Abstract 224P
Background
For locally advanced upper tract urothelial carcinoma (UTUC), no evidence proved the effectiveness and safety of neoadjuvant immunotherapy combined with chemotherapy. Toripalimab is an innovative anti-PD-1 monoclonal antibody approved in China across multiple cancer indications. The current trial aims to investigate the effectiveness and safety of neoadjuvant toripalimab combined with chemotherapy in patients with locally advanced UTUC.
Methods
This is a single-arm, phase 2 prospective trial. This trial aims to recruit 59 patients aged 18-75 years with cT2-4aN0-2M0 UTUC. Patients receive toripalimab (240mg p.o.) plus gemcitabine (1000mg/m2 on D1 and D8) and cisplatin (75mg/m2, D1) every 3 weeks for 3-4 cycles before radical nephroureterectomy (RU). Tumor response is determined according to RECIST 1.1 criteria. The primary outcome is pathologic complete response (pCR), which was defined as the absence of invasive cancer or in situ disease in the kidney and ureter after RU (ypT0N0M0).
Results
11 patients have been recruited in this trial. 9 patients had completed neoadjuvant combination therapy and successfully underwent RU. 3 out of the 9 patients (33.3%) achieved pCR after neoadjuvant combination therapy and 4 out of the 9 patients (44.4%) attained pathologic partial response. No treatment-related adverse event was observed among all patients.
Conclusions
Neoadjuvant toripalimab combined with chemotherapy appears be effective and well-tolerated for patients with locally advanced UTUC. This trial is continuing to recruit patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Y. Bao.
Funding
Shanghai Junshi Biosciences Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
581P - The associations between afatinib-related adverse events and survival outcomes in patients with lung cancer
Presenter: Wen-Chen Tang
Session: Poster Display
Resources:
Abstract
582P - Furmonertinib treatment in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A real-world study
Presenter: Haiyang Chen
Session: Poster Display
Resources:
Abstract
583P - RHBDL2 promotes non-small cell lung cancer metastasis and osimertinib resistance by activating the RAS/MEK/ERK signaling pathway through interaction with FGFR
Presenter: jun Deng
Session: Poster Display
Resources:
Abstract
584P - Upfront aumolertinib for preventing symptomatic central nervous system(CNS) metastases in EGFR-mutant non-small cell lung cancer without baseline CNS metastasis
Presenter: Tangfeng Lv
Session: Poster Display
Resources:
Abstract
585P - Real-world outcomes in patients with non-small cell lung cancer with EGFR exon 20 insertion mutations receiving mobocertinib
Presenter: Tony S.K. Mok
Session: Poster Display
Resources:
Abstract
586P - Clinical validation of a multiplex polymerase chain reaction (mPCR) assay to identify patients (pts) with NSCLC suitable for mobocertinib treatment
Presenter: Caicun Zhou
Session: Poster Display
Resources:
Abstract
587P - Exploring the prevalence and characteristics of human epidermal growth factor receptor 2 (HER2) alterations in non-small cell lung cancer: Analysis from a Malaysian cohort
Presenter: Ning Yi Yap
Session: Poster Display
Resources:
Abstract
588P - First real-world study with HER2 ADC in treating HER2-altered non-small cell lung cancer
Presenter: Kaihua Lu
Session: Poster Display
Resources:
Abstract
590P - A retrospective study of the prevalence and clinical outcomes of KRAS G12C mutated advanced non-small cell lung cancer (NSCLC) in Australian patients (pts)
Presenter: Ben Markman
Session: Poster Display
Resources:
Abstract
591P - The utility of next generation sequencing for KRAS gene variants prevalence in cytological and tissue samples in real-world NSCLC patients: A large single institution real-world study
Presenter: Adam Pluzanski
Session: Poster Display
Resources:
Abstract