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OrganizeSlowly
On September 27th, Merck & Co.
(MSD) announced that, among Asian patients with advanced hepatocellular carcinoma (HCC) who have previously received sorafenib (sorafenib) treatment, a phase 3 clinical trial of the blockbuster PD-1 antibody therapy Keytruda The trial reached the primary endpoint of overall survival (OS)
.
Compared with placebo plus best supportive care (BSC), Keytruda+BSC resulted in a statistically significant improvement in the overall survival (OS) of patients
In this clinical trial called KEYNOTE-394, Merck conducted Keytruda testing on 453 Asian patients
.
In addition to reaching the primary endpoint of overall survival, the trial also reached the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR)
The success of this research is undoubtedly good news for Merck
.
Keytruda was granted accelerated approval by the U.
S.
FDA in November 2018 for the treatment of hepatocellular carcinoma patients previously treated with sorafenib
.
However, in a previous trial of KEYNOTE-240, which measured survival rates, Merck’s Keytruda used sorafenib to treat hepatocellular carcinoma after undergoing unclear confirmation trials on two survival indicators.
The primary endpoints of OS and PFS were not reached
.
The failure to show the survival benefit of the treatment prompted regulatory agencies to consider withdrawing Merck’s Keytruda accelerated approval based on tumor response data
This is because early this year, the FDA Oncology Center of Excellence launched an industry-wide review to review accelerated approvals that have not yet shown clinical benefit in confirmatory trials
.
This action involves several indications for the PD-1/L1 inhibitors of Merck, Bristol-Myers Squibb, Roche and AstraZeneca in the United States, including small cell lung cancer, gastric cancer, bladder cancer, liver cancer and triple negative breast cancer
Therefore, in late April of this year, the FDA Oncology Drug Advisory Committee organized a three-day meeting to specifically discuss 6 adaptations that some PD-1/PD-L1 drugs were marketed in the form of "accelerated approval" but failed in confirmatory clinical trials In order to decide whether to keep it on the market, the indications for Keytruda's second-line treatment of hepatocellular carcinoma are covered
.
However, although the drug missed the dual primary endpoint of the early study, it was recognized by oncologists.
In the end, ODAC unanimously decided to keep Keytruda on the market as a second-line treatment for hepatocellular carcinoma by 8 to 0
.
With the success of the research, the faltering state of Merck’s K-medicine hepatocellular carcinoma accelerated approval indication is somewhat stabilized
.
In fact, the FDA has been under pressure to expedite the approval of drug status based on early data review, because in some cases, confirmatory trials have not been completed, or these studies have failed to prove patient benefits
.
This problem is particularly troublesome in cancer and rare disease research, because a large number of new therapies and severely ill patients bias the FDA's usual calculations towards early approval
The FDA review road will continue
.
On September 24, the FDA stated that it would hold an oncology drug expert advisory committee meeting on December 2 to review whether the other two drugs should maintain their conditional accelerated approval status
Reference source:
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