Ritu Salani, MD, highlights data from the RUBY trial supporting the FDA approval of dostarlimab/chemotherapy for primary advanced endometrial cancer.
CancerNetwork® spoke with Ritu Salani, MD, about the expanded FDA approval of dostarlimab-gxly (Jemperli) in combination with carboplatin/paclitaxel for patients with primary advanced or recurrent endometrial cancer.
Salani, a board-certified gynecologic oncologist and director of Gynecologic Oncology at the University of California, Los Angeles Health, discussed the clinical benefit the dostarlimab combination showed for patients with endometrial cancer, particularly those with mismatch repair-deficient (dMMR) tumors, in the phase 3 RUBY trial (NCT03981796). Data leading to the approval showed a statically significant progression-free survival (PFS) and overall survival (OS) benefit in patients with dMMR or microsatellite-instability high (MSI-H) endometrial cancer, as well as for those across the overall population.
Noting the significant impact dostarlimab had on survival benefit without significant added toxicity, which investigators reported as early as March 2023, Salani said it was “wonderful” to have a relatively short turnaround time in making the combination therapy available for patients with primary advanced or recurrent endometrial cancer. Beyond the particular benefit among patients with dMMR tumors, she expressed the need to improve outcomes for patients with mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumors, who did not experience as much of a pronounced benefit from treatment with dostarlimab.
Salani also addressed the role of immunotherapy in subsequent lines of treatment following frontline therapy. Being thoughtful about sequencing agents in this setting may be an optimal strategy to give patients the greatest survivability and quality of life. She also considered alternative treatment strategies for certain patients, such as those with pMMR tumors.
“The thing that is interesting is the study highlighted patients who had residual disease or measurable disease present when they were getting this therapy, and that seems to be where the most significant impact [is],” Salani said. “Seeing more data on the right selection of patients will be really important. There are other avenues of treatment for these patient populations, particularly the pMMR population, where you might see some other therapies that may have an equally profound impact as immunotherapy. Maybe that will lend itself to leading immunotherapy for second-line treatment, if needed.”
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy. News release. FDA. August 1, 2024. Accessed August 15, 2024. https://tinyurl.com/mtr6tpyp