Lenvatinib Shows Noninferior Survival Outcomes and Improved PFS in HCC

EP: 1.Part 1: Using Scans and Biopsy to Diagnose HCC

EP: 2.Part 2: Factors for Considering Transplant or Immunotherapy in HCC

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EP: 3.Lenvatinib Shows Noninferior Survival Outcomes and Improved PFS in HCC

EP: 4.Part 1: Selecting Systemic Therapy in HCC With Serious Comorbidities

EP: 5.Part 2: Managing Frontline Lenvatinib Therapy for High-Risk HCC

EP: 6.Considering Treatment for Patients with HCC and Autoimmune Disease

EP: 7.Interpreting Results From New and Previous Trials of Lenvatinib in HCC

EP: 8.Discussing the LEAP-002 Trial of Lenvatinib Plus Pembrolizumab in HCC

EP: 9.Significance of Lenvatinib/Pembrolizumab Vs Lenvatinib Outcomes in HCC

EP: 10.Physicians Discuss Their Impressions of Recent IO/TKI Trials for HCC

EP: 11.Determining Need for Biopsy in Suspected Hepatocellular Carcinoma

EP: 12.Key Factors for Choosing Frontline Hepatocellular Carcinoma Therapy

Daneng Li, MD, Hepatobiliary Tumor Lead at the City of Hope, discusses the results of the REFLECT trial (NCT01761266) of lenvatinib (Lenvima) in hepatocellular carcinoma (HCC).

The phase 3 REFLECT trial randomized patients 1:1 to receive lenvatinib or sorafenib (Nexavar). The primary end point was noninferiority for overall survival (OS), while secondary end points included progression-free survival (PFS) and objective response rate (ORR).

According to Li, the REFLECT trial was the first randomized phase 3 trial with positive results in first-line treatment of HCC since the SHARP trial (NCT00105443) of sorafenib in 2007. The outcome demonstrated noninferiority of lenvatinib with a median OS of 13.6 months (95% CI, 12.1-14.9) versus 12.3 months (95% CI, 10.4-13.9; HR 0.92, 0.79-1.06) with sorafenib, leading to its approval by the FDA.

In addition to noninferior OS, Li says there was a more significant improvement in PFS of 7.4 months with lenvatinib versus 3.7 months with sorafenib. Furthermore, the results suggested that lenvatinib was more potent in terms of tumor shrinkage, with an ORR of 24% versus 9%.

TRANSCRIPTION:

0:08 | The REFLECT trial was really the first trial that we really had a positive finding versus sorafenib, and we had actually gone for, I would say, close to 10 years with several large negative phase 3 trials versus sorafenib. But the REFLECT trial was a noninferiority trial, meaning that it was meant to really define whether or not lenvatinib was noninferior to sorafenib, in terms of the primary end point of OS and REFLECT certainly met that primary end point. The median OS for patients that were treated with lenvatinib in the REFLECT trial was 13.6 months. And for those that were treated with sorafenib was 12.3 months. So really showing that lenvatinib was noninferior to sorafenib in terms of OS.

0:58 | In terms of secondary end points, interestingly, in terms of progression-free survival, there was definitely a significant improvement with patients that were treated with lenvatinib. Compared to sorafenib, the median PFS was 3.7 months for those patients that were treated with sorafenib and increased and improved to 7.4 months for those patients that were treated with lenvatinib.

In addition to that, in terms of the other secondary end points: in terms of ORR, lenvatinib was much more potent in terms of shrinking the tumors, the objective response for those patients that were treated with sorafenib was 9%, compared [with] 24% for those patients that were treated with lenvatinib, really showing that lenvatinib was able to achieve significant shrinkage in patients that were treated with this tyrosine kinase inhibitor.