Clinical outcome and biomarker assessments of a multi-centre phase II trial assessing niraparib with or without dostarlimab in recurrent endometrial carcinoma

Ainhoa Madariaga, Swati Garg, Nairi Tchrakian, Neesha C. Dhani, Waldo Jimenez, Stephen Welch, Helen MacKay, Josee-Lyne Ethier, Lucy Gilbert, Xuan Li, Angela Rodriguez, Lucy Chan, Valerie Bowering, Blaise Clarke, Tong Zhang, Ian King, Gregory Downs, Tracy Stockley, Lisa Wang, Smitha Udagani, Amit M. Oza and Stephanie Lheureux ()
Additional contact information
Ainhoa Madariaga: University Health Network
Swati Garg: University Health Network
Nairi Tchrakian: University of Toronto
Neesha C. Dhani: University Health Network
Waldo Jimenez: Juravinski Cancer Centre
Stephen Welch: London Regional Cancer Program
Helen MacKay: Sunnybrook Health Sciences Centre
Josee-Lyne Ethier: Kingston Health Sciences Cancer Centre
Lucy Gilbert: McGill University Health Centre, Royal Victoria Hospital
Xuan Li: University Health Network
Angela Rodriguez: University Health Network
Lucy Chan: University Health Network
Valerie Bowering: University Health Network
Blaise Clarke: University of Toronto
Tong Zhang: University Health Network
Ian King: University Health Network
Gregory Downs: University Health Network
Tracy Stockley: University Health Network
Lisa Wang: University of Toronto
Smitha Udagani: University Health Network
Amit M. Oza: University Health Network
Stephanie Lheureux: University Health Network

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: Abstract This multi-centre, non-randomized, open-label, phase II trial (NCT03016338), assessed niraparib monotherapy (cohort 1, C1), or niraparib and dostarlimab (cohort 2, C2) in patients with recurrent serous or endometrioid endometrial carcinoma. The primary endpoint was clinical benefit rate (CBR), with ≥5/22 overall considered of interest. Secondary outcomes were safety, objective response rate (ORR), duration of response, progression free survival and overall survival. Translational research was an exploratory outcome. Potential biomarkers were evaluated in archival tissue by immunohistochemistry and next generation sequencing panel. In C1, 25 patients were enrolled, and CBR was 20% (95% CI: 9–39) with median clinical benefit duration of 5.3 months. The ORR was 4% (95% CI: 0–20). In C2, 22 patients were enrolled, and the CBR was 31.8% (95% CI: 16–53) with median clinical benefit duration of 6.8 months. The ORR was 14% (95% CI: 3–35). No new safety signals were detected. No significant association was detected between clinical benefit and IHC markers (PTEN, p53, MMR, PD-L1), or molecular profiling (PTEN, TP53, homologous recombination repair genes). In conclusion, niraparib monotherapy did not meet the efficacy threshold. Niraparib in combination with dostarlimab showed modest activity.

Date: 2023
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DOI: 10.1038/s41467-023-37084-w

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