The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201. - 2025
The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201.
Banerjee, Susana N; Van Nieuwenhuysen, Els; Aghajanian, Carolet al.
The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer a plain language summary of the Phase II clinica.pdf
Avutometinib; Defactinib; Plain Language Summary; RAMP 201; Recurrent Low-Grade Serous Ovarian Cancer
Abstract :
[en] What is this summary about?This plain language summary describes the results of the ENGOT-OV60/ GOG-3052/RAMP 201 clinical study, which were published in 2025. The Phase II study evaluated treatments for patients with a rare type of ovarian cancer, low-grade serous ovarian cancer (LGSOC). The study specifically involved those whose cancer came back or persisted, despite already having surgery and previous chemotherapy. Researchers investigated the effect of avutometinib on its own and in combination with defactinib to see which treatment would be more effective and to determine if both treatments were safe. They also investigated the combination of a lower dose of avutometinib with defactinib. All trial participants were tested for a specific KRAS genetic mutation (non-hereditary, also called somatic). The main goal of the study was to determine the confirmed objective response rate of each treatment. This is the percentage of patients whose cancer shrinks by at least 30% after treatment and maintains this shrinkage for at least 2 months. The study also closely monitored for any adverse events associated with each treatment and looked at other measures of treatment effectiveness.What were the results?The percentage of patients with an objective response was 31% in the combination treatment group and 17% in the avutometinib-only group. Amongst patients receiving the combination, the objective response rate was 44% in the group of participants with a KRAS mutation and 17% in the group without a KRAS mutation. The lower dose of avutometinib used in combination with defactinib was not as effective as the standard dose.In the standard dose combination treatment group, most adverse events were not severe (categorized as grade 1 or 2 on a scale of 0 to 5) and were managed with dose holds or dose reductions. The most frequent adverse events reported were nausea, increased creatine phosphokinase (CPK), diarrhea, peripheral edema, and rash. A total of 10% of participants discontinued treatment due to adverse events.What do the results mean?The results of the study support using the combination of avutometinib and defactinib as a treatment option for women with recurrent LGSOC.Clinical trial number: NCT06072781.
Disciplines :
Oncology
Author, co-author :
Banerjee, Susana N; The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, GTG-UK, London, United Kingdom
Van Nieuwenhuysen, Els; University Hospitals Leuven, Leuven Cancer Institute, BGOG, Leuven, Belgium
Aghajanian, Carol; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY ; Weill Cornell Medical College, New York, NY
D'Hondt, Véronique; Institut du Cancer de Montpellier (ICM) Val d'Aurelle Parc Euromedecine, Oncologie Médicale, GINECO, Montpellier, France
Monk, Bradley J; Florida Cancer Specialists, West Palm Beach, FL
Clamp, Andrew; Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, GTG-UK, Manchester, United Kingdom
Oaknin, Ana; Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
Ring, Kari; Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia, Charlottesville, VA
Colombo, Nicoletta; Università degli Studi di Milano Bicocca, Bicocca, Italy ; European Institute of Oncology, Milan, Italy
Holloway, Robert W; AdventHealth Cancer Institute, Orlando, FL
Rodrigues, Manuel; Department of Medical Oncology, Institut Curie, Paris, France ; DRUM Team, INSERM U830, Institut Curie, Paris, Franc
Chon, Hye Sook; Department of Gynecologic Oncology, H. Lee Moffitt Cancer Center, Tampa, FL
Gourley, Charlie; CRUK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, United Kingdom
Santin, Alessandro D; Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Gynecologic Oncology, Yale School of Medicine, New Haven, CT
Thaker, Premal H; Division of Gynecologic Oncology, Washington University School of Medicine and Siteman Cancer Center, St. Louis, MO
Gennigens, Christine ; Centre Hospitalier Universitaire de Liège - CHU > > Service d'oncologie médicale
Newman, Gregg; Sansum Clinic Healthcare, USO, Santa Barbara, CA
Salinas, Erin; Northwest Cancer Specialists, P.C., USO, Portland, OR
Youssoufian, Hagop; Verastem Oncology, Boston, MA
Moore, Kathleen N; Stephenson Oklahoma Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK
Lustgarten, Stephanie; Verastem Oncology, Boston, MA
O'Malley, David M; The Ohio State University, James Comprehensive Cancer Center, Columbus, OH
Van Gorp, Toon; University Hospitals Leuven, Leuven Cancer Institute, BGOG, Leuven, Belgium
Grisham, Rachel N; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY ; Weill Cornell Medical College, New York, NY
The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201.
