European Commission Approves GSK’s Jemperli (Dostarlimab) as First Anti-PD-1 Therapy for Recurrent or Advanced Endometrial Cancer

April 28, 2021 News /BioValleyBIOON/ --GlaxoSmithKline(GSK) recently announced that the European Commission (EC) has granted conditional marketing authorization for Jemperli (dostarlimab, formerly TSR-042), a PD-1 blocking antibody, for the treatment of patients with recurrent or advanced endometrial cancer with mismatch repair deficiency (dMMR)/high microsatellite instability (MSI-H) who have progressed during or after platinum-based chemotherapy.This approval makes Jemperli the first anti-PD-1 therapy available in Europe for the treatment of endometrial cancer.

Recently, Jemperli also received accelerated approval from the U.S. FDA as a monotherapy for the treatment of patients with dMMR recurrent or advanced endometrial cancer who have experienced disease progression during or after platinum-based chemotherapy. Jemperli was approved through the accelerated approval pathway and had previously beenFDAGranted Breakthrough Therapy Designation (BTD) and Priority Review status.

GlaxoSmithKlineDr. Hal Barron, Chief Scientific Officer and President of Research and Development, stated: “Women with dMMR/MSI-H recurrent or advanced endometrial cancer whose disease progresses during or after chemotherapy currently have limited treatment options and a poor prognosis. Today’s approval of Jemperli means that female patients in Europe will have access to an innovative, much-needed therapy for the first time.”

Endometrial Cancer

Endometrial cancer is a malignancy arising from the endometrium. It is the most common cancer affecting the female reproductive organs and ranks as the sixth most common cancer among women worldwide. Approximately 75% of endometrial cancers are diagnosed at an early stage.Diagnosiscan usually be cured by surgery. However, women with advanced and recurrent endometrial cancer have limited treatment options after receiving first-line standard therapy with platinum-based chemotherapy regimens.In allTumorAmong these, endometrial cancer has the highest incidence of the MSI-H phenotype.

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 pathway, which involves proteins found on human immune cells and some cancer cells. Jemperli helps the body's immune system fight cancer cells by blocking this pathway.

The European Commission Approves Jemperli for the Treatment of dMMR/MSI-H Endometrial Cancer, 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. Cohort A1 of the study (n=108 efficacy-evaluable patients) enrolled women with recurrent or advanced dMMR/MSI-H endometrial cancer who experienced disease progression during or after platinum-based chemotherapy.

The results showed that,Jemperli demonstrated an objective response rate (ORR) of 43.5% (95% CI: 34–53.4)., the disease control rate (DCR) was 55.6% (95% CI: 45.7–65.1). Among patients who achieved a response, the median duration of response (DOR) had not been reached (range: 2.6 to 28.1+ months),The probability of maintaining remission at 6 months and 12 months was 97.9% (95% CI: 85.8–99.7) and 90.9% (95% CI: 73.7–97.1), respectively.

Among the 515 patients with advanced or recurrent solid tumors enrolled in the GARNET study, including 129 patients in Cohort A1, the most common adverse reactions (incidence ≥10%) wereAnemia(25.6%), nausea (25.0%), diarrhea (22.5%), vomiting (18.4%), arthralgia (13.8%), pruritus (11.5%), rash (11.1%), fever (10.5%), and hypothyroidism (10.1%). Seventeen patients (3.3%) permanently discontinued treatment due to adverse reactions; most were immune-related events. The incidence of serious adverse reactions was 8.7%; most were immune-related.Adverse Reactions. The safety profile of patients in the A1 cohort was comparable to that of the overall study population. (Bioon.com)

Original Source: European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapyapproved for recurrent or advanced endometrial cancer