CLINICAL TRIAL PROGRAMS

Kura Oncology’s clinical trial programs represent the next step toward our goal of realizing the full potential of precision medicine. Our investigational trials are studying innovative therapeutic candidates with the potential to help patients with certain cancers lead better, longer lives.

INVESTIGATIONAL THERAPIES

Ziftomenib
A Menin Inhibitor

EXPERT PERSPECTIVES ON AML LATEST KOMET-001 DATA

Tipifarnib & KO-2806

LATEST FARNESYL TRANSFERASE INHIBITORS DATA

DISCOVER CLINICAL TRIAL PROGRAMS FOR:

ACUTE LEUKEMIAS

Acute myeloid leukemia (AML)

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GIST

Gastrointestinal stromal tumor

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HNSCC

Head and neck squamous cell carcinoma (HNSCC)

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OTHER SOLID TUMORS

Solid tumors

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MENIN INHIBITOR TRIALS: ZIFTOMENIB

Clinical trials studying ziftomenib in patients with acute leukemias and GIST

ZIFTOMENIB IN ACUTE LEUKEMIAS

AML is a genetically heterogenous disease.1 Two alterations observed in AML are KMT2A rearrangements and NPM1 mutations; about 5-10% of patients have translocations of the KMT2A gene, whereas ~30% of patients have NPM1 mutations with or without other gene mutations.2,3

While patients with NPM1-mutant (NPM1-m) AML have high response rates to first-line therapy, survival outcomes remain poor. Those who relapse have a dismal prognosis, with a median overall survival (OS) of 6.1 months (12-month OS: 30%) and median relapse-free survival (RFS) of 5.5 months (12-month RFS: 34%). Patients with KMT2A-rearranged (KMT2A-r) AML have a poor prognosis with high rates of resistance and relapse following current standard of care treatments, with a 5-year OS of <20%.4-7

Expert Perspectives on AML and Ziftomenib Clinical Trials

Harry Erba, MD, PhD

Dr. Erba discusses the KOMET-001 Phase 1b safety and tolerability data of ziftomenib, a menin inhibitor, for patients with R/R NPM1-m AML

/in ,
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Dr. Erba offers insight into the KOMET-007 Phase 1 trial and rationale for investigating ziftomenib in combination with standards of care for the treatment of patients with newly diagnosed or R/R NPM1-m or KMT2A-r AML

/in ,
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Amir T. Fathi, MD

Amer Zeidan, MBBS, MHS

  • 5-YEAR SURVIVAL RATE4-7

NPM1-m: ~50%

KMT2A-r: <20%

ENROLLMENT COMPLETED

Relapsed or Refractory AML
Phase 1/2

KOMET-001 is a Phase 1/2 study of ziftomenib in patients with relapsed or refractory (R/R) AML.

The R/R NPM1-m AML portion of the Phase 2 KOMET-001 trial has completed enrollment and is not currently recruiting.

FDA has granted ziftomenib Breakthrough Therapy Designation in R/R NPM1-m AML.

NCT04067336

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  • RECRUITING

Newly diagnosed AML relapsed or refractory AML
Phase 1

KOMET-007 is a Phase 1 study to assess the safety, tolerability, and preliminary clinical activity of ziftomenib in combination with venetoclax (1b only) and azacitidine (ven/aza) or standard induction cytarabine/daunorubicin (7+3) chemotherapy for the treatment of patients with NPM1-m or KMT2A-r AML.

NCT05735184

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  • RECRUITING

Relapsed or Refractory AML
Phase 1

KOMET-008 is a Phase 1 study to assess the safety, tolerability, and preliminary clinical activity of ziftomenib in combination with FLAG-IDA, LDAC, or gilteritinib for the treatment of patients with R/R NPM1-m or KMT2A-r AML.

NCT06001788

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NPM1–m AML

of patients with AML have NPM1 mutations with or without other gene mutations.3

KMT2A–r AML

of patients with AML have translocations of the KMT2A gene.2

ZIFTOMENIB IN GIST

Kura is evaluating ziftomenib, a menin inhibitor, in combination with imatinib for
advanced gastrointestinal stromal tumors (GISTs).

  • ENROLLING SOON

Gastrointestinal Stromal Tumor
Phase 1

KOMET-015 is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ziftomenib with imatinib in patients with advanced GIST imatinib failure.

NCT06655246

CONTACT KURA

FARNESYL TRANSFERASE INHIBITOR TRIALS: TIPIFARNIB & KO-2806

Clinical trials studying farnesyl transferase inhibitors (FTIs) in patients with HNSCC and other solid tumors

TIPIFARNIB IN HNSCC

The 5-year OS for patients with stage III or IV head and neck cancer is around 15-35%.8 Despite recent advances in treatment, including the incorporation of immunotherapy, prognosis remains poor—especially in patients with recurrent/metastatic (R/M) disease—with the median survival ranging from 6 to 15 months depending on patient- and disease-related factors.9-11

  • 5-YEAR SURVIVAL RATE9

Stage III/IV HNSCC: ~15-35%

  • RECRUITING

RELAPSED/METASTATIC HNSCC
Phase 1/2

KURRENT-HN is a Phase 1/2 open-label, dose escalation study of tipifarnib and alpelisib, a PI3K alpha inhibitor, to determine the safety and recommended dose and regimen for the treatment of adult patients with R/M HNSCC whose tumors are PIK3CA-dependent.

NCT04997902

CONTACT KURA

PIK3CA MUTATIONS OR AMPLIFICATIONS ARE FOUND IN

of patients with HNSCC.12

KO-2806 IN OTHER SOLID TUMORS

Kura is evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.

  • RECRUITING

FARNESYL TRANSFERASE INHIBITOR TRIAL OF KO-2806

FIT-001 is a Phase 1, first-in-human, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 as a monotherapy and in combination with cabozantinib in clear cell renal cell carcinoma (ccRCC) and with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC).

NCT06026410

CONTACT KURA

KO-2806

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REFERENCES

  • 1. Kumar CC. Genetic abnormalities and challenges in the treatment of acute myeloid leukemia. Genes Cancer. 2011;2(2):95-107. 2. Klossowski S, Miao H, Kempinska K, et al. Menin inhibitor MI-3454 induces remission in MLL1-rearranged and NPM1-mutated models of leukemia. J Clin Invest. 2020;130(2):981-997. 3. Prata PH, Bally C, Prebet T, et al. NPM1 mutation is not associated with prolonged complete remission in acute myeloid leukemia patients treated with hypomethylating agents. Haematologica. 2018;103(10):e455-e457. 4. Angenendt L, Röllig C, Montesinos P, et al. Chromosomal abnormalities and prognosis in NPM1-mutated acute myeloid leukemia: a pooled analysis of individual patient data from nine international cohorts. J Clin Oncol. 2019;37(29):2632-2642. 5. Venugopal S, Konopleva M, DiNardo CD, et al. NPM1 mutations do not retain a favorable prognostic impact in adults with advanced relapsed or refractory (R/R) acute myeloid leukemia (AML). Poster presented at: 2021 ASH Meeting on Hematologic Malignancies; September 2-3, 2021; virtual. Abstract 2287. 6. Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424-447. 7. Issa GC, Zarka J, Sasaki K, et al. Predictors of outcomes in adults with acute myeloid leukemia and KMT2A rearrangements. Blood Cancer J. 2021;11(9):162. 8. Ridge JA, Glisson BS, Lango MN. Head and neck tumors. February 18, 2011. Accessed April 4, 2023. https://www.cancernetwork.com/view/head-and-neck-tumors 9. Brockstein BE, Vokes EE. Treatment of metastatic and recurrent head and neck cancer. UpToDate. Updated February 27, 2023. Accessed April 4, 2023. https://www.uptodate.com/contents/treatment-of-metastatic-and-recurrent-head-and-neck-cancer/print 10. Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum- and cetuximab-refractory head and neck cancer: results from a single-arm, phase II study. J Clin Oncol. 2017;35(14):1542-1549. 11. Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375(19):1856-1867. 12. Dilmaghani NA, Safaroghli-Azar A, Pourbagheri-Sigaroodi A, Bashash D. The PI3K/Akt/mTORC signaling axis in head and neck squamous cell carcinoma: possibilities for therapeutic interventions either as single agents or in combination with conventional therapies. IUBMB Life. 2021;73(4):618-642.