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RAMP 201

Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201

Phase 2N = 115NCT04625270

Population
Recurrent measurable low-grade serous ovarian cancer after at least one line of platinum chemotherapy; 115 patients received the go-forward combination, with a median of 3 prior lines (hormonal 86%, bevacizumab 51%, MEK inhibitor 22%)
Design
Phase 2, open-label study. Patients with recurrent measurable low-grade serous ovarian cancer after at least one line of platinum chemotherapy, stratified by KRAS mutation status, were randomly assigned to oral avutometinib 4.0 mg twice weekly or avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily; the combination was selected as the go-forward regimen for expansion. Primary end point ORR by blinded independent central review.
Primary endpoint
ORR
Arms
  • Avutometinib plus defactinib (experimental, n = 115): Avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily
  • Avutometinib (experimental): Avutometinib 4.0 mg twice weekly
People
Banerjee SN
Show the numbers
Results reported for RAMP 201
EndpointAnalysisAvutometinib plus defactinib / AvutometinibControlEffect
ORRGo-forward combination group (115 treated; 109 in the efficacy table)primaryBanerjee 202531% (23–41%)—Confirmed ORR by blinded independent central review; data cutoff 30 June 2024; 34 of 109 efficacy-evaluable patients (full text Table 2). The combination group pools Parts A, B and C (Part A randomised avutometinib alone against the combination); the paper also reports the avutometinib-alone group.
ORRKRAS-mutant cohort of the combination group (n=57 in Table 2)exploratoryBanerjee 202544%—Stratification subgroup; 25 of 57 patients.
ORRKRAS wild-type cohort of the combination group (n=52 in Table 2)exploratoryBanerjee 202517%—Stratification subgroup; 9 of 52 patients.
DORCombination group, patients with a confirmed responseprimaryBanerjee 2025median 31.1 months (14.8–31.1)—Secondary end point.
PFSCombination group (all)exploratoryBanerjee 2025median 12.9 months (10.9–20.2)—Secondary end point; single-arm data.
PFSKRAS-mutant cohort of the combination groupexploratoryBanerjee 2025median 22 months (11.1–36.6)—Subgroup.
PFSKRAS wild-type cohort of the combination groupexploratoryBanerjee 2025median 12.8 months (7.4–18.4)—Subgroup.
Results reported for RAMP 201
EndpointAnalysisAvutometinib plus defactinib / AvutometinibControlEffect
ORRGo-forward combination group (115 treated; 109 in the efficacy table)primaryBanerjee 202531% (23–41%)—Confirmed ORR by blinded independent central review; data cutoff 30 June 2024; 34 of 109 efficacy-evaluable patients (full text Table 2). The combination group pools Parts A, B and C (Part A randomised avutometinib alone against the combination); the paper also reports the avutometinib-alone group.
ORRKRAS-mutant cohort of the combination group (n=57 in Table 2)exploratoryBanerjee 202544%—Stratification subgroup; 25 of 57 patients.
ORRKRAS wild-type cohort of the combination group (n=52 in Table 2)exploratoryBanerjee 202517%—Stratification subgroup; 9 of 52 patients.
DORCombination group, patients with a confirmed responseprimaryBanerjee 2025median 31.1 months (14.8–31.1)—Secondary end point.
PFSCombination group (all)exploratoryBanerjee 2025median 12.9 months (10.9–20.2)—Secondary end point; single-arm data.
PFSKRAS-mutant cohort of the combination groupexploratoryBanerjee 2025median 22 months (11.1–36.6)—Subgroup.
PFSKRAS wild-type cohort of the combination groupexploratoryBanerjee 2025median 12.8 months (7.4–18.4)—Subgroup.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0204060Months (modelled)
  • Avutometinib plus defactinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAvutometinib plus defactinib
0100.0%
1965.5%
3941.9%
5827.5%
7817.6%
Illustrative — modelled from reported values, not trial data. PFS, exploratory.
0%25%50%75%100%051015202530Months (modelled)
  • Avutometinib plus defactinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAvutometinib plus defactinib
0100.0%
865.1%
1642.3%
2427.5%
3217.9%
Primary publication: Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, et al. Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025;43(25):2782-2792. PubMedDOI

Appears in

Sources

  1. Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, et al. Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025;43(25):2782-2792.

    PubMedDOI