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A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai, the company developing the therapy.

Nivolumab (Opdivo) was given an accelerated approval by the FDA for the treatment of patients with hepatocellular carcinoma following prior treatment with sorafenib (Nexavar). The approval was granted for patients regardless of their PD-L1 status. 

While currently-approved treatments for HCC are typically associated with responses rates of 10% or less, findings presented at the 11th Annual Conference of the ILCA, BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), induced an overall response rate of 16% (95% CI, 6-31) in patients with FGF 19 IHC-positive HCC.

Multidisciplinary findings across the field of hepatocellular carcinoma will be showcased at the 11th International Liver Cancer Association Annual Conference on September 15 to 17 in Seoul, South Korea. Abstracts already under discussion at this year’s ILCA conference include pivotal research on VGEF inhibitors, immunotherapy regimens, and biomarkers.

Hepatocyte pERK-positive immunostaining and microvascular invasion were independent prognostic factors of recurrence-free survival for patients with hepatocellular carcinoma treated with adjuvant sorafenib. According to an analysis of the phase III STORM study presented at the 11th International Liver Cancer Association Annual Conference, a predictive biomarker for recurrence was not uncovered.

According to updated phase III results presented at the 11th Annual International Liver Cancer Association Conference, first-line therapy with Lenvatinib in the frontline setting continued to be noninferior in overall survival and achieve significant improvements in progression-free survival, time to progression, and objective response rate versus sorafenib for patients with unresectable hepatocellular carcinoma

Direct acting antivirals, a novel, oral hepatitis C therapy, is associated with a high response rate. DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. However, this treatment has been replaced by interferon-based therapy for patients with hepatitis C.

According to findings presented at the 11th Annual Conference on the International Liver Cancer Association in Seoul, South Korea, BLU-554 induced an overall response rate of 16% in patients with FGF 19 immunohistochemistry-positive hepatocellular carcinoma. BLU-554 is a potent and highly selective inhibitor of fibroblast growth factor receptor 4.

David J. Pinato, MD, PhD, NIHR Academic Clinical Lecturer in Medical Oncology, resident, Royal Brompton Hospital and Imperial College London, discusses an analysis of intra-tumor heterogeneity in the regulation of immune-tolerogenic pathways in primary and metastatic hepatocellular carcinoma (HCC).