On December 3, 2015 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company, reported that new data from a Phase 3 trial of tipifarnib, the company’s lead product candidate, will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in Orlando, December 5-8, 2015 (Press release, Kura Oncology, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119854 [SID:1234508388]).

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The accepted abstract is listed below and is available online on the ASH (Free ASH Whitepaper) conference website: View Source

Tipifarnib As Maintenance Therapy in Acute Myeloid Leukemia (AML) Improves Survival in a Subgroup of Patients with High Risk Disease. Results of the Phase 3 Intergroup Trial E2902 (abstract # 1308)
Date & Time: Saturday, December 5, 2015 at 5:30 p.m. ET
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I

Location: Hall A, Level 2 (Orange County Convention Center)

The abstract describes results from the ECOG-ACRIN Cancer Research Group’s (ECOG-ACRIN) Phase 3 trial E2902, which compared tipifarnib as maintenance therapy to observation only with respect to disease-free survival in patients with AML in second or subsequent complete remission, in complete remission following primary induction failure, or patients 60 years of age or older in first complete remission. See www.clinicaltrials.gov using identifier NCT00093470.

Researchers in these groups designed and conducted trial E2902 independent of Kura Oncology and with sole sponsorship from the National Cancer Institute, part of the National Institutes of Health. Between August 2004 and December 2009, 144 patients with AML were enrolled in the study at multiple medical facilities (sites) across the United States, as well as one site in Israel and one site in Peru, through ECOG-ACRIN, the Alliance for Clinical Trials in Oncology and SWOG.

The median age of patients was 69 years (range 28-86), 73 patients (51%) were male and 135 patients (94%) were white. Ninety-one percent of patients were 60 years of age or older. A majority of patients enrolled on the study (70%) were in first complete remission (CR). Eighty patients (56%) had post remission chemotherapy prior to randomization. A total of 73 patients were enrolled onto the treatment arm (Arm A), while 71 patients were enrolled onto the observation arm (Arm B).

The primary endpoint of the study was an analysis of disease-free survival (DFS) on an-intent-to-treat basis. The median DFS for arms A and B was 8.87 months and 5.26 months respectively (p=0.058, HR 0.760). When restricted to eligible patients only (n=134), the DFS for arms A and B was 10.81 versus 5.26 months, respectively (p=0.019, HR 0.690). An unplanned subgroup analysis was performed by gender. The median DFS for male patients (n=73) was 5.36 versus 5.91 months for arms A and B respectively (p=0.868, HR 1.320) and 12.09 versus 3.91 months for female patients (n=71) (p=0.0002, HR=0.408). Hematological toxicity was seen in both arms but was less frequent in the observation arm.

While the primary endpoint for improved disease-free survival was not reached when evaluating all randomized patients, when restricted to eligible patients only, a statistically significant improvement in DFS was observed. Moreover, an unplanned subgroup analysis by gender demonstrated an improvement in DFS and overall survival (OS) for females who were enrolled on the study, which persists on multivariate analysis. Possible explanations for the gender differences in DFS and OS include the use of flat dosing rather than body-surface area (BSA) based dosing. Given what appears to be a potentially clinically relevant benefit, the authors concluded that further evaluation of this agent is warranted.

"The results are exciting and suggest that tipifarnib, when administered in this fashion, provides a survival benefit to a significant group of patients with AML who otherwise have a high risk of relapse," said lead investigator Selina M. Luger, MD from the University of Pennsylvania. "Further studies should be done to better understand which patients can benefit or if alternate dosing would allow this benefit to extend to a larger population."

"We are encouraged by the outcomes of this study," said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology. "We are in discussions with the study investigators and other key opinion leaders to determine the appropriate next steps for development of tipifarnib in this and other indications."

The ECOG-ACRIN Cancer Research Group is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. Its research is supported primarily by federal funding through the National Cancer Institute. www.ecog-acrin.org.