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
Phase II
Drug Class Signaling Pathway Inhibitors: Integrins-FAK/FAK
Drug Name Defactinib
Alternate Drug Names VS-6063, PF-04554878
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


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

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