1531P - Update results of anlotinib combined with TQB2450 (PD-L1 blockade) as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, multicenter, open-label phase II clinical trial

Background

Recent studies have demonstrated encouraging efficacy in patients with ESCC when combining PD-1 blockades with chemotherapy in the first-line setting. However, the safety profile of conventional chemotherapy remains unsatisfactory, suggesting the chemotherapy-free regimen a promising strategy. Anlotinib, a novel multitarget TKI primarily targeting VEGFR1-3, has shown therapeutic activity as first-line combination therapy or second-line monotherapy for ESCC patients in China. TQB2450 is a novel PD-L1 blockade developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Nanjing, China). This study aims to investigate the efficacy and safety of anlotinib plus TQB2450 as first-line therapy for patients with advanced ESCC.

Methods

Patients with previously untreated metastatic or locally advanced ESCC, whose age was between 18 and 75 years, with ECOG PS of 0 or 1 score and life expectancy of >3 months were inclusion criteria. Eligible patients were administered with anlotinib (12mg, po, d1∼14, q3w) plus TQB2450 (1200mg, iv, d1, q3w) until disease progression or unacceptable toxicity. The predefined sample size was 46. The primary endpoint was ORR, secondary endpoints included safety, PFS, DCR, DoR and OS.

Results

From Mar 2022 to Sep 2022, a total of 46 patients were enrolled. At the data cut-off date (Mar 2023), the preliminary ORR was 69.6% (95%CI: 54.2%∼82.3%), DCR was 93.5% (95%CI: 82.1%∼98.6%). At the data cut-off date, 9 pts discontinued treatment due to PD, the preliminary prognostic result exhibited that the median PFS of the 46 pts was 9.92 months (95%CI: 8.26∼11.58). Additionally, safety profile exhibited that the regimen was tolerable. The common grade ≥3 treatment-related adverse events in 46 patients were hypertension (7%), hyponatremia (4%), low white blood cell count (2%), neutrophil count decreased (2%), platelet count decreased (2%), intestinal obstruction (2%), haemoptysis (2%) and toothache (2%).

Conclusions

The preliminary results highlighted that anlotinib plus TQB2450 as a first-line therapy for advanced ESCC showed encouraging efficacy and manageable safety profile.

Clinical trial identification

NCT05038813.

Editorial acknowledgement

Legal entity responsible for the study

The First Affiliated Hospital of Zhengzhou University.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.