Recently, the United States announced that it has accelerated the approval of the anti-PD-1 antibody Jemperli (Dostarlimab) developed by GlaxoSmithKline (GSK) to treat patients with relapsed or advanced endometrial cancer.
These patients progressed after receiving platinum-containing chemotherapy and carried abnormal characteristics of DNA repair called mismatch repair defects (dMMR).
Dostarlimab is a PD-1 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-1 ligand and PD-L2.
This species has been granted a breakthrough therapy by the FDA for the treatment of endometrial cancer, and has priority approval.
Dostarlimab was discovered by AnaptysBio and was exclusively licensed to TESARO in March 2014.
TESARO was acquired by GSK in 2019.
The International Antibody Society (The Antibody Society) publishes a report every year, which summarizes and analyzes the development of new drugs in the antibody field.
According to a report released by the agency in 2021, there are 16 antibody drugs worthy of attention, including GSK's Dostarlimab.
The key study approved by Dostarlimab is a single-arm, multi-cohort clinical trial (GARNET study).
The GARNET study currently represents the largest data set of anti-PD-1 monotherapy for women with endometrial cancer.
Among 71 patients with relapsed or advanced endometrial cancer who received Dostarlimab treatment, Dostarlimab achieved a total remission rate of 42.
3%, and for 93% of remission patients, the duration of remission was more than 6 months.
Endometrial cancer is a common type of cancer in women around the world.
About 75% of endometrial cancers are diagnosed at an early stage and can usually be cured by surgery.
However, women with advanced and recurrent endometrial cancer have limited treatment options after using platinum-containing chemotherapy for first-line standard treatment.
Endometrial cancer can be divided into two types: microsatellite stable (MSS, 75% of the total) and high microsatellite instability (MSI-H, 25% of the total).
For patients with cancer recurrence, there is currently only one approved therapy for the subgroup of patients with MSI-H tumors, and there is no approved therapy for the subgroup of patients with MSS tumors.
Therefore, these relapsed patients still have great unfinished medical needs.
When it comes to immunotherapy, many people know PD-1 and PD-L1 monoclonal antibodies.
In 2019, the global PD-1/PD-L1 monoclonal antibody drug market has exceeded US$20 billion.
According to Research and Markets' forecast, with the continuous approval of indications and the continuous acceleration of new drug listings, the global sales of PD-1/PD-L1 will maintain a compound annual growth rate of 23.
4% in the future, and it is expected to reach US$50 billion by 2025.
The four major indications of lung cancer, liver cancer, gastric cancer and esophageal cancer are the battleground of military experts.
GSK won the endometrial cancer, differentiated competition, and occupied the market first, looking forward to subsequent performance.