European Commission Approves GSK’s JEMPERLI (dostarlimab), the First Anti-PD-1 Therapy for Recurrent or Advanced Endometrial Cancer
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
GlaxoSmithKline(GSK) recently announced that the European Commission (EC) has granted conditional marketing authorization to Jemperli (dostarlimab, formerly TSR-042), a PD-1 blocking antibody for the treatment of patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following platinum-containing chemotherapy.This approval makes Jemperli the first anti-PD-1 therapy approved for the treatment of endometrial cancer in Europe.
Recently, Jemperli also received accelerated approval from the US FDA as a monotherapy for the treatment of patients with dMMR recurrent or advanced endometrial cancer that has progressed during or following platinum-based chemotherapy. Jemperli was approved through the accelerated approval pathway and was previously also...FDAGranted Breakthrough Therapy Designation (BTD) and Priority Review designation.
GlaxoSmithKlineDr. Hal Barron, Chief Scientific Officer and President of Research and Development, said: “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 women in Europe will have access to an innovative, much-needed treatment for the first time.”
Endometrial cancer
Endometrial cancer is a malignancy originating in the endometrium. It is the most common type of cancer affecting the female reproductive organs and ranks as the sixth most common cancer among women worldwide. Approximately 75% of endometrial cancers are at an early stage.Diagnosis, which is typically curable with surgery. However, treatment options are limited for women with advanced and recurrent endometrial cancer following first-line standard platinum-based chemotherapy regimens.In allTumorAmong them, endometrial cancer has the highest frequency 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 (proteins present on human immune cells and certain cancer cells). Jemperli helps the human immune system fight cancer cells by blocking this pathway.
The European Commission approved 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,The objective response rate (ORR) with Jemperli treatment was 43.5% (95% CI: 34-53.4).、 Disease control rate (DCR) was 55.6% (95% CI: 45.7–65.1). Among patients with objective response, the median duration of response (DOR) was not reached (2.6 to 28.1+),The probability of maintaining remission at 6 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%), pyrexia (10.5%), and hypothyroidism (10.1%). Seventeen patients (3.3%) permanently discontinued treatment due to adverse events; most were immune-related events. The incidence of serious adverse events 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.
Source: European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer