On March 28, 2023 Mount Sinai Medical Center (MSMC) reported the results of a clinical trial led by Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center in Miami Beach, Florida (Press release, Mount Sinai Hospital, MAR 28, 2023, View Source [SID1234629462]). The investigator-initiated phase II trial, sponsored by the GOG Foundation, investigated the combination of ribociclib and letrozole in patients with recurrent low-grade serous ovarian cancer (LGSOC) (GOG-3026) presenting positive results that will change the standard of care for this cancer moving forward. As the Principal Investigator for this trial, Dr. Slomovitz presented the results at The Society of Gynecologic Oncology’s 2023 Annual Meeting on Women’s Cancer in Tampa, Florida.
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Ribociclib and letrozole combination is active in patients with advanced or recurrent LGSOC: Phase II trial results:
ORR, PFS, DOR compare favorably to most active agents previously investigated.
In this trial, the reported response rate was 23%, the progression-free survival 19.1 months, and the duration of response of 19.1 months. Sixty-four percent of evaluable patients experienced a reduction in target tumor size.
"These results are promising. Women with this disease have limited treatment options. The progression-free survival and duration of response are both 6 months greater than what we have observed with the current standard treatments," stated Dr. Slomovitz. LGSOC is a rare subtype of ovarian cancer, which typically occurs in younger women and may arise from a non-invasive precursor disease (serous borderline tumor). Approximately 80% of women with LGSOC suffer disease recurrence following primary therapy. Traditional treatment options, including chemotherapy, hormonal therapy, and biologic targeted therapies, have limited clinical efficacy and short durations of response. In particular, response rates to chemotherapy range from 0-15%. Treatment options for women with recurrent disease remains an unmet need.
Dr. Slomovitz added, "Our next steps are to compare this regimen of ribociclib and letrozole vs the best current therapies in a head-to-head study. Hopefully this work can lead to an FDA approval for this combination."
Mount Sinai Medical Center is excited about this promising advancement for gynecologic cancer patients dealing with rare tumors. This is yet another opportunity to help transform the standard of care in gynecologic oncology.