A breakthrough therapy drug for the treatment of intestinal cancer

According to WHO, rectal cancer ranks eighth in the world in terms of prevalence. At the same time, the survival rate for this type of disease is no more than 50 %. GSK's development has received the status of a "breakthrough therapy" from the FDA after demonstrating 100% effectiveness in the treatment of colorectal cancer.

The drug Jemperli (dostarlimab) is a monoclonal antibody, an inhibitor of the PD-1 checkpoint, the "brakes" of the immune system. Tumors are often able to produce PD-L1 ligand proteins that binds to the PD-1 receptor and suppress immune T cells. This causes the immune system to stop fighting the tumor. PD-1 receptor inhibitors disable the "brakes" of the immune system and allow it to fully exhibit antitumor activity.

Dostarlimab has already been successfully registered in the USA and Europe and has been used for the treatment of endometrial cancer since April 2021.

GSK is currently conducting clinical trials of the drug to expand the indications for use. As part of the phase II CI, dostarlimab has shown 100% efficacy in the treatment of locally advanced colorectal cancer. All patients treated with Jemperli had complete tumor regression without the need for surgery, radiation therapy, or chemotherapy, which often lead to serious complications, including infertility and intestinal dysfunction.

24 subjects remained free of any signs of the disease for 26 months. The study is scheduled to be completed at the end of 2026.

The status of a "breakthrough therapy" will allow Jemperli to be registered much faster, and GSK will be able to receive comprehensive regulatory support in organizing clinical trials.