FDA approves Jemperli to treat dMMR-related endometrial cancer

FDA has approved Jemperli from GSK (NYSE:GSK) for adult patients with mismatch repair-deficient or advanced endometrial carcinoma (dMMR).

GSK predicts Jemperli will generate peak sales of $1.4 billion to $2.8 million.

The drug is indicated for adults with dMMR-related or advanced endometrial carcinoma who have progressed after a previous platinum-containing regimen. This drug is not suitable for those who need curative surgery or radiation.

Approved based on a Phase 1 study

The FDA approved the drug based on data from GARNET Phase 1, in which it had a 45.4% overall response rate. The single-arm, multicenter, open-label study of Jemperli monotherapy showed that 85.9% of patients experienced a response within 12 months. 54.7% had a response lasting at least 24 months.

Data from the ongoing GARNET trial’s A1 cohort supported Jemperli’s approval. This trial evaluated Jemperli as a monotherapy in patients with advanced solid tumors. The dru…

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GSK’s Jemperli fares well in interim analysis of endometrial cancer trial

GSK (LSE/NYSE:GSK) has shared positive headline results from a planned interim analysis of Part 1 of a Phase 3 study of adults with primary advanced or recurrent endometrial cancer. In the study, patients in the Jemperli (dostarlimab) arm also received chemotherapy (carboplatin-paclitaxel) followed by Jemperli alone.

The study tested the treatment regimen against chemotherapy with a placebo followed by a placebo in adult patients with primary advanced or recurrent endometrial cancer.

The RUBY study met its primary endpoint of investigator-assessed progression-free survival (PFS).

The overall population receiving Jemperli plus chemotherapy had statistically significant and clinically meaningful benefit. The same holds for patients with prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H).

While GSK acknowledges that the overall survival data remain inconclusive presently, the study found increased overall survival d…

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Dostarlimab drug trials: The science behind cancer and the therapy’s future

[Image courtesy of GSK]

Cancer treatment has been a critical point for clinical diagnostics. Over the years, various treatment approaches- from naked nucleic acid-based therapy, targeting microRNAs, oncolytic virotherapy, and suicide-gene-based therapy to CRISPR/Cas-9-based therapy. More recently, drug-based therapy has also emerged as a promising area for cancer therapeutics. Regarding drug administration, a major buzz has been created around dostarlimab, whose trials have yielded substantial results. Before this discovery, a series of gene therapeutics were initiated, with varying degrees of success.

Dostarlimab was first developed by AnaptysBio and later licensed to GSK (NYSE:GSK). The trade name for dostarlimab is Jemperli.

FDA approved dostarlimab for women with recurrent or advanced dMMR endometrial cancer in April 2021. In August of the same year, GSK won FDA accelerated approval for dostarlimab fo…

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