GSK immuno-oncology treatment achieves novel EU approval

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The European Commission (EC) has approved the first frontline immuno-oncology treatment in the EU for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) plus carboplatin-paclitaxel chemotherapy is indicated for these patients who are suitable for systemic therapy.

Additionally, the EC has converted its conditional approval of the biologic treatment Jemperli for adults with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regime, to a full approval, GSK confirmed.

An immuno-oncology treatment for endometrial cancer

Jemperli (dostarlimab) is programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2, as highlighted by research subsequently published in the European Journal of Cancer in 2016.

New immuno-oncology treatment approved for endometrial cancer

What data is the EC’s approval of Jemperli (dostarlimab) plus chemotherapy based on?

The EC’s authorisation of Jemperli is based on interim analysis results from the dMMR/MSI-H population of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial.

According to GSK, the trial demonstrated a 72 percent reduction in the risk of disease progression or death relative to chemotherapy alone in dMMR/MSI-H patients treated with Jemperli plus carboplatin and paclitaxel.

Prespecified, exploratory analysis of overall survival in dMMR/MSI-H participants found that adding Jemperli to chemotherapy enabled patients to experience a 70 percent reduction in the risk of death relative to chemotherapy alone.

The data was presented at the European Society for Medical Oncology (ESMO) and Society of Gynecologic Oncology (SGO) Annual Meeting in March 2023, and published in the New England Journal of Medicine.

“With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey… we believe that [Jemperli] continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy,” Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK noted.