Post-Hoc Analysis of Phase 3 REFLECT Trial Reveals Depth of Response Correlates with Survival in Unresectable HCC Treated with Lenvatinib

Jul 02, 2024 07:31 CST Updated 07:31

Eisai

Pharmaceutical Product R&D and Manufacturer

▎WuXiEdited by Kant Content Team

Eisai recently announced the results of a post-hoc analysis from the Phase 3 REFLECT trial, which examined the depth of response characteristics of the small molecule therapy Lenvima (lenvatinib) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). The analysis showed,The median overall survival (OS) of patients treated with Lenvima who achieved near-complete response (near-CR) was similar to that of patients with complete response (CR).

In the REFLECT trial, 478 patients were randomly assigned to receive Lenvima treatment, and 194 (41%) patients achieved objective response and were included in this analysis. Among these 194 patients who achieved objective response, 10 had complete response (CR) and 184 had partial response (PR).49 patients achieved near complete response with Target Lesion Reduction (TLR) ≥75%, 72 patients achieved partial response (PR) with TLR ≥50% and <75%, and 63 patients achieved PR with TLR ≥30% and <50%.

Analysis shows,The OS of CR patients (25.4 months) and near-complete remission patients (23.4 months) was similar and higher than that of PR patients with TLR≥50% and <75% (19.8 months) and PR patients with TLR≥30% and <50% (14.4 months).

The median duration of response (DOR) for CR patients was 20.3 months. The median DOR for near-CR patients and PR patients with TLR≥50% and <75% was similar, at 7.7 months and 7.3 months, respectively. Among near-CR patients, 10.2% maintained a response lasting over 18 months, while 8.3% of PR patients with TLR≥50% and <75% maintained a response lasting over 18 months.

Lenvima is a tyrosine kinase inhibitor.Based on the data from the REFLECT trial, it was approved by the U.S. FDA in August 2018 for the treatment of patients with unresectable hepatocellular carcinoma. The press release stated that this isThe first analysis of this type of patient approaching near-complete remission showed that Lenvima might help these patients achieve survival times comparable to those who achieved complete remission.

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References:

[1] New Post-Hoc Analysis from Phase 3 REFLECT Trial Presented at ESMO GI 2024 Explores Efficacy Outcomes with LENVIMA® (lenvatinib) Based on Depth of Tumor Response in Unresectable Hepatocellular Carcinoma. Retrieved June 30, 2024, from https://www.prnewswire.com/news-releases/new-post-hoc-analysis-from-phase-3-reflect-trial-presented-at-esmo-gi-2024-explores-efficacy-outcomes-with-lenvima-lenvatinib-based-on-depth-of-tumor-response-in-unresectable-hepatocellular-carcinoma-302184539.html

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