Express first-line treatment of advanced liver cancer, ALK-1 monoclonal antibody/Opdivo combination is clinically approved in China

▎The editor of WuXi AppTec's content team, Pioneer Pharmaceutical Co.
, Ltd.
, announced that China National Medical Products Administration (NMPA) has recently approved its ALK-1 monoclonal antibody (GT90001C), and Bristol-Myers Squibb (BMS) anti-PD-1 monoclonal antibody A clinical trial of nivolumab (English trade name Opdivo) in combination for the treatment of patients with advanced hepatocellular carcinoma (HCC) without systemic treatment
.

Liver cancer is the fourth most common cancer in China and the second most fatal cancer.
Advanced hepatocellular carcinoma accounts for 75-85% of liver cancers
.

ALK-1 monoclonal antibody is a fully humanized monoclonal antibody
.

As a potential "first-in-class" angiogenesis inhibitor, it can block the ALK-1 receptor pathway, inhibit ALK-1/TGF-β signal transduction and tumor blood vessel growth/generation, thereby slowing tumor growth.
It can also change the tumor microenvironment
.

Pioneer Pharmaceuticals obtained the exclusive global development, production and commercialization rights of the drug from Pfizer in 2018
.

In February of this year, the Phase 2 clinical trial of ALK-1 monoclonal antibody/nivolumab for the treatment of advanced hepatocellular carcinoma was approved by the US FDA
.

The Phase 2 clinical trial of ALK-1 monoclonal antibody/nivolumab combination therapy for the second-line treatment of patients with advanced hepatocellular carcinoma was first launched in 2019
.

Previously announced Phase 2 clinical trial data showed that the combination therapy has an encouraging effect and good safety, with an objective response rate (ORR) of 40%
.

Image source: 123RF "ALK-1 monoclonal antibody is a macromolecular drug introduced by Pioneer Pharmaceuticals from Pfizer.
Previously, in combination with Opdivo, the second-line treatment of advanced hepatocellular carcinoma after sorafenib failed has achieved very good results
.

"Dr.
Tong Youzhi, founder, chairman and CEO of Pioneer Pharmaceuticals, said, "At the same time, we are also working with Corning Jerry to explore the use of ALK-1 monoclonal antibody combined with KN046 double antibody to treat a variety of other entities in clinical trials.
Tumor
.

"Reference: [1] Kintor Pharma Announces China NMPA Approves Clinical Trial of ALK-1 and Nivolumab Combination Therapy for the First-line Treatment of Advanced Hepatocellular Carcinoma.
Retrieved October 11, 2021, from https:// .
com/news-releases/kintor-pharma-announces-china-nmpa-approves-clinical-trial-of-alk-1-and-nivolumab-combination-therapy-for-the-first-line-treatment-of-advanced -hepatocellular-carcinoma-301396741.
html[2] The first-line clinical trial of pioneering pharmaceuticals ALK-1 monoclonal antibody combined with O drug for the treatment of advanced hepatocellular carcinoma was approved by the China Food and Drug Administration.
Retrieved October 11, 2021, from https://www .
kintor.
com.
cn/news/231.
html Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.

This article is not a treatment recommendation either
.

If you need guidance on the treatment plan, please go to a regular hospital for treatment
.