- Endometrial cancer is the most common gynecologic cancer in the U.S.
- In 2024, the FDA approved a new standard of care for treating advanced or recurrent endometrial cancer, thanks in part to a clinical trial supported by Providence.
- The study found that immunotherapy combined with chemotherapy can improve outcomes for patients with advanced disease.
- This approach is now the standard of care for advanced or recurrent endometrial cancer.
Endometrial cancer is the most common gynecologic cancer in the United States, with over 66,000 new cases diagnosed each year. When caught early, it has relatively high survival rates, yet advanced stages of the disease are more difficult to treat.
Now, thanks in part to the work of gynecologic oncology researchers at Providence, healthcare providers and patients nationwide have a new standard of care for advanced or recurrent cases.
FDA approval of pembrolizumab
Until recently, chemotherapy alone was the first line of treatment for most patients with advanced or recurrent endometrial cancer. In June of 2024, the Food and Drug Administration (FDA) approved the immunotherapy medication pembrolizumab with the chemotherapy drugs carboplatin and paclitaxel, followed by single agent pembrolizumab, for adult patients with advanced cases of this disease. This approval represents a major shift, making immunotherapy part of the new standard of care in front-line treatment.
The FDA decision relied on data from two studies, including the NRG-GY018 clinical trial, which was supported by Providence. Our Seattle- and Anchorage-based teams at Providence Swedish, led by Fernanda B. Musa, M.D., and Joanie M Hope, M.D., enrolled many patients into the trial, placing them among the top enrolling sites in this nationwide, multi-site trial.
During the trial, 810 participants were treated with chemotherapy with and without pembrolizumab, a checkpoint inhibitor. The trial was designed to analyze outcomes in both MMR proficient and deficient tumors. MMR (mismatch repair) status gives cells the ability to repair errors in their DNA, hence, MMR deficient cancers are unable to repair their DNA via this specific mechanism. Patients with an inheritable condition called Lynch Syndrome, are often MMR deficient, for instance. MMR deficient cancers are more likely to respond to immunotherapy such as pembrolizumab, and this was observed in the trial.
What is more remarkable is that patients with MMR proficient cancers also benefited. A peer-reviewed manuscript about the study and its findings, co-authored by Drs. Musa and Hope, was published in 2023 in the New England Journal of Medicine. The trial was available through the NCI NCORP program, which aims to make clinical trials accessible to a broader community.
As Dr. Musa explains, research is a team-based sport that unites healthcare professionals, researchers and patients across our network and beyond. “While there are many people who make this type of research possible, I want to give a special thank you to our patient volunteers. I would like to acknowledge our SCI Gyn Oncology team under the leadership of Evonne Lackey, Samantha Megrath and Chun-Fang Qiu, our study coordinators, data managers, regulatory workers, research nurses and my partners, who are fully committed to advancing our field,” adds Dr. Musa. “This team-based effort has helped improve care for thousands of women diagnosed with endometrial cancer every year.”
Immunotherapy plus chemotherapy: A new standard of care
On August 1, 2024, the FDA expanded the use of another immunotherapy drug, dostarlimab-gxly, in combination with carboplatin and paclitaxel for patients with advanced or recurring endometrial cancer. This approval was based on the RUBY trial, which looked at the efficacy and safety of immunotherapy in combination with chemotherapy.
Together, these two clinical trials began the transformation of the standard of care for patients with advanced or recurrent endometrial cancer, establishing a new approach that combines chemotherapy and immunotherapy. Additional research is still needed to further refine the patient groups that benefit the most from this strategy.
Providence looks forward to contributing to this ongoing work through continued participation in the National Cancer Institute’s Pacific Cancer Research Consortium (PCRC), which was created to bring clinical trials and cancer care delivery research to community cancer treatment centers in the Western United States. We acknowledge the leadership of Dr. Charles Drescher, Ken Mattheus and Jeff St. De Lore in these efforts.
Related information
- NEJM article: Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer
- Learn more about the Pacific Cancer Research Consortium (PCRC)
- Providence Research Network Annual Report
