[Image courtesy of GSK]
The addition of dostarlimab to chemotherapy has shown promising results, with a 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively, compared to placebo plus chemotherapy.
The phase 3 RUBY clinical trial demonstrated the safety and tolerability of dostarlimab combined with the chemotherapy drugs carboplatin and paclitaxel. This combination may enhance endometrial cancer treatment by generating synergistic effects. Although the first interim analysis showed a meaningful overall survival (OS) trend, statistical significance was not achieved. GSK plans further analysis.
In the RUBY trial, the placebo group received chemotherapy plus a placebo. The trial revealed a significant improvement in progression-free survival (PFS) for both the dMMR/microsatellite instability-high (MSI-H) population and the overall population. Severe and serious treatment-emergent adverse events (TEAEs) increased by 10% with dostarlimab plus carboplatin-paclitaxel compared to placebo. However, immune-related adverse events (irAEs) were consistent with dostarlimab’s mechanism of action and similar to those reported for other PD-(L)1 inhibitors. These results were presented at the SGO annual meeting’s virtual plenary. The New England Journal of Medicine also published the results.
Patients in the study had either primary advanced stage III or IV or first recurrent endometrial cancer. Dr. Mansoor Raza Mirza, the RUBY trial’s principal investigator, stated that the RUBY clinical trial results represent a significant breakthrough in endometrial cancer treatment after decades of stagnation. GSK seeks to make dostarlimab the cornerstone of their immuno-oncology research and development program, both as a standalone treatment and in combination with standard and novel cancer therapies.
GSK is also investigating dostarlimab in registrational-enabling studies for patients with primary advanced or recurrent endometrial cancer, stage III or IV non-mucinous epithelial ovarian cancer, and other advanced solid tumors or metastatic cancers. The RUBY trial’s positive outcomes emphasize the potential of dostarlimab and other pipeline therapies in transforming endometrial cancer treatment. Ongoing research and development of new treatment options are essential to address the challenges and unmet needs in this field.
In addition to the promising potential of dostarlimab, several other treatments are under development for endometrial cancer. Investigational therapies such as the lenvatinib-pembrolizumab combination, developed by Eisai (TYO:4523) and Merck (NYSE:MRK), and the PARP inhibitor niraparib, developed also from GSK, show potential in addressing unmet needs in endometrial cancer treatment. These therapies, combined with continued advancements in immunotherapy and targeted therapy, could lead to an evolving landscape of treatment options for patients.
Filed Under: clinical trials, Drug Discovery, Oncology
