Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer.

Abstract

BACKGROUND:

IGF signaling has been implicated in the pathogenesis and progression of ovarian carcinoma (OC). Single agent activity and safety of ganitumab (AMG 479), a fully human monoclonal antibody against IGF1R that blocks binding of IGF1 and IGF2, were evaluated in patients with platinum-sensitive recurrent OC.

METHODS:

Patients with CA125 progression (GCIG criteria) or measurable disease per RECIST following primary platinum-based therapy received 18 mg/kg of ganitumab q3w. The primary endpoint was objective response rate (ORR) assessed per RECIST 1.1 by an independent radiology review committee (IRC) and/or GCIG CA125 criteria. Secondary endpoints included clinical benefit rate (CBR), progression free survival (PFS) and overall survival (OS).

RESULTS:

61 pts. were accrued. Objective responses were seen in 5/61 patients (ORR 8.2%, 95% CI, 3.1-18.8) with 1 partial response (PR) by RECIST and 2 complete responses (CR) as well as 2 PR by CA125 criteria. CBR was 80.3% (95% CI, 67.8-89.0%). The median PFS according to RECIST by IRC was 2.1 months (95% CI, 2.0-3.1). The median PFS per RECIST IRC and/or CA125 was 2.0 months (95% CI, 1.8-2.2). The median OS was 21 months (95% CI, 19.5-NA). The most common overall adverse events were fatigue (36.1%) and hypertension (34.4%). Grade 1/2 hyperglycemia occurred in 30.4% of patients. Hypertension (11.5%) and hypersensitivity (8.2%) were the most frequent grade 3 adverse events.

CONCLUSIONS:

IGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients.

• Authors: T M Davidson, C L Lebreton, A E Wahner Hendricksen, H J Atkinson, M C Larson, A L Oberg, D M Provencher, J A Glaspy, B Y Karlan, D J Slamon, G E Konecny, I L Ray-Coquard
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 170 Pg. 221-228 (03 2023) ISSN: 1095-6859 [Electronic] United States
• PMID: 36709663 (Publication Type: Clinical Trial, Phase II, Multicenter Study, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2023 Elsevier Inc. All rights reserved.

Chemical References

• ganitumab
• Antibodies, Monoclonal, Humanized
• Antibodies, Monoclonal

Topics

• Humans
• Female
• Antibodies, Monoclonal, Humanized
• Antibodies, Monoclonal (adverse effects)
• Ovarian Neoplasms (drug therapy)