FDA Grants Priority Review for Expanded Indication of GSK’s Jemperli

Global biopharma company, GSK, has announced, in an April 24, 2024 press release, that FDA has accepted its supplemental Biologics License Application (sBLA) for the use of dostarlimab (Jemperli) in combination with chemotherapy in all adult patients with primary advanced or recurrent endometrial cancer (1).

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that works by binding to the PD-1 receptor and blocking it from interacting with the PD-1 ligands, PD-L1 and PD-L2. FDA already approved the use of dostarlimab in combination with standard chemotherapy (carboplatin and paclitaxel), followed by dostarlimab alone to treat adults with primary advanced or recurrent endometrial cancer that has been determined as being mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) in July 2023 (2).

“[The] expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” said Hesham Abdullah, senior vice president, Global Head Oncology, R&D, GSK, in the press release (2). “Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit. These results and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

The RUBY clinical study is a two-part global, randomized, double-blind, multicenter Phase III trial evaluating dostarlimab in patients with primary advanced or recurrent endometrial cancer. FDA’s recent decision to accept the sBLA has been based on the results from the first part of the RUBY study, which evaluated dostarlimab plus chemotherapy, followed by dostarlimab versus chemotherapy plus placebo, followed by placebo.

Additionally, dostarlimab’s conditional approval in the European Union was converted to full approval as a monotherapy for second-line dMMR/MSI-H recurrent or advanced endometrial cancer in December 2023 (3). “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,” noted Abdullah, in the press release about the European approval. “We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy.”

References

1. GSK. US FDA Accepts for Priority Review GSK’s Application for an Expanded Indication of Jemperli (Dostarlimab) Plus Chemotherapy to Include All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer. Press Release, April 24, 2024.
2. GSK. Jemperli (Dostarlimab) Plus Chemotherapy Approved in the US as the First New Frontline Treatment Option in Decades for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer. Press Release. July 31, 2023.
3. GSK. GSK’s Jemperli (Dostarlimab) Plus Chemotherapy Approved as the First and Only Frontline Immuno-Oncology Treatment in the European Union for Dmmr/MSI-H Primary Advanced or Recurrent Endometrial Cancer. Press Release, Dec. 11, 2023.

Source: GSK