Robert Montal, MD, visiting researcher, Icahn School of Medicine, Mount Sinai Hospital, discusses biomarker findings of the phase III STORM trial (BIOSTORM), which explored adjuvant treatment with sorafenib (Nexavar) in patients with hepatocellular carcinoma (HCC).

In the analysis, researchers studied 188 HCC samples from the STORM trial who who were treated with sorafenib or placebo, Montal explains. Prognostic and predictive biomarkers were analyzed by gene expression, targeted exome sequencing of drivers, and assessment of activation of MAPK signaling and angiogenesis.

Regarding prognostic variables for recurrence-free survival (RFS), independent prognostic factors were found to be positive hepatocyte pERK staining and microvascular invasion. Additionally, positive hepatocyte pERK was associated with proliferation gene signatures, poor differentiation, and Ki-67 positivity. The results did not identify biomarkers predicting recurrence prevention to sorafenib. Biomarkers related to angiogenesis, proliferation, previously proposed gene signatures or mutations were not independently associated with recurrence or prevention with sorafenib, Montal adds. However, a multi-gene signature did correlate with an improvement in RFS.

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Robert Montal, MD, visiting researcher, Icahn School of Medicine, Mount Sinai Hospital, discusses biomarker findings of the phase III STORM trial, which explored adjuvant treatment with sorafenib (Nexavar) in patients with hepatocellular carcinoma (HCC).

Dr. Montal on Molecular Predictors of Recurrence With Adjuvant Sorafenib in HCC

Robert Montal, MD, visiting researcher, Icahn School of Medicine, Mount Sinai Hospital, discusses advancements regarding systemic therapies in the field of hepatocellular carcinoma (HCC).

Until now, the only systemic therapies that have shown survival benefits in phase III trials are the multikinase inhibitors sorafenib (Nexavar), lenvatinib (Lenvima), and regorafenib (Stivarga). However, now checkpoint inhibitors are available and have changed the landscape for several solid tumors, potentially HCC, Montal explains.

A phase II trial of nivolumab (Opdivo) have shown promising results in advanced patients with an objective response rate upwards of 20%, along with a manageable safety profile. A phase III trial is ongoing. The identification of predictive biomarkers of nivolumab, and checkpoint inhibitors overall, is a complex issue, he adds. 

Robert Montal, MD

Articles

Dr. Montal on Molecular Predictors of Recurrence With Adjuvant Sorafenib in HCC

Dr. Montal on Systemic Therapy Advancements in HCC