Eisai and Merck announced results from presentations of new data and analyses of LENVIMA, an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in four different tumor types: unresectable hepatocellular carcinoma, squamous cell carcinoma of the head and neck, advanced renal cell carcinoma, and advanced endometrial carcinoma. LENVIMA and KEYTRUDA are not approved for use in combination in any cancer types today. Early phase results from Study 116/KEYNOTE-524 support further investigation in unresectable HCC. Study 116/KEYNOTE-524 is a Phase 1b open-label, single-arm multicenter study evaluating the tolerability and safety of the combination of LENVIMA and KEYTRUDA in patients with unresectable HCC, Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, and ECOG performance status of 0 or 1. The primary endpoint was safety; secondary and exploratory endpoints included overall survival, objective response rate, progression-free survival and time to progression using modified Response Evaluation Criteria in Solid Tumors criteria. Tumor assessments of complete or partial response were confirmed greater than or equal to four weeks after initial response. Part 1 evaluated tolerability by assessing dose-limiting toxicities during the first cycle of treatment in patients for whom no other appropriate therapy was available. After tolerability was confirmed, additional patients with no prior systemic therapy for unresectable HCC were enrolled. The expansion part of the study will evaluate ORR and duration of response as measured by mRECIST.
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