NEW YORK – Kura Oncology reported positive interim data from its ongoing Phase II trial of its lead drug candidate, tipifarnib, in the treatment of angioimmunoblastic T-cell lymphoma (AITL). The results from the trial were presented at the American Society of Hematology (ASH) Annual meeting in Orlando on Sunday.
Kura Oncology is a clinical-stage biotech company focused on investigating precision medicine candidates for cancer. Tipifarnib is an inhibitor of farnesyl transferase (a Ras protein) and serves as a standalone, orally delivered treatment for patients with AITL. It was in-licensed from Janssen in December 2014.
Kura wants to identify subsets of patients with specific cancer genetics and tumor biology that would benefit from tipifarnib.
The drug was reported to be relatively well-tolerated in the Phase II trial as of the Nov. 11 data cutoff date. A total of 26 patients with relapsed or refractory AITL were enrolled in all stages of the trial, 20 of which were evaluated for efficacy.
For the average trial participant, tipifarnib is their fourth treatment regimen.
The objective response rate of those evaluated was 50 percent. From those who responded to the drug, five achieved a complete response (CR) and five achieved a partial response (PR), and three patients experienced disease stabilization.
Next-generation sequencing of 19 patient tumors showed that 10 carried C336R/Q386E mutations in the killer-cell immunoglobulin-like receptor (KIR) 3DL2, an immune checkpoint receptor. Of the 10 patients with KIR3DL2 variants, four achieved a CR and three achieved a PR.
Last November, the US Patent and Trademark Office issued a new patent for tipifarnib as a method of treating patients with AITL, providing exclusivity in the United States to 2037.
US Food and Drug Administration end-of-Phase II (EOP2) meeting minutes indicated that the current trial design may sufficiently support a New Drug Application (NDA) seeking accelerated approval of tipifarnib for patients with AITL and AITL-like histologies, both with and without KIR3DL2 mutations.
Following approval, Kura plans to enroll 128 patients in a Phase II registration-directed trial of tipifarnib for relapsed or refractory AITL and related lymphomas in 2020.
The trial will assess efficacy in terms of overall response rate in all patients enrolled and for patients who carry KIR3DL2 mutations. Patients will be enrolled based on a positive pathological diagnosis of AITL and AITL-like histologies. The status of having the KIR3DL2 mutation will be determined retrospectively.
In late afternoon Monday trading on the Nasdaq, shares of Kura Oncology were up around 2 percent at $15.93.