- GSK
- 29 April 2024 17:21:19
Source: Sharecast
The FTSE 100 pharmaceuticals giant said the trial achieved its primary endpoint of overall survival (OS), showing a statistically significant improvement in survival rates across the entire patient population.
It said the OS benefit extended to both prespecified subgroups in the trial - mismatch repair deficient (dMMR), microsatellite instability-high (MSI-H), and mismatch repair proficient (MMRp), microsatellite stable (MSS) patient categories.
That, GSK said, was a significant milestone as it followed the trial meeting its other primary endpoint of progression-free survival (PFS) earlier, with a notable reduction in the risk of disease progression or death in both the dMMR/MSI-H population and the overall patient group.
Complete results from the latest analysis will be released through a medical journal and shared at an upcoming scientific meeting.
Regarding safety, GSK said the combination of dostarlimab, carboplatin, and paclitaxel mirrored the established safety profiles of each agent, with the most frequent treatment-related adverse events including nausea, alopecia, fatigue, and peripheral neuropathy.
Jemperli previously received regulatory approvals for a specific subset of endometrial cancer patients, grounded in positive results from the RUBY trial’s part one concerning progression-free survival.
In July, the United States FDA sanctioned its use in combination with carboplatin and paclitaxel for adults with primary advanced or recurrent dMMR endometrial cancer.
That was followed by approval in the UK in October for the same combination in treating dMMR/MSI-H endometrial cancer, with applications still under evaluation in the EU, Australia, Canada, Switzerland, and Singapore.
“With today’s headline results from part one of the phase three RUBY trial, dostarlimab plus chemotherapy has become the only immuno-therapy combination to show a survival benefit in this broader patient population in this treatment setting,” said GSK’s senior vice-president and global head of oncology research and development Hesham Abdullah.
“We look forward to sharing detailed results of this analysis with regulatory authorities and the larger scientific community.”
Reporting by Josh White for Sharecast.com.