GSK's Jemperli (Dostarlimab) Plus Chemotherapy Receives Approval in Singapore

GSK's Jemperli (Dostarlimab) Plus Chemotherapy Receives Approval in Singapore

By, Admin 9 August 2024

GSK's Jemperli (dostarlimab) Plus Chemotherapy Receives Approval in Singapore for Advanced Endometrial Cancer

Overview

GSK Singapore has announced that the Singapore Health Sciences Authority (HSA) has approved a new indication for Jemperli (dostarlimab).

About Jemperli

  • Jemperli is a PD-1-blocking antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2. 
  • In Singapore, Jemperli is now approved in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR/MSI-H, and as a monotherapy for patients with dMMR recurrent or advanced endometrial cancer following a prior platinum-containing regimen.

Post Approval

This approval allows Jemperli to be used in combination with carboplatin and paclitaxel, followed by Jemperli as a monotherapy, for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

Jemperli: Indication

  • With this new approval, Jemperli is now indicated earlier in the treatment process, in combination with chemotherapy, for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. 
  • Previously, Jemperli was approved as a monotherapy for adult patients with dMMR recurrent or advanced endometrial cancer that had progressed following a prior platinum-containing regimen and were not candidates for curative surgery or radiation.

Endometrial Cancer in Singapore

  • According to the latest data from the Singapore Cancer Registry (2017-2021), endometrial cancer is the fourth most common cancer among females in Singapore and has the ninth highest cancer mortality rate, with 3,133 new cases diagnosed during this period. 
  • Approximately 15-20% of endometrial cancer patients globally, and 28% in Singapore, were at an advanced stage at the time of diagnosis. 
  • Globally, an estimated 20-29% of all endometrial cancers are dMMR/MSI-H. 
  • Until now, chemotherapy alone has been the standard treatment for primary advanced or recurrent endometrial cancer, with many patients experiencing disease progression.

RUBY trial: Outcomes

  • The RUBY trial demonstrated a 72% reduction in the risk of disease progression or death with Jemperli plus chemotherapy compared to chemotherapy alone. 
  • This significant result underscores Jemperli's potential to transform cancer treatment as a foundational immuno-oncology therapy.""

Metastatic Endometrial Cancer

  • Metastatic endometrial cancer is an aggressive disease with poor outcomes and limited effective treatment options. 
  • The RUBY trial results mark a clinical breakthrough for dMMR/MSH-I endometrial cancer. 
  • This new treatment combination offers many patients the chance for potential complete remission when administered early in their treatment.

Phase III Trial Analysis Submission by GSK 

  • GSK's submission to the HSA included interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial, which had a median follow-up duration of ≥ 25 months. 
  • The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), showing a statistically significant and clinically meaningful benefit for patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population. 
  • The data indicated a 72% reduction in the risk of disease progression or death.

Safety Profile

  • The safety profile of Jemperli combined with carboplatin and paclitaxel was consistent with known safety profiles of the individual agents. 
  • The most common treatment-emergent adverse events (≥ 20%) included rash, diarrhoea, hypothyroidism, and hypertension.

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