Merck Announces KEYTRUDA® (pembrolizumab) Significantly Prolongs Overall Survival in Asian Patients with Advanced Hepatocellular Carcinoma in Phase 3 KEYNOTE-394 Trial
Oct 13, 2021 02:56
CST Updated
02:56
MSD
Pharmaceutical R&D and Manufacturer
October 13, 2021 /BioonBIOON/ --Merck & Co. recently announced the evaluation of the anti-PD-1 therapy Keytruda (pembrolizumab)Treatment of Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with the multikinase inhibitor sorafenibThe phase 3 KEYNOTE-394 trial (NCT03062358) met the primary endpoint of overall survival (OS).
KEYNOTE-394 is a randomized, double-blind, phase 3Clinical Trial(ClinicalTrials.gov, NCT03062358), conducted in Asian patients with advanced HCC who previously received sorafenib or oxaliplatin chemotherapy, is evaluating the efficacy and safety of Keytruda plus best supportive care (BSC) versus placebo plus BSC. The primary endpoint is OS, and secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).
A total of 453 patients were enrolled in this trial and randomized to receive Keytruda (administered via intravenous infusion once every 3 weeks for up to 35 cycles [up to 2 years]) in combination with BSC (including pain management and management of other potential complications, including the management of ascites according to local standards of care), or placebo in combination with BSC.
Results showed that,The trial met its primary endpoint: compared with placebo + BSC, Keytruda + BSC treatment significantly improved OS.In addition,The trial also met the key secondary endpoints of PFS and ORR: compared with placebo + BSC, Keytruda + BSC demonstrated statistically significant improvements in these endpoints.. During the trial, no new safety signals were observed. The results of the trial will be presented at the upcoming medicalMeetingpublished on.
Dr. Scot Ebbinghaus, Vice President of Clinical Research at MSD Research Laboratories, said: “Hepatocellular carcinoma (HCC) is often at an advanced stage# Diagnosis, is one of the solid tumors with the highest mortality rates. Despite recent advances, the need for anti-PD-1 monotherapy following sorafenib treatment remains unmet, while Keytruda represents an established treatment option for patients. In this study, Keytruda significantly improved overall survival, which is highly encouraging, and we look forward to engaging with regulatory authorities as soon as possible."
Based on the ORR and duration of response data from the KEYNOTE-224 trial, Keytruda received accelerated approval in November 2018 for the treatment of patients with HCC previously treated with sorafenib. A subsequent study, KEYNOTE-240, did not meet its dual primary endpoints of OS and PFS. On April 29, 2021FDATumorThe accelerated approval of Keytruda was discussed at the Oncologic Drugs Advisory Committee (ODAC) meeting, which voted 8 to 0 in favor of maintaining the accelerated approval for this indication. KEYNOTE-394 was discussed at the ODAC meeting as a potential confirmatory trial to verify the clinical benefit of Keytruda for these patients.
MSD is committed to advancing HCC research and has a global development program comprising seven clinical trials, whichClinical TrialApproximately 3,000 patients have been or are expected to be enrolled. In HCC, multiple Keytruda regimens and lines of therapy, both as monotherapy and in combination with other therapies (including those through our collaborations), are under investigation.