Abstract 1744P
Background
Several immune checkpoint inhibitors (ICIs) have become the standard of care for patients with advanced urothelial carcinoma (aUC) that progressed after platinum-based chemotherapy. Nab-paclitaxel is increasingly employed in aUC patients. The efficacy and safety of camrelizumab (ICI) plus nab-paclitaxel in platinum-resistant unresectable local advanced/metastatic urothelial carcinoma was investigated in this study.
Methods
This multicentre, single-arm, phase 2 study enrolled patients who previous treated with at less one platinum-based systemic therapy. Patients received 200 mg camrelizumab on day 1 (D1), and 125 mg/m2 nab-paclitaxel on D1 and D8, on a 21-day cycle, until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) according to the Response Evaluation Criteria in Solid Tumors (RECIST, V1.1). This study is registered with chinadrugtrials.org.cn, number CTR2000033820.
Results
By January 2022, 20 eligible patients were enrolled. The median age was 65 years, 13 patients (65%) were male, and 11 patients (55%) were bladder urothelial carcinoma (BUC). After a median follow-up of 8.5 months, 11 patients (55%) have a progression disease. The median PFS was 5.81 months (95% confidence interval [CI] 3.48 to not reached [NR]). The objective response rate (ORR) was 25% (95% CI 8.6% to 49.1%) with 1 patient achieved complete response and 4 patients achieved partial responses. Two patients (1%) had durable response over one year. Adverse events (AEs) of any grade occurred in 18 patients (90%). Grade ≥3 AEs occurred in 10 patients (50 %), 6 patients (30%) reported treatment related hospitalization/prolonged hospitalization. One patient experienced severe immune-related pneumonia.
Conclusions
Camrelizumab in combination with nab-paclitaxel for platinum-resistant aUC patients exhibited favorable anti-tumor activities and tolerable in the preliminary analyses. Additional randomized trials are warranted for the combination regimen.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.