Investigational data on the lenvatinib plus pembrolizumab combination that will be presented includes results from the Phase 2 LEAP-005 trial (NCT03797326) evaluating multiple cohorts of patients with previously treated solid tumors, including: gastric cancer (Abstract #230), biliary tract cancers (Abstract #321) and colorectal cancer (Abstract #94).
Additional data to be presented include findings from a post-hoc analysis in patients with unresectable hepatocellular carcinoma (HCC) who progressed to Child-Pugh B liver function in the Phase 3 REFLECT trial (NCT01761266) evaluating lenvatinib (Abstract #298). Also, real-world effectiveness of lenvatinib monotherapy among unresectable HCC patients in
'These studies demonstrate our commitment to explore the therapeutic potential of lenvatinib-both as a monotherapy and investigational combination therapy-and continue to build evidence in clinical practice post approval-across advanced gastrointestinal cancers,' said Dr.
In
This release discusses investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
The full list of
About LENVIMA (lenvatinib) Capsules
LENVIMA is indicated: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC)
In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial
LENVIMA, discovered and developed by
About the
In
In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, and triple-negative breast cancer) across 20 clinical trials.
About
Contact:
Tel: 551-579-4465
Email: michelerandazzo@eisai.com
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