TY - JOUR
T1 - The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer
T2 - a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201
AU - Banerjee, Susana N.
AU - Van Nieuwenhuysen, Els
AU - Aghajanian, Carol
AU - D’Hondt, Véronique
AU - Monk, Bradley J.
AU - Clamp, Andrew
AU - Prendergast, Emily
AU - Oaknin, Ana
AU - Ring, Kari
AU - Colombo, Nicoletta
AU - Holloway, Robert W.
AU - Rodrigues, Manuel
AU - Chon, Hye Sook
AU - Gourley, Charlie
AU - Santin, Alessandro D.
AU - Thaker, Premal H.
AU - Gennigens, Christine
AU - Newman, Gregg
AU - Salinas, Erin
AU - Youssoufian, Hagop
AU - Moore, Kathleen N.
AU - Lustgarten, Stephanie
AU - O’Malley, David M.
AU - Van Gorp, Toon
AU - Grisham, Rachel N.
N1 - Publisher Copyright:
© 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2025
Y1 - 2025
N2 - Plain Language Summary: 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 KRASgenetic 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.
AB - Plain Language Summary: 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 KRASgenetic 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.
KW - Avutometinib
KW - Defactinib
KW - Plain Language Summary
KW - RAMP 201
KW - Recurrent Low-Grade Serous Ovarian Cancer
UR - https://www.scopus.com/pages/publications/105025686538
U2 - 10.1080/14796694.2025.2595130
DO - 10.1080/14796694.2025.2595130
M3 - Article
C2 - 41384753
AN - SCOPUS:105025686538
SN - 1479-6694
VL - 21
SP - 3859
EP - 3871
JO - Future Oncology
JF - Future Oncology
IS - 30
ER -