GSK Receives Positive CHMP Opinion for Jemperli (Dostarlimab) Plus Chemotherapy in dMMR/MSI-H Advanced or Recurrent Endometrial Cancer

Biopharmaceutical CompanyGlaxoSmithKline PLC.(GSK.US) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) Adopted a positive opinion, recommending the approval of Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy).

Recommended for the treatment of adult patients with primary advanced or recurrent endometrial cancer characterized by mismatch repair deficiency (dMMR)/high microsatellite instability (MSI-H), who are candidates for systemic therapy.

The company expects the EU to make a decision on its marketing authorization by the end of this year.

If approved, dostarlimumab in combination with chemotherapy will become a new first-line treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer in the EU.

GlaxoSmithKline PLC.The dostarlimab authorization application is based on the interim analysis results of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III clinical trial.

The first part of the RUBY trial met its primary endpoint, which was acceptance in the dMMR/MSI-H population.dostarlimumabProgression-Free Survival (PFS) in patients treated with carboplatin and paclitaxel.

The company pointed out,dostarlimumabThe safety and tolerability of the combination of carboplatin and paclitaxel are generally consistent with the known safety profiles of the individual drugs.

This opinion was put forward following the expansion of Jemperli's label in the U.S. to include this indication in July 2023.

Jemperli was also approved earlier this month in the UK in combination with platinum-based chemotherapy for adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The application is still under review in Australia, Canada, Switzerland, and Singapore.

In the EU, Jemperli has been granted conditional approval as a monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer who have progressed during or after prior platinum-based therapy.

Once approved by the European CommissionJemperli+ First-line indications for chemotherapy, this conditional approval will simultaneously convert to full approval. A decision is expected to be made by the end of this year.

Jemperli was discovered by AnaptysBio and licensed to TESARO under a collaboration and exclusive license agreement. This collaboration has led to three monospecific antibody therapies entering clinical trials. According to the agreement,GlaxoSmithKline PLC.Will be responsible for the ongoing research, development, commercialization, and production of these drugs.

Editor: Guo Mingyu