GSK's Jemperli Becomes First Anti-PD-1 Therapy Approved by FDA for Endometrial Cancer

April 23, 2021 News /BioValleyBIOON/ -- According to the United StatesFDAOfficial announcement: The agency granted accelerated approval on April 22.GlaxoSmithKline(GSK) The anti-PD-1 therapy Jemperli (dostarlimab, formerly TSR-042), as a monotherapy, is indicated for the treatment of patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer who have experienced disease progression during or after platinum-containing chemotherapy. Jemperli was approved under the accelerated approval pathway; previously, this drug had also beenFDAGranted Breakthrough Therapy Designation (BTD) and Priority Review status. dMMR is a condition that affects the normal repair of intracellular DNA

It is worth mentioning that,Jemperli is the first PD-1 therapy approved for the treatment of endometrial cancer.. Currently, Jemperli is also under review by the European Medicines Agency (EMA). In late February this year, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Jemperli. The European Commission (EC) is expected to approve Jemperli by the end of April.

Regarding medication administration, the first four doses of Jemperli are 500 mg every three weeks. Subsequent dosing (starting from the fifth dose), beginning three weeks after the fourth dose, is 1600 mg every six weeks. Jemperli is administered via intravenous infusion over a period greater than 30 minutes.

Director of the FDA Office of Oncology Excellence,FDACenter for Drug Evaluation and ResearchTumorRichard Pazdur, M.D., acting director of the Office of Oncologic Diseases, stated: “Today’s approval of Jemperli reflectsFDAAdvances in Applying Precision Medicine to Expand Treatment Options for Cancer Patients. This immunotherapy was specifically studied for dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanisms of immune response to address the unmet medical needs of this population.

Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in the United States, and its incidence is on the rise. Approximately 75% of endometrial cancers are diagnosed at an early stageDiagnosis, and can usually be cured with surgery. However, women with advanced and recurrent endometrial cancer have limited treatment options after receiving first-line standard therapy with platinum-based chemotherapy regimens. Approximately 25%-30% of patients with advanced endometrial cancer have dMMRTumor。

Jemperli is a humanized anti-PD-1 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2. The drug works by targeting the PD-1/PD-L1 cellular pathway (proteins present on human immune cells and some cancer cells). Jemperli helps the human immune system fight cancer cells by blocking this pathway.

Jemperli Clinical Efficacy Data

The regulatory approval of Jemperli for the treatment of dMMR endometrial cancer is based on data from the single-arm, multi-cohort GARNET study. These data represent the largest dataset for anti-PD-1 monotherapy in the treatment of endometrial cancer. The results showed that among 71 patients with recurrent or advanced dMMR endometrial cancer treated with Jemperli, there were42.3% of patients achieved complete response (CR, tumor disappearance) or partial response (PR,TumorShrinkage). In patients with disease remission,93% of patients had a duration of response ≥6 months.

In this study, common side effects of Jemperli included fatigue, nausea, and diarrhea,Anemiaand constipation. Jemperli can cause serious conditions known as immune-mediated adverse reactions, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis). (Bioon.com)

Original Source: United StatesFDANew Drug Database