A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Trial ID # NCT04625270: RAMP 201
Phase II
Drug Class Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/RAF-MEK
Drug Name Avutometinib
Alternate Drug Names CH5126766, Raf/MEK dual kinase inhibitor RO5126766, RO5126766, CKI27, VS-6766
Drugs in Trial Avutometinib, Defactinib
Eligible Participant

Recurrent low grade serous ovarian cancer

Patients Enrolled

62 patients; Avu: 33, median 3 prior therapies (1-10); Avu+Def: 31, median 4 prior therapies (1-11)

Therapy Setting


Study Design

Open-Label, Randomized


ORR, DCR, evaluated per RECIST


Results from PART A:
Avu+Def (n=31) vs Avu (n=33):

ORR: 45 (13PR, n=29) vs 10% (1CR, 2PR, n=30)
DCR: 93 (13PR, 13SD) vs 90% (1CR, 2PR, 25SD)

KRAS MUT: Avu+Def (n=15) vs Avu (n=15):
ORR: 60 (9PR) vs 13% (1CR, 1PR)
DCR: 100 (9PR, 6SD) vs 93% (1CR, 2PR, 11SD)

KRAS WT: Avu+Def (n=14) vs Avu (n=16):
ORR: 29 (4PR) vs 6% (1PR)
DCR: 79 (4PR, 7SD) vs 88% (1PR, 13SD)

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: elevated CPK (19 vs 23%)


The combination of avutometinib with defactinib yields encouraging response rates with a well tolerated safety profile in women with heavily pretreated recurrent LGSOC regardless of KRAS status and with prior MEK inhibitor treatment


Banerjee SN et al. Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC). J Clin Oncol 41, 2023 (suppl 16; abstr 5515)

Banerjee SN et al. Poster

Banerjee S et al. Avutometinib plus defactinib in recurrent low-grade serous ovarian cancer: A subgroup analysis of ENGOT-OV60/GOG3052/RAMP 201 Part A. SGO (2024)

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