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Clinical Trial
. 2021 Dec;163(3):465-472.
doi: 10.1016/j.ygyno.2021.09.025. Epub 2021 Oct 9.

Results of TRIO-14, a phase II, multicenter, randomized, placebo-controlled trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-ganitumab in newly diagnosed epithelial ovarian cancer

G E Konecny  1 , A E Wahner Hendrickson  2 , T M Davidson  2 , B J Winterhoff  3 , S Ma  4 , S Mahner  5 , J Sehouli  6 , P A Fasching  7 , G Feisel-Schwickardi  8 , M Poelcher  9 , L D Roman  10 , A Rody  11 , B Y Karlan  12 , S A Mullany  3 , H Chen  13 , I L Ray-Coquard  14 , D M Provencher  15 , A Yachnin  16 , P H Cottu  17 , J A Glaspy  13 , P Haluska  18 , D J Slamon  13
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Free article
Clinical Trial

Results of TRIO-14, a phase II, multicenter, randomized, placebo-controlled trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-ganitumab in newly diagnosed epithelial ovarian cancer

G E Konecny et al. Gynecol Oncol. 2021 Dec.
Free article

Abstract

Purpose: Insulin-like growth factor (IGF) signaling is implicated in pathogenesis and chemotherapy resistance of epithelial ovarian cancer (EOC). We explored efficacy and safety of adding ganitumab, a monoclonal antibody targeting IGF-1R, to carboplatin/paclitaxel (CP) chemotherapy in patients with primary EOC.

Design: Patients were randomly assigned to receive CP/ganitumab (18 mg/kg q3w) or CP/placebo for 6 cycles followed by 6 cycles of single agent ganitumab/placebo maintenance therapy as front-line therapy. Primary endpoint was progression free survival. Secondary endpoints were time to progression and overall survival. Pretreatment samples were prospectively collected for retrospective biomarker analyses.

Results: 170 patients enrolled. 165 patients assessable for toxicity. Median PFS was 15.7 months with CP/ganitumab and 16.7 months with CP/placebo (HR 1.23; 95% CI 0.82-1.83, P = 0.313). All grade neutropenia (84.1% vs 71.4%), thrombocytopenia (75.3% vs 57.1%) and hyperglycemia (15.9% vs 2.6%) were more common in the ganitumab group compared to the placebo group. Ganitumab/placebo related serious adverse events were reported in 26.1% of the patients with ganitumab and in 6.5% with placebo. Non-progression related fatal events were more common with ganitumab (5 versus 2 patients). The ganitumab group experienced more dose delays which resulted in lower relative dose intensity of chemotherapy in the experimental group. In an exploratory model IGFBP2 expression was predictive of ganitumab response (treatment interaction; PFS, P = 0.03; OS, P = 0.01).

Conclusion: Addition of ganitumab to CP chemotherapy in primary EOC did not improve PFS. Our results do not support further study of ganitumab in unselected EOC patients.

Keywords: Ganitumab; IGFR1 inhibitor; Insulin-like growth factor; Ovarian cancer; Targeted therapy.

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Declaration of Competing Interest The authors declare no potential conflicts of interest.

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