A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Trial ID # NCT03531645
Phase II
Drug Class Cell Cycle Inhibitors: CDK4/6
Drug Name Abemaciclib
Alternate Drug Names Bemaciclib, LY2853219, CDK4/6 Dual Inhibitor LY2835219, Verzenio
Drugs in Trial Abemaciclib, Fulvestrant
Eligible Participant

Newly diagnosed stage III/IV unresectable low grade serous ovarian cancer

Patients Enrolled

15

Therapy Setting

First-line

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, evaluated per RECIST

Efficacy

ORR: 60% (1CR, 7PR)
DCR: 100% (1CR, 7PR, 7SD)

7 patients w/ IDS:
100% achieved optimal cytoreduction at IDS
(71% R0, 29% R1)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: overall (13.3%)

Conclusion

Neoadjuvant treatment with fulvestrant and abemaciclib is tolerable and demonstrates unprecedented response and complete gross resection rates in Low Grade Serous ovarian cancer

Reference

Cobb LP et al. A pilot phase II study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low-grade serous carcinoma. J Clin Oncol 40, 2022 (suppl 16; abstr 5522)
https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.5522

Cobb LP et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2022/10/Neoadjuvant-Fulvestrant-and-Abemaciclib-LGS-ASCO-poster-2022-scaled.jpeg

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