A Phase II Trial of Ribociclib (LEE011) Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum

Trial ID # NCT03673124
Phase II
Drug Class Hormonal Therapy: Aromatase
Drug Name Letrozole
Alternate Drug Names Femara
Drugs in Trial Letrozole, Ribociclib
Eligible Participant

Recurrent low grade serous ovarian cancer

Patients Enrolled

48, median 1 prior therapy (0-3)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Efficacy

ORR: 23% (11PR, n=42)
DCR: 79%
DoR: 19.1 months
PFS: 19.1 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: decreased neutrophils (44%)

Conclusion

The combination of letrozole plus ribociclib demonstrates promising activity in women with recurrent LGSOC

Reference

Slomovitz B et al. GOG 3026 A Phase II Trial of Letrozole + Ribociclib in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum: A GOG Foundation Study. SGO (2023) abstract 10
https://www.clearityfoundation.org/wp-content/uploads/2023/10/GOG-3026-Ribociclib-and-letrozole-SGO-2023.pdf

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