Abstract 1748P
Background
Our previous retrospective study demonstrated that eribulin combined with ICIs and anlotinib, a multi-targeted antiangiogenic tyrosine kinase inhibitor has shown some efficacy in STS. In this study we further investigated the efficacy and safety of the above-mentioned regimen in patients (pts) with advanced soft tissue sarcoma.
Methods
This is a single-arm, phase II study. Pts with advanced or metastasis STS that has progressed on prior chemotherapy receive tislelizumab 200mg Q3W (d1, iv), eribulin 1.1 mg/m2 (d1, d8, iv) and anlotinib 12 mg (d1-d14, po) every three weeks for 6 cycles, followed by two of the maintenance regimen until disease progression, intolerable toxicity and other discontinuation criteria. The primary endpoint was ORR. Secondary endpoints included PFS, DCR, AEs, OS.
Results
From May 2023 to April 2024, 26 patients were enrolled. All received at least one treatment and one tumor assessment. Median age was 57 years, 61.5% (16/26) were female. 69.2% (18/26) had L-type sarcomas (including 5 liposarcoma [LPS] and 13 leiomyosarcoma [LMS]), and 30.8% (8/26) had non-L-type sarcomas. Pts had received a median of 1 (range 1-3) prior regimens and the median follow-up was 5.5 months. Median PFS and OS were not reached. PFS and OS rates at 12m were 53% and 61.8%, respectively. ORR and DCR were 30.8% (8/26) and 84.6% (22/26). 8 pts achieved either a complete or partial response with an averaged DOR of 6.8 months and were still in the study cohort. Among them, 6 were L-type sarcoma (5 LMS, 1 LPS). 20 patients (76.9%) experienced treatment related adverse events (TRAEs), the most common TRAEs were myelosuppression, liver function abnormality and thyroid dysfunction. Grade 3/4 TRAEs occurred in 23.1% of pts, with no grade 5 events.
Conclusions
Tislelizumab+eribulin+anlotinib was well tolerated and showed encouraging efficacy compared to retrospective controls.
Clinical trial identification
ChiCTR2300071221.
Editorial acknowledgement
Funding
BeiGene. Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1372P - Advanced non-small cell lung carcinoma in the era of immunotherapy: Survival and the risk of multiple primary malignancies
Presenter: Nahla Ali
Session: Poster session 06
1373P - Measuring PFS in clinical trials and observational studies of patients with NSCLC: A scoping review
Presenter: Marjon Verschueren
Session: Poster session 06
1374P - Analysis of evolution of patient reported side effects during treatment for advanced NSCLC
Presenter: Helena Linardou
Session: Poster session 06
1375P - Sequential ctDNA profiling in patients with advanced non-small cell lung cancer: An interim analysis of the COPE randomized study
Presenter: Antoine Italiano
Session: Poster session 06
Resources:
Abstract
1376P - Early detection of disease progression in NSCLC patients undergoing immunotherapy through ctDNA analysis
Presenter: Virginia Calvo de Juan
Session: Poster session 06
1377P - Association of anatomic proximity of brain parenchymal metastasis to the CSF space and upfront stereotactic radiosurgery to subsequent leptomeningeal metastasis development in brain metastatic NSCLC
Presenter: Shoaib Bashir
Session: Poster session 06
Resources:
Abstract
1378P - Improvements in stage IV non-small cell lung cancer survival differ by race in the US
Presenter: Oluwaseun Ayoade
Session: Poster session 06
1379P - c-Met protein overexpression and telisotuzumab vedotin efficacy by biopsy age, type, and region in the LUMINOSITY phase II study
Presenter: Jair Bar
Session: Poster session 06
1380P - PK/PD analysis of pembrolizumab, nivolumab and atezolizumab in NSCLC patients: The PIONeeR trial
Presenter: Joseph Ciccolini
Session: Poster session 06
1381P - Comparison between standard dose 75mg/m<sup>2</sup> and fixed dose at 50mg of cisplatin in the treatment of non-small cell lung cancer patients in term of response rate and toxicity profile
Presenter: Maher Salamoon
Session: Poster session 06