Item 8.01 Other Events.
On December 5, 2020, Kura Oncology, Inc. (the "Company") announced preliminary
results from its KOMET-001 Phase 1/2A clinical trial that were presented at an
oral presentation at the 2020 Annual Meeting of the American Society of
Hematology ("ASH"). As of the data cutoff date for the ASH presentation,
November 2, 2020, the trial had enrolled 12 patients with relapsed or refractory
acute myeloid leukemia ("AML"), of whom ten were evaluable for safety and
tolerability and eight were evaluable for efficacy. Clinical or biological
activity was reported in six of the eight efficacy-evaluable patients, including
two patients achieving a complete remission, one patient achieving a
morphological leukemia-free state, and one patient experiencing a marked
decrease in hydroxyurea requirements and having attained peripheral blood count
stabilization. As presented at ASH, KO-539 has been well tolerated with a
manageable safety profile to date. As of the data cutoff date, no drug
discontinuations due to treatment-related adverse events and no evidence of QTc
prolongation or other clinically significant EKG changes were reported.
Treatment related adverse effects (grade ³ 3) were reported to included
pancreatitis, increased lipase, decreased neutrophil count, tumor lysis syndrome
and deep venous thrombosis.
On December 5, 2020, representatives of the Company began providing presentation
materials (the "Presentation") to certain interested parties. A copy of the
Presentation is attached hereto as Exhibit 99.1 and incorporated herein by
reference.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
99.1 Presentation Materials of Kura Oncology, Inc.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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