2023 World Conference on Lung Cancer (Posters)-EP11.02. Phase I Study of Epacadostat in Combination with Sirolimus in Solid Tumors and PK Data.

EP11.02. Phase I Study of Epacadostat in Combination with Sirolimus in Solid Tumors and PK Data. - PDF(Abstract)

Pdf Summary

This study aimed to investigate the combination of two drugs, Epacadostat (E) and Sirolimus (S), in patients with solid tumors, including non-small cell lung cancer (NSCLC). Epacadostat is an inhibitor of Indoleamine 2,3 dioxygenase-1 (IDO1), which helps reverse immunosuppression and increase T cell proliferation. Sirolimus can suppress the expression of PD-L1 and Treg function. The study enrolled 15 patients, with 9 patients evaluable. No dose-limiting toxicity was observed. Adverse events were mostly grade 1 and 2, with a few grade 3 toxicities. The best response observed was stable disease in 3 patients, while 5 patients had disease progression. The PK data showed consistent levels of Epacadostat across the three dose cohorts. Sirolimus levels were also measured. Based on the results, the combination of Epacadostat and Sirolimus is feasible and tolerable, producing stable disease in 33% of patients. The PK data supports the accumulation of Epacadostat with repeat administration. The authors suggest that the combination of Sirolimus at 6mg/d for 7 days followed by 2mg/d with Epacadostat 400mg bid could be used in future research in phase II trials.

Asset Subtitle

chao Huang

Meta Tag

Speaker chao Huang

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

combination therapy

Epacadostat

Sirolimus

solid tumors

immunosuppression

T cell proliferation

IDO1 inhibitor

PD-L1 suppression

stable disease

PK data