448MO - A clinical study of the safety and efficacy of toripalimab in combination with anilotinib for the treatment of recurrent glioblastoma (GBM)

Background

The treatment of recurrent glioblastoma(rGBM) remains one of the greatest challenges, severely affecting patient survival and quality of life. By modulate the characteristics of immune microenvironment, anti-vascular therapy are expected to improve the anti-PD-1 antibody therapeutic efficacy of rGBM. Toripalimab is a humanized anti-PD-1 monoclonal antibody, which can effectively block the interaction between B7-H1 and B7-DC to inhibit tumor growth. Anlotinib is a novel small molecule multi-target tyrosine kinase receptor inhibitor. Which can effectively inhibit the activity of VEGFR1-3, c-Kit, PDGFRβ, FGFR and other kinases. Therefore, toripalimab combined with Anlotinib is expected to improve the patients overall survival. This study is proposed for patients with rGBM treated by toripalimab in combination with Anlotinib with the primary study endpoint of prolonging survival in rGBM.

Methods

This trial is a prospective, open, single arm, phase II clinical study evaluating the safety and efficacy of the toripalimab in combination with Anlotinib in the treatment of rGBM. The primary objective is to evaluate the overall survival of patients. The secondary objectives are to evaluate the progression-free survival, clinical benefit rate, and safety of this regimen in patients with rGBM. This study was approved by the Ethics Committee of TangDu Hospital (No. 202006-22, Clinical Trial Registration No. ChiCTR2000039175).

Results

A total of 54 patients were enrolled from 2020.8 to 2024.4, including 33 males and 21 females, with a mean age of 53 years. At the time of enrolment, the mean KPS of all patients was 70. All patients had received STUPP regimen. The average number of recurrences is 2.3. 22 patients had received any types of anti-vascular therapy prior to enrolment. The median overall survival was 4.96 months, progression-free survival was 3.33 months, and the clinical benefit rate was 66%. A total of 21 cases of treatment-related AE occurred, including 5 cases of grade 3 or higher.

Conclusions

Toripalimab in combination with Anlotinib was effective in prolonging rGBM patient survival, while treatment-related toxicity was acceptable.

Clinical trial identification

ChiCTR2000039175.

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.