Kura Oncology (NASDAQ:KURA) provided updated interim data from its Phase 2 trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
In-licensed from Janssen in December 2014, tipifarnib is an orally bioavailable, selective inhibitor of farnesyl transferase.
The Phase 2 trial was designed to determine the efficacy, safety and biomarkers of activity of tipifarnib in patients with relapsed or refractory PTCL. The trial included two expansion cohorts: patients with angioimmunoblastic T-cell lymphoma (AITL) characterized by high levels of CXCL12 gene expression; and PTCL patients with a single nucleotide variation in the CXCL12 gene.
The study achieved its primary endpoint with a 45% and 42% overall response rate in the AITL and PTCL expansion cohorts, respectively.
“These data represent the first prospective validation of CXCL12 pathway biomarkers to enrich for clinical activity of tipifarnib in PTCL,” Troy Wilson, Kura’s president and CEO, said in a statement.
“We believe these data support the potential to register tipifarnib in both the AITL and PTCL patient populations, and we look forward to seeking regulatory feedback on next steps for this program,” he added.