Josep M. Llovet, MD, Professor of Medicine at Mount Sinai Hospital, New York, commented on the findings reported by Faivre et al for The ASCO Post.

“This is the first time a TGF-β inhibitor has been clinically tested in hepatocellular carcinoma, and the drug has a good safety profile. But this is a phase II single-arm study, not randomized,” he cautioned.

He suggested that while the results were encouraging, the patient population needs to be better defined, and this extends to patients enrolled on future phase III studies. He noted that in the unselected population, the drug appears to have no benefit.

“We need a biomarker that can predict response,” he said. “[Alpha-fetoprotein] levels at baseline are not good predictors of response. It’s the patients who have decreased [alpha-fetoprotein] with treatment [who are likely to benefit]. We need a baseline biomarker.” ■

Disclosure: Dr. Llovet has served as a consultant for Bristol-Myers Squibb and has received honoraria from Bayer Pharmaceuticals and Bristol-Myers Squibb.