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.
Br J Cancer
; 129(5): 797-810, 2023 09.
Article
en En
| MEDLINE
| ID: mdl-37474720
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Proteína BRCA1
/
Neoplasias de la Mama Triple Negativas
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
Br J Cancer
Año:
2023
Tipo del documento:
Article
País de afiliación:
Australia