The GOG Foundation, Inc. (GOG) announced positive results from an investigator-initiated phase II trial, sponsored by the GOG, investigating the combination of ribociclib and letrozole in patients with recurrent low-grade serous ovarian cancer (LGSOC) (GOG-3026). The results were presented at The Society of Gynecologic Oncology’s 2023 Annual Meeting on Women’s Cancer ™ in Tampa, Florida.
Ribociclib and letrozole combination is active in patients with advanced or recurrent LGSOC. The phase II trial results show ORR, PFS, DOR compare favourably to most active agents previously investigated.
In this trial, the reported response rate was 23%, the progression-free survival was 19.1 months, and the duration of response of 19.1 months. Sixty-four percent of evaluable patients experienced a reduction in target tumour 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 Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center in Miami Beach, Florida, and the Principal Investigator for this trial.
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 tumour). 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.
“For years, we have not had a great understanding of this disease. We have learned that effective treatments are often similar to those used to treat women with hormone-positive breast cancer,” added David M. Gershenson, MD, professor at MD Anderson Cancer Center in Houston, Texas, and Co-Principal Investigator.
“The GOG Foundation sponsors investigator-initiated trials with the intent of improving the outcomes for patients with gynecologic cancers. This trial is an example of achieving this focused mission. The trials that we support and sponsor are meant to help patients with gynaecologic cancers to not only live longer but with a better quality of life”, stated Larry Copeland, MD, professor at The Ohio State University and President of the GOG Foundation.
Dr Slomovitz added, “The next steps will be to compare this regimen of ribociclib and letrozole versus the best current therapies in a head-to-head study. Hopefully, this work can lead to an FDA approval for this combination.”
The GOG Foundation is excited about this promising advancement for gynaecologic cancer patients dealing with rare tumours. This is yet another opportunity to help transform the standard of care in gynecologic oncology.
Source: The GOG Foundation Inc