1 inhibitor, and all bevacizumab products are anti-VEGF therapies.

“The combination of sintilimab and bevacizumab biosimilar highlighted the favorable clinical benefit and tolerability in a real clinical setting…. This combination regimen provides a novel and attractive alternative treatment choice for these aHCC patients,” the authors noted.

The researchers reviewed clinical data from 112 patients with aHCC who received sintilimab plus bevacizumab as first-line treatment in Chongqing University Cancer hospital between July 2021 and December 2022. The primary end points were overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and adverse event (AE) rates. Survival curves were grafted using the Kaplan-Meier method, and a Markov model was developed to evaluate the economic outcomes of sintilimab plus bevacizumab biosimilar.

For the analysis, 68 patients were included in the study, most of whom were male (n = 59; 86.8%). The average (SD) age was 55 (11.4) years, and the mean diameter of each patients’ largest tumor nodule was 8.2 (5.9) cm at baseline.

All enrolled patients were administered sintilimab plus a biosimilar and were assessed for treatment response and safety every 6 to 12 weeks until death or the cutoff date (January 10, 2023). Sintilimab was administered intravenously at 200 mg every 3 weeks, which was determined based on body weight. The standard dose of the bevacizumab biosimilar used was 15 mg/kg.

At the time of their best response status, no patients achieved complete response according to RECIST 1.1 criteria. Partial response was observed in 8 patients and stable disease was found in 51 patients; 9 patients experienced disease progression (ORR, 11.8%; disease control rate, 86.8%). The median OS was 344.0 (range, 168.8-419.2) days, and the median PFS was 238.0 (range, 174.6-301.4) days.

Overall, 35 patients (51.5%) reported a treatment-related AE, 9 of whom reported an AE of grade 3 or higher (13.2%). The most common AEs were elevated levels of γ-glutamyltransferase (n = 33; 48.5%), alanine aminotransferase (n = 32; 47.1%), and aspartate aminotransferase (n = 31; 45.6%), and decreased lymphocytes (n = 26; 38.2%). Hypertension (n = 1; 1.5%) and interstitial pneumonia (n = 1; 1.5%) were the most common AEs that resulted in treatment discontinuation.

Base-case results from the cost-effectiveness analysis exhibited that use of a bevacizumab biosimilar resulted in 1.97 quality-adjusted life years (QALYs) and 2.92 overall life years, with an accompanying cost of $35,018 in savings.

“HCC causes large social and economic burden to patients and government in China…. The present analysis initially came to the conclusion that sintilimab plus bevacizumab biosimilar was cost-effective as a first-line therapy for aHCC, especially in the implementation of diagnosis related groups payment. In addition, these drugs were affordable and available from the Chinese payer perspective with [willingness to pay],” the authors wrote.

The study has some limitations, including the retrospective and observational design, short follow-up period, and the cost-effectiveness analysis only pertaining to direct medical costs (excluded accommodation cost, traffic and board expenses).

Reference

Zeng X, Jia Y, Chen H, et al. A real‐world analysis of survival and cost‐effectiveness of sintilimab plus bevacizumab biosimilar regimen in patients with advanced hepatocellular carcinoma. J Cancer Res Clin Oncol. 2023;149(11):9213-9219. doi:10.1007/s00432-023-04775-2

Source:- CenterForBiosimilar