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Approval-Inciting Data in Hepatocellular Carcinoma

Insights From: R. Kate Kelley, MD, UCSF Helen Diller Family Comprehensive Cancer Center; Josep Llovet, MD, PhD, Icahn School of Medicine at Mount Sinai; Masatoshi Kudo, MD, PhD, Kindai University; Arndt Vogel, MD, PhD, Hannover Medical School
Published: Friday, Jul 12, 2019



Transcript:

Masatoshi Kudo, MD, PhD: Since 2007, for 10 years, many clinical trials failed. The only successful trial for 10 years was the REFLECT trial, and that proved 2 very important points. One is weight-based dosing. For body weight greater than 60 kg, 12 mg is given; and for body weight less than 60 kg, 80 mg was given. So that was 1 point.

Another point is, no inferiority design, so the noninferiority margin was very strict, 1.08. And the result median OS [overall survival] of lenvatinib was 13.6 months, and 12.3 months in sorafenib. So the upper margin of 95% CR [complete response] was 1.06, which means the trial was positive. And actually, there was AFP [α-fetoprotein] imbalance favoring sorafenib. So if we adjusted the AFP imbalance, lenvatinib was superior to sorafenib. So lenvatinib is a very good agent as far as prolonging OS, and antitumor activity is very better than sorafenib. Like I said, the response rate is 40.6% versus 10% in sorafenib; and the PFS [progression-free survival], 7.4 months versus 3.7 months. So antitumor activity is very good.

And regarding adverse events, the hand-foot skin reaction is less as compared with sorafenib, and diarrhea is also less. And quality of life is better than with sorafenib. So it
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Transcript:

Masatoshi Kudo, MD, PhD: Since 2007, for 10 years, many clinical trials failed. The only successful trial for 10 years was the REFLECT trial, and that proved 2 very important points. One is weight-based dosing. For body weight greater than 60 kg, 12 mg is given; and for body weight less than 60 kg, 80 mg was given. So that was 1 point.

Another point is, no inferiority design, so the noninferiority margin was very strict, 1.08. And the result median OS [overall survival] of lenvatinib was 13.6 months, and 12.3 months in sorafenib. So the upper margin of 95% CR [complete response] was 1.06, which means the trial was positive. And actually, there was AFP [α-fetoprotein] imbalance favoring sorafenib. So if we adjusted the AFP imbalance, lenvatinib was superior to sorafenib. So lenvatinib is a very good agent as far as prolonging OS, and antitumor activity is very better than sorafenib. Like I said, the response rate is 40.6% versus 10% in sorafenib; and the PFS [progression-free survival], 7.4 months versus 3.7 months. So antitumor activity is very good.

And regarding adverse events, the hand-foot skin reaction is less as compared with sorafenib, and diarrhea is also less. And quality of life is better than with sorafenib. So it
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