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Article source: Medical Rubik's Cube Info
Author: Shi Bei
On August 23, Merck announced that based on the review opinions of the Independent Data Monitoring Committee (IDMC), the company decided to terminate the Phase II INTR@PID BTC 055 study because it is unlikely to reach the primary end point of overall survival (OS)
.
This study aims to evaluate the efficacy and safety of Merck's TGF-β/PD-L1 bifunctional fusion protein bintrafusp alfa combined with gemcitabine and cisplatin in the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC)
It is understood that this is the fourth phase II/III clinical study that bintrafusp alfa failed this year
.
On January 15, the phase II (NCT03436563) study of patients with high microsatellite instability (MSI-H)/mismatch repair defect (dMMR) solid tumors after the treatment of bintrafusp alfa received immune checkpoint inhibitors (ICB).
On January 20, the phase III INTR@PID Lung 037 study of bintrafusp alfa vs.
pembrolizumab for the first-line treatment of PD-L1 high-expressing stage IV non-small cell lung cancer (NSCLC), because it is unlikely to reach the common primary endpoint and also advanced Terminate
.
On March 16, the second-line treatment of locally advanced or metastatic biliary tract cancer (BTC) with bintrafusp alfa, the second-line phase II INTR@PID BTC 047, was also terminated because it did not meet the primary endpoint
.
This study included 159 patients.
Bintrafusp alfa (M7824) was discovered by Merck.
It is a potential first-in-class bifunctional fusion protein that can simultaneously block the two immunosuppressive pathways of TGF-β and PD-L1 in the tumor microenvironment and relieve the immune system.
Inhibition state, improve the immune system's killing effect on cancer cells
.
bintrafusp alfa structure
In February 2019, Merck and GSK reached a global strategic cooperation alliance to jointly develop M7824
.
The two parties are jointly responsible for the future clinical development and commercial promotion of M7824 on a global scale, and the resulting costs and profits will also be shared equally by both parties
The same target drug Hengrui SHR-1701 is in the phase III clinical phase, the PM8001 of Maiwei Biological is in the phase I/II research phase, and the CSPC Y101 has been declared for clinical use
