Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced final results from a Phase 2 study of
Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced final results from a Phase 2 study of tipifarnib as a monotherapy in patients with relapsed or refractory T-cell lymphoma, including an overall response rate (ORR) of 56% and a median overall survival of 32.8 months in heavily pretreated patients with angioimmunoblastic T-cell lymphoma (AITL).
The final results are being presented during an oral session today at the American Society of Hematology (ASH) Annual meeting in Atlanta. A copy of the presentation is available on the Company's website at www.kuraoncology.com.
"These data compare favorably to approved therapies for treatment of relapsed/refractory T-cell lymphoma, particularly in patients with AITL for whom there are few treatment options," said Thomas Witzig, M.D., a Hematologist at Mayo Clinic and the study's lead investigator.
A total of 65 patients with relapsed or refractory T-cell lymphoma were enrolled in the study, with a median of three prior regimens (range 1-8). Twenty-five patients (38%) received prior autologous stem cell transplant. The ORR among all efficacy-evaluable patients was 40% (23/58) and the median duration of response (DOR) was 4.6 months.
Notably, the ORR in patients with AITL, an aggressive form of T-cell lymphoma and a pre-specified subgroup in the trial, was 56% (18/32), including nine complete responses, with a median DOR of 7.8 months and a median overall survival of 32.8 months.
Tipifarnib was generally well-tolerated in this Phase 2 study, with adverse events consistent with its known safety profile. The most frequently observed treatment-related adverse events (all grades) were hematological (neutropenia, thrombocytopenia, anemia) and gastrointestinal (nausea, diarrhea), as well as fatigue.
"We continue to be encouraged by the growing body of data for tipifarnib in both solid tumors and hematologic malignancies," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "The clinical benefit demonstrated in late-stage patients with T-cell lymphoma, including heavily pretreated patients with AITL, underscore the potential of farnesyl transferase inhibition to drive clinical benefit in patients with cancer."
This multi-center, single-arm, open-label Phase 2 study was designed to evaluate tipifarnib as a monotherapy in adult patients with relapsed or refractory T-cell lymphoma. The primary objective of the study was to determine the antitumor activity by ORR. Secondary objectives included safety, DOR and progression-free survival, and exploratory analyses included overall survival and identification of potential biomarkers associated with tipifarnib activity.