TY - JOUR
T1 - Pamiparib in combination with tislelizumab in patients with advanced solid tumours
T2 - results from the dose-expansion stage of a multicentre, open-label, phase I trial
AU - Friedlander, Michael
AU - Mileshkin, Linda
AU - Lombard, Janine
AU - Frentzas, Sophia
AU - Gao, Bo
AU - Wilson, Michelle
AU - Meniawy, Tarek
AU - Baron-Hay, Sally
AU - Briscoe, Karen
AU - McCarthy, Nicole
AU - Fountzilas, Christos
AU - Cervantes, Andres
AU - Ge, Ruimin
AU - Wu, John
AU - Spira, Alexander
PY - 2023/9/21
Y1 - 2023/9/21
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85165307185&partnerID=8YFLogxK
U2 - 10.1038/s41416-023-02349-0
DO - 10.1038/s41416-023-02349-0
M3 - Article
C2 - 37474720
AN - SCOPUS:85165307185
SN - 0007-0920
VL - 129
SP - 797
EP - 810
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 5
ER -