British pharmaceutical firm GSK has received expanded approval from the European Commission (EC) for Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel).
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody, currently being developed by GSK in its ongoing immuno-oncology-based R&D programme.
The drug was discovered by US-based antibody development company AnaptysBio and licensed to TESARO in March 2014. In 2019, TESARO was acquired by GSK for $5.1bn.
Jemperli plus chemo was already approved in the EU to treat adults with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) advanced endometrial cancer (EC).
The current approval expands its indication to include adults with primary advanced or recurrent EC, who are candidates for systemic therapy, as the first-line treatment.
GSK oncology R&D global head and senior vice president Hesham Abdullah said: “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit.”
RUBY study principal investigator Mansoor Raza Mirza said: “Clinicians have been waiting for years for an immuno-oncology-based option that can meaningfully improve overall survival outcomes for patients with MMRp/MSS primary advanced or recurrent endometrial cancer.
“The expanded approval represents a significant advance that delivers on this hope, now for patients with both dMMR/MSI-H and MMRp/MSS tumours.”
The EC expanded approval is based on results from Part 1 of the RUBY, a two-part, multicentre Phase 3 clinical study of Jemperli plus chemotherapy in 785 patients.
RUBY Part 1 showed a clinically meaningful and statistically significant overall survival (OS) benefit for patients with primary advanced or recurrent EC.
In the study, Jemperli plus chemotherapy showed a 31% reduction in risk of death, compared to chemotherapy alone.
The Jemperli combination showed a safety profile that was generally consistent with the known safety profiles of the individual agents.
The most common adverse reactions include rash, rash maculopapular, hypothyroidism, pyrexia, increased alanine aminotransferase, aspartate aminotransferase and dry skin.
Furthermore, the British drugmaker said that Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show significant and clinically meaningful OS benefits.
