tenalisib + romidepsin

**Tenalisib + romidepsin** is a combination regimen of two drugs: tenalisib, a selective inhibitor of phosphoinositide-3-kinase delta/gamma (PI3K δ/γ) and salt-inducible kinase 3 (SIK3); and romidepsin, a histone deacetylase (HDAC) inhibitor. This combination has shown synergistic anti-tumor potential in preclinical studies and favorable safety and efficacy in a multicenter phase I/II clinical trial for adults with relapsed/refractory T-cell lymphomas (both peripheral T-cell lymphoma [PTCL] and cutaneous T-cell lymphoma [CTCL]). Tenalisib is administered orally, twice daily, and romidepsin is given intravenously on days 1, 8, and 15 of a 28-day cycle. The mechanism of action involves inhibition of PI3K δ/γ and SIK3 (tenalisib), impairing tumor cell signaling and survival, and inhibition of HDAC (romidepsin), leading to altered gene expression and apoptosis of malignant cells. The combination did not significantly alter the pharmacokinetics of either agent and was well tolerated, with an objective response rate in TCL patients of up to 75% in PTCL and 53.3% in CTCL, supporting further clinical development[1][2][3].

Other names

tenalisib + romidepsin