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October 3, 2017updated 13 Jul 2022 10:08am

Eisai reports positive Phase III trial data of Lenvima for liver cancer

Eisai has reported positive results from analysis of the subpopulation of subjects in the Greater China region participating in its Phase III REFLECT clinical trial of lenvatinib mesylate (Lenvima) to treat unresectable hepatocellular carcinoma (HCC). 

Eisai has reported positive results from analysis of the subpopulation of subjects in the Greater China region participating in its Phase III REFLECT clinical trial of lenvatinib mesylate (Lenvima) to treat unresectable hepatocellular carcinoma (HCC).

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Discovered and developed by the firm, lenvatinib is an oral inhibitor of multiple receptor tyrosine kinase (RTK) being developed to selectively inhibit the kinase activities of vascular endothelial growth factor (VEGF) receptors and fibroblast growth factor (FGF) receptors.

Based on an extension of overall survival (OS) in the subpopulation, lenvatinib was found to be effective when compared with sorafenib as a first-line treatment in the REFLECT trial.

The drug candidate further demonstrated improvements in progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).

REFLECT’s Greater China subpopulation included 288 patients out of the total 954 subjects participating in the trial.

“The drug candidate further demonstrated improvements in progression-free survival, time to progression and objective response rate.”

It was observed that for 80% of these patients whose HCC was due to chronic hepatitis B virus infection, their median OS using lenvatinib was 14.9 months compared with 9.9 months with sorafenib.

The results indicated that the safety profile for the subpopulation was consistent with that of its previous studies.

Lenvatinib is currently approved for the treatment of refractory thyroid cancer in more than 50 countries such as the US and Japan, in addition to Europe.

As a combination therapy with everolimus, the drug candidate is approved as a second-line treatment for renal cell carcinoma various countries.

The firm is also conducting a Phase Ib trial with lenvatinib for HCC, along with a Phase Ib/II trial with pembrolizumab combination for certain solid tumours.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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