Background

Anlotinib, an antiangiogenic multi-target tyrosine kinase inhibitor, significantly improved clinical benefit in many solid tumours. TQB2450 is an engineered anti-programmed death-ligand 1 antibody. This study aimed to assess the safety and effect of TQB2450 plus anlotinib in patients with advanced solid tumour.

Methods

This phase Ib study, which included a dose-escalating phase and an expansion phase, enrolled patients with advanced or metastatic solid tumour who had standard treatment failure or no standard treatment between June 2019 and January 2020. Eligible patients were firstly enrolled into sequential dose-escalating cohorts including 10mg and 12mg anlotinib plus TQB2450 following the conventional 3+3 design. If the starting dose of 10mg anlotinib led to ≥2 dose-limiting toxicities (DLTs), 8mg anlotinib would be administered. After the dose-escalating phase completed, eligible patients were enrolled into the expansion cohort. The primary outcomes were safety and objective response rate (ORR).

Results

In the dose-escalating phase, the first 3 eligible patients received 10mg anlotinib plus TQB2450 had no DLTs in the first cycle, neither did the 3 patients who received 12mg anlotinib plus TQB2450. Then the expansion phase started, 16 patients were enrolled and received 12mg anlotinib plus TQB2450. Of the 22 patients included, there are 6 patients with small cell lung cancer (SCLC), 8 patients with non-small cell lung cancer, 2 patients with colorectal cancer, 2 patients with breast cancer, 2 patients with ovarian cancer, 1 patient with thymic carcinoma and 1 patient with cervical cancer. Of Those patients, ORR was 32.8% and Disease control rate was 81.8%. Four SCLC patient had PR and 1 SCLC patient had stable disease. Ten ≥3 grade AEs were observed (Table). Table: 532MO

The ≥3 grade AEs

Conclusions

12mg anlotinib plus TQB2450 showed an acceptable safety profile and promising results in patients with advanced solid tumour. The phase Ib study is ongoing to investigate the safety and effect.

Clinical trial identification

NCT03897283.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.