Clin Cancer Res: Avelumab + Trabectedin Combination for Advanced Fat/Leiomyosarcoma

Leiomyosarcoma (LMS) and liposarcoma (LPS) express PD-L1, but are often resistant to PD-1/PD-L1 inhibitors (ICIs)
.

Trabectedin, a tetrahydroisoquinoline alkaloid with potent antitumor activity, is currently PDA approved for the treatment of leiomyosarcoma and liposarcoma

This study is a single-arm, open-label, Phase 1/2 trial to evaluate the efficacy and safety of trabectedin in combination with the anti-PD-L1 antibody Avelumab in the treatment of advanced leiomyosarcoma and liposarcoma
.

To evaluate the efficacy and safety of trabectedin combined with the anti-PD-L1 antibody Avelumab in the treatment of advanced leiomyosarcoma and liposarcoma
.

The Phase 1 phase evaluated the safety and feasibility of trabectedin (1, 1.
2, and 1.
5 mg/m2) in combination with standard-dose Avelumab
.

The primary endpoint of the Phase 2 phase was objective response rate (ORR)

Grade 3-5 Treatment-Related Adverse Reactions

Grade 3-5 treatment-related adverse reactions
Grade 3-5 treatment-related adverse reactions

A total of 33 patients were recruited: 24 leiomyosarcoma (6 uterine sarcoma, 18 non-uterine sarcoma) and 11 liposarcoma
.

In Phase 1, two dose-limiting toxicities were observed in each of six patients in the 1.
2 mg/m2 and 1.
5 mg/m2 dose groups of trabectedin

The recommended dose for Phase 2 is trabectedin 1.

The 6-month progression-free survival rate was 52%, and the median progression-free survival was 8.

Previous studies in which progression-free survival was superior to trabectedin deserves further investigation

 

Original source:

Original Source: Original Source:

Wagner Michael J, Zhang Yuzheng, Cranmer Lee D et al.

Wagner Michael J, Zhang Yuzheng, Cranmer Lee D et al.
A Phase 1/2 Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma.
[J] .
Clin Cancer Res, 2022, https://doi.
org/10.
1158/1078 -0432.
CCR-22-0240.
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