RUBY Trial Success: Broader Potential for Jemperli Combos in Advanced Endometrial Cancer

In a significant breakthrough for endometrial cancer treatment, a phase III clinical trial has demonstrated the efficacy of a combined immunotherapy and chemotherapy approach. The trial, known as RUBY, involved the use of Jemperli (dostarlimab-gxly) along with standard chemotherapy drugs. The study, which was conducted in two parts, focused on adult patients suffering from primary advanced or recurrent endometrial cancer.

Part 1 of the RUBY trial yielded substantial improvements in overall survival (OS) for patients treated with the combination of dostarlimab-gxly and chemotherapy, as opposed to chemotherapy with a placebo. Notably, the risk of death was reduced by 31%, and the median OS was extended by 16.4 months. In the prespecified MMRp/MSS population, a 21% reduction in the risk of death was observed, along with a seven-month increase in median OS.

Part 2 of the trial investigated the impact of adding Zejula (niraparib) to dostarlimab-gxly maintenance post chemotherapy. This addition resulted in a 37% reduction in the risk of disease progression or death and a six-month improvement in median progression-free survival (PFS) in the MMRp/MSS population. This is particularly significant given the limited treatment options available for this group of patients.

The findings were presented at the Society of Gynecologic Oncology's 2024 Annual Meeting, highlighting the potential for Jemperli-based treatment regimens to benefit a broader range of endometrial cancer patients. Hesham Abdullah, GSK's Senior Vice President of Global Oncology, R&D, emphasized the importance of these results, which support the role of dostarlimab-gxly in the immuno-oncology development program.

Matthew Powell, MD, a principal investigator of the RUBY trial, noted the significance of the trial's results, being the first to show a substantial improvement in OS for immuno-oncology therapy combined with chemotherapy in the overall population of patients with endometrial cancer.

The safety profile of the treatment组合 was consistent with the known profiles of the individual drugs, with immune-related adverse events being similar to those reported for other PD-(L)1 inhibitors. The US Food and Drug Administration is expected to review the trial data for a potential expanded indication for the treatment in the overall population.

Endometrial cancer, which affects the inner lining of the uterus, is the most common gynecologic cancer in developed countries, with a rising incidence rate. The RUBY trial's findings are a step forward in addressing the unmet needs of patients with advanced or recurrent disease, particularly those with MMRp/MSS tumors.

The RUBY trial's design included a broad patient population, reflecting real-world demographics and ensuring the results are applicable to a wide range of patients. The trial's success is a testament to the collaborative efforts of international research networks and underscores the importance of continued research in the field of immuno-oncology.

In summary, the RUBY trial's results offer hope for improved survival outcomes in endometrial cancer patients and highlight the potential of immunotherapy combined with traditional chemotherapy as a new standard of care. The data also reinforce the need for ongoing research to identify patient subgroups that can benefit the most from such treatments.