Elevar Therapeutics has reported the Phase II clinical trial results of its small-molecule tyrosine kinase inhibitor (TKI) rivoceranib in progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) patients.
The open-label Study RM-202 of the orally administered TKI was carried out at 11 sites in the US and South Korea.
It has been designed to investigate the therapy’s safety and efficacy in patients with progressive R/M ACC.
Study RM-202 evaluated rivoceranib in 80 patients, including 53 (66.3%) based in the US.
Within six months before the trial, all the participants demonstrated tumour progression.
An overall response rate (ORR) of 15.1% was observed in the trial, and the remaining 85% of patients had a tumour size reduction, though not an endpoint of the trial.
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Elevar Therapeutics CEO Saeho Chong said: “With every participant exhibiting a recent growing lesion upon entering this Phase II trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC.
“Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process.”
In this trial, 52% of subjects reported a response according to CHOI (size or density), which is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only).
Irrespective of previous vascular endothelial growth factor (VEGFR) therapy, median progression-free survival (mPFS) of nine months was observed versus published data of a baseline of 2.8 months for R/M ACC.
Furthermore, the adverse event profile of rivoceranib was found to be similar to other TKIs.
Excluding China, Elevar has global commercialisation rights for the therapy, which obtained orphan drug designation in the US.