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Nexavar/resminostat shows efficacy for HCC

In the SHELTER clinical trial, patients with hepatocellular carcinoma treated with Nexavar in combination with resminostat had efficacious treatment rates vs. resminostat alone, according to data published in the Journal of Hepatology.

Researchers assigned 38 patients with HCC to one of four dose levels (between 200 and 600 mg) of resminostat (4SC-201, 4SC AG), an oral pan–histone-deacetylase inhibitor, plus Nexavar (sorafenib, Bayer HealthCare; between 400 and 800 mg) daily and compared treatment results to 19 patients who received resminostat alone for 12 weeks. All patients had radiologically confirmed HCC progression from previous therapy with sorafenib alone.

Overall, patients treated with the combination regimen had higher progression-free survival rates after 12 weeks of treatment (62.5%) compared with patients treated with resminostat alone (12.5%). In addition, the combination-treated group had higher time to progression rate (6.5 months) and overall survival (8 months) compared with the resminostat alone group (1.8 months, 4.1 months).

Analysis showed zinc finger protein 64 (ZFP64) baseline expression in blood cells correlated with overall survival.

Common adverse events were gastrointestinal disorders, thrombocytopenia and fatigue. Sorafenib and Child-Pugh score did not affect the pharmacokinetic characteristics of resminostat, according to the research.

“The combination of sorafenib and resminostat in HCC patients was safe and showed early signs of efficacy. … A prognostic and potentially predictive role of ZFP64 for treatment with resminostat should be further investigated in HCC and possibly other cancer indications,” the researchers concluded. – by Melinda Stevens

Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures at the time of publication.