Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial

Friedlander, M; Mileshkin, L; Lombard, J; Frentzas, S; Gao, B; Wilson, M; Meniawy, T; Baron-Hay, S; Briscoe, K; McCarthy, N; Fountzilas, C; Cervantes, A; Ge, R; Wu, J; Spira, A

Author(s): Friedlander, M; Mileshkin, L; Lombard, J; Frentzas, S; Gao, B; Wilson, M; Meniawy, T; Baron-Hay, S; Briscoe, K; McCarthy, N; Fountzilas, C; Cervantes, A; Ge, R; Wu, J; Spira, A;
Details: Publication Year 2023-09,Volume 129,Issue #5,Page 797-810
Journal Title: British Journal of Cancer
Publication Type: Research article
Abstract: BACKGROUND: The aim of this study was to investigate the antitumour activity, safety, and tolerability of pamiparib plus tislelizumab in patients with previously treated advanced solid tumours. METHODS: In this study, patients were enrolled into eight arms by tumour type. All received pamiparib 40 mg orally twice daily plus tislelizumab 200 mg intravenously every 3 weeks. The primary endpoint was objective response rate (ORR), assessed by the investigator per Response Evaluation Criteria in Solid Tumours v1.1. Secondary endpoints included duration of response (DoR), safety, and tolerability. RESULTS: Overall, 180 patients were enrolled. In the overall population, the ORR was 20.0% (range: 0-47.4 across study arms), with median DoR of 17.1 months (95% confidence interval [CI]: 6.2, not estimable [NE]). The highest ORR was observed in the triple-negative breast cancer (TNBC) arm (patients with BRCA1/2 mutations and/or homologous recombination deficiency) (ORR: 47.4%; median DoR: 17.1 months [95% CI: 3.0, NE]). Treatment-emergent adverse events (TEAEs) of >/=Grade 3 occurred in 61.7% of patients. Serious TEAEs occurred in 50.0% of patients. CONCLUSIONS: Pamiparib plus tislelizumab showed a variable level of antitumour activity in patients with advanced solid tumours, with the highest ORR in TNBC and was associated with a manageable safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT02660034.
Publisher: Springer Nature
Keywords: Humans; *BRCA1 Protein; *Triple Negative Breast Neoplasms; BRCA2 Protein; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Department(s): Medical Oncology
PubMed ID: 37474720
Publisher's Version: https://doi.org/10.1038/s41416-023-02349-0
Open Access at Publisher's Site: https://doi.org/10.1038/s41416-023-02349-0
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-10-19 04:37:32

Last Modified: 2023-10-19 04:37:56