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FDA accelerates approval of GSK’s new endometrial cancer drug: Jemperli

FDA accelerates approval of GSK’s new endometrial cancer drug: Jemperli. The first in the world!

On April 23, the FDA accelerated the approval of the anti-PD-1 antibody Jemperli (dostarlimab) developed by GlaxoSmithKline (GSK) to be marketed as a single agent for the treatment of patients with mismatch repair defects (dMMR) with recurrent or advanced endometrial cancer. Become the first approved for the treatment of children…

It is reported that this approval is based on the results of a single-arm, multi-cohort clinical trial. The data shows that among 71 patients with dMMR recurrent or advanced endometrial cancer who received Jemperli treatment, the overall response rate ORR was 42.3%, of which The complete remission rate CR was 12.7%, and the partial remission rate PR was 29.6%. In addition, 93% of patients in remission can last for more than 6 months.

In 2020, 420,000 new endometrial cancers occurred, ranking sixth among common tumors in women, and are common gynecological malignancies. Approximately 75% of endometrial cancers can be cured by surgery after early diagnosis. However, patients with advanced and recurrent endometrial cancer have limited treatment options after first-line standard platinum-containing chemotherapy regimens, and approximately 25% to 30% of patients with advanced endometrial cancer have dMMR.

Jemperli is a humanized anti-PD-1 monoclonal antibody that can bind to the PD-1 receptor and block its interaction with the ligands PD-L1 and PD-L2. Jemperli exerts anti-cancer effects by targeting PD-1/PD-L1 cellular pathways. The drug was acquired by GlaxoSmithKline’s acquisition of Tesaro.

It is worth mentioning that Jemperli has also been granted breakthrough drug status and priority review status by the FDA. In addition, the European Medicines Agency (EMA) also stated that it will approve Jemperli in the near future for recurrent or late mismatch repair defects (dMMR)/microsatellite instability-high (MSI-H) adults with endometrial cancer Treatment of patients.

“Today’s approval of Jemperli reflects the FDA’s progress in applying precision drugs to expand the treatment options for cancer patients.” said Richard Pazdur, MD, director of the FDA Center for Oncology Excellence and Acting Director of the Office of Oncology and Diseases of the FDA Center for Drug Evaluation and Research.

In addition to the approval of new drugs, recent clinical research on the combination of endometrial cancer has also made significant progress.

In March of this year, Merck and Eisai announced for the first time their Keytruda and Lenvima combination treatment of advanced, metastatic or recurrent uterus after platinum-containing chemotherapy at the 52nd American Society of Gynecological Oncology (SGO) Women’s Cancer Annual Meeting in 2021. The key phase 3 NCT03517449 study data for patients with endometrial cancer. The results show that, compared with chemotherapy, the combination of Keytruda and Lenvima has an effect on the overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) of patients. There is a significant improvement.

Next, Merck and Eisai will submit applications for the combination therapy of Keytruda and Lenvima to various regulatory agencies based on these data. Previously, the FDA also granted the combination therapy three breakthrough drug qualifications, including the treatment of advanced and/or metastatic microsatellite stability (MSS)/mismatch repair normal (pMMR) endometrial cancer; treatment of advanced and/or metastatic endometrial cancer Renal cell carcinoma and advanced unresectable hepatocellular carcinoma for which first-line treatment is not suitable for localized treatment.

We look forward to the successful launch of more new therapies to provide precise treatment for patients with endometrial cancer.

(source:internet, reference only)

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