FDA Accelerates Approval of GSK PD-1 Antibody To Treat dMMR Solid Tumors
Date of publication：2021/8/18 17:36:02
On August 17, GlaxoSmithKline plc (GSK) announced that the U.S. Food and Drug Administration (FDA) has accelerated the approval of its PD-1 antibody Jemperli (dostarlimab-gxly) for extended indications for the treatment of patients with relapsed or advanced solid tumors with mismatch repair-deficient (dMMR). The dMMR characteristics of these patients were confirmed by FDA-approved tests, the disease continued to progress after receiving the prior treatment, and there were no other satisfactory alternative treatment options. This is Jemperli's second indication approved by the FDA this year.
Mismatch repair-deficient tumor cells affect the normal repair of DNA damage during DNA replication. It is a biomarker that predicts the response to immune checkpoint inhibitors. Tumors carrying this biomarker mostly occur in endometrial cancer, colorectal cancer and gastrointestinal cancer, but may also occur in other solid tumors.
This approval is based on the results of a clinical trial called GARNET. The results showed that among all patients with dMMR solid tumors, Jemperli's objective response rate was 41.6% (95% CI; 34.9-48.6), and the complete response rate was 9.1%. The median duration of response was 34.7 months, and 95.4% of patients had a response lasting more than 6 months.
Among the 267 patients with relapsed or advanced dMMR solid tumors that can be assessed for safety, the most commonly reported adverse reactions (≥20%) are fatigue/weakness (42%), anemia (30%), diarrhea (25%) and nausea (22%). The most common grade 3 or 4 adverse reactions (≥2%) are anemia, fatigue/weakness, elevated transaminases, sepsis, and acute kidney injury. Grade 3 or 4 laboratory value abnormalities (≥2%) include lymphopenia, reduced sodium, increased alkaline phosphatase, and decreased albumin levels.
Dr. Hal Barron, Chief Scientific Officer and President of Research and Development of GSK, said: “Patients whose tumors carry dMMR biomarkers continue to require new and effective treatments. I am excited about GSK’s second FDA oncology approval this year, which provides patients with a New treatment options.”
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GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.