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

被引：9

作者：

Friedlander, Michael ^{[1
,2
]}

Mileshkin, Linda ^{[3
,4
]}

Lombard, Janine ^{[5
]}

Frentzas, Sophia ^{[6
,7
]}

Gao, Bo ^{[8
]}

Wilson, Michelle ^{[9
]}

Meniawy, Tarek ^{[10
,11
]}

Baron-Hay, Sally ^{[12
,13
]}

Briscoe, Karen ^{[14
]}

McCarthy, Nicole ^{[15
]}

Fountzilas, Christos ^{[16
]}

Cervantes, Andres ^{[17
,18
]}

Ge, Ruimin ^{[19
]}

Wu, John ^{[20
]}

Spira, Alexander ^{[21
,22
,23
]}

机构：

[1] Univ New South Wales, Clin Sch, Randwick, NSW, Australia

[2] Prince Wales Hosp, Dept Med Oncol, Randwick, NSW, Australia

[3] Univ Melbourne, Dept Med Oncol, Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

[4] Univ Melbourne, Sir Peter MacCallum Dept Oncol, Melbourne, Vic, Australia

[5] Calvary Mater Newcastle, Med Oncol, Newcastle, NSW, Australia

[6] Monash Hlth, Dept Med Oncol, Melbourne, Vic, Australia

[7] Monash Univ, Fac Med Nursing & Hlth Sci, Melbourne, Vic, Australia

[8] Blacktown Hosp, Med Oncol Dept, Sydney, NSW, Australia

[9] Auckland City Hosp, Dept Canc & Blood, Auckland, New Zealand

[10] Linear Clin Res, Dept Med Oncol, Nedlands, WA, Australia

[11] Univ Western Australia, Nedlands, WA, Australia

[12] Royal North Shore Hosp, Dept Med Oncol, St Leonards, NSW, Australia

[13] GenesisCare, Melbourne, Vic, Australia

[14] Mid North Coast Canc Inst, Dept Med Oncol, Coffs Harbour, NSW, Australia

[15] Icon Canc Ctr Wesley, Dept Med Oncol, Auchenflower, Qld, Australia

[16] Roswell Pk Comprehens Canc Ctr, Dept Med, Div GI Med & Early Phase Clin Trial Program, Buffalo, NY USA

[17] Univ Valencia, INCLIVA Biomed Res Inst, Hosp Clin Univ, Dept Med Oncol, Valencia, Spain

[18] Inst Salud Carlos III, CIBERONC, Madrid, Spain

[19] BeiGene Beijing Co Ltd, Dept Clin Dev, Beijing, Peoples R China

[20] BeiGene USA Inc, Dept Biostat, San Mateo, CA USA

[21] Virginia Canc Specialists Res Inst, Dept Med Oncol, Fairfax, VA USA

[22] NEXT Oncol Virginia, Fairfax, VA USA

[23] US Oncol Res, The Woodlands, TX USA

来源：

BRITISH JOURNAL OF CANCER | 2023年 / 129卷 / 05期

关键词：

METASTATIC BREAST-CANCER; PARP INHIBITOR; ANTITUMOR-ACTIVITY; OVARIAN; OLAPARIB; CHEMOTHERAPY; PD-1/PD-L1; EXPRESSION; RUCAPARIB;

D O I：

10.1038/s41416-023-02349-0

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 40mg orally twice daily plus tislelizumab 200mg 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.

引用

页码：797 / 810

页数：14

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