Adjuvant therapy with atezolizumab (Tecentriq) and bevacizumab (Avastin) increased recurrence-free survival of patients with hepatocellular carcinoma (HCC) following surgical resection or ablation, according to the results from a Phase III trial.
The results of the IMbrave050 clinical trial were presented at the AACR Annual Meeting 2023, held April 14-19.
The mainstays of curative therapies for early-stage HCC include surgical resection and thermal ablation, a treatment that destroys the cancer cells with heat or cold. However, the risk of recurrence reaches 70-80% five years after resection or ablation with curative intent.
Presenting author Pierce Chow, Senior Consultant Surgeon at National Cancer Centre Singapore and Singapore General Hospital, and Professor and Program Director at Duke-NUS Medical School, Singapore, said: “Due to the lack of proven adjuvant therapy strategies for HCC, patients who are treated with surgical resection or thermal ablation with curative intent tend to have significantly higher recurrence rates and shorter overall survival than patients with other types of cancer, for example, colorectal and breast cancer treated with similar curative intent. The positive results of IMBrave050 address this huge and urgent unmet clinical need in HCC.”
The IMbrave050 trial
The randomised, controlled Phase III IMbrave050 trial was designed to investigate the efficacy of an adjuvant treatment combination of the checkpoint inhibitor atezolizumab and the targeted therapy bevacizumab in delaying or preventing recurrence compared with active surveillance.
The trial enrolled patients with HCC who were at high risk of recurrence following tumour resection or ablation, based on criteria such as size and number of tumours, presence of cancer cells within the lumen of blood and/or lymphatic vessels, and tumour grade.
According to the results of an interim analysis conducted after a median follow-up of 17.4 months, the trial met its primary endpoint, and the combination therapy significantly increased IRF-RFS.
Patients who received the combination treatment had their risk of recurrence or death reduced by 28% compared with patients in the active surveillance arm. At this timepoint, the median IRF-RFS was not reached for either arm.
“IMbrave050 is a landmark study and the first to demonstrate an efficacious adjuvant therapy for patients with HCC who have undergone surgical resection or ablation,” Chow said. “These results have established a benchmark in adjuvant therapy for HCC and have the potential to be practice-changing.”
Chow added that better clinical outcomes following treatment with this adjuvant regimen might also have an impact on the clinical indications for surgical resection and ablation in HCC.
“Currently, surgery is not offered to many patients with potentially resectable disease if rapid recurrence is expected based on tumour burden or the presence of vascular invasion,” he said. “The availability of an efficacious adjuvant therapy may lead to a reassessment of which patients may benefit from surgical resection.”