Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Technical Presentation (2026)
18 slides from Kura Oncology's technical presentation, 2026
Slide 1: Ziftomenib Combined With Intensive Induction (7+3) for Newly Diagnosed AML: KOMET-007 Long-Term Results
# S130 Ziftomenib Combined With Intensive Induction (7+3) for Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia (AML): Long-Term Results From the KOMET-007 Trial Amer M Zeidan1, Eunice Wang2, Harry Erba3, Stephen Strickland4, Ghayas Issa5, Suresh K Balasubramanian6, Gail J Roboz7, Christine M
Slide 2: Amer M Zeidan – Presenter Disclosures
Amer M Zeidan – Presenter Disclosures Serve(d) as director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Akesobio; Agios; Amgen; AstraZeneca/Alexion, Astellas; BioCryst; Beigene; Boehringer Ingelheim; Celgene/BMS; Chiesi/Cornerstone biopharma; Daiichi Sankyo; Dr Reddy; Ep
Slide 3: Ziftomenib Targets the Menin Pathway, a Foundational Target in AML
Ziftomenib Targets the Menin Pathway, a Foundational Target in AML • NPM1 mutations and KMT2A rearrangements drive leukemogenesis in ~35–40% of AML1,2 • Ziftomenib – a potent, selective, once-daily oral menin inhibitor – is approved by the U.S. FDA as monotherapy for adults with R/R NPM1-m AML. It h
Slide 4: KOMET-007: Ongoing Combination Trial of Ziftomenib in Newly Diagnosed AML
KOMET-007: Ongoing Combination Trial of Ziftomenib in Newly Diagnosed AML Ziftomenib / 7+3 Combination PHASE 1a: HIGH-RISKa AML PHASE 1b: ALL IC-ELIGIBLE AML Dose Escalation Dose Expansion / RP2D Determination Induction: Ziftomenib / 7+3 Induction: Ziftomenib / 7+3 Consolidation: Ziftomenib / HiDAC/
Slide 5: KOMET-007 Patient Populations: Newly Diagnosed AML
KOMET-007 Patient Populations: Newly Diagnosed AML 99 Enrolled and treated with Ziftomenib 600 mg QD / 7+3 combination • As of Apr 10, 2026, 99 patients (49 NPM1-m, 50 KMT2A-r) with newly diagnosed AML were enrolled 50 KMT2A-r and treated with ziftomenib 600 mg 49 NPM1-m orally once daily and 7+3 •
Slide 6: Baseline Characteristics
Baseline Characteristics NPM1-m KMT2A-r All Patients n (%) (N=49) (N=50) (N=99) Median age, years (range) 60 (30–71) 43 (18–70) 53 (18–71) Female 25 (51) 31 (62) 56 (57) Race White 36 (73) 32 (64) 68 (69) Non-White 3 (6) 7 (14) 10 (10) Unknowna 10 (20) 11 (22) 21 (21) ECOG PS 0–1 44 (90) 48 (96) 92
Slide 7: Safety and Tolerability of Ziftomenib with 7+3
Safety and Tolerability of Ziftomenib with 7+3 TEAEs in ≥30% of All Patients NPM1-m KMT2A-r All Patients Ziftomenib-related n (%) (N=49) (N=50) (N=99) (N=99) • Ziftomenib safety profile in Any grade 49 (100) 50 (100) 99 (100) 85 (86) combination with intensive Febrile neutropenia 30 (61) 37 (74) 67
Slide 8: Safety and Tolerability of Ziftomenib with 7+3
Safety and Tolerability of Ziftomenib with 7+3 Grade ≥3 TEAEs in ≥10% of All Patients NPM1-m KMT2A-r All Patients Grade ≥3 Grade ≥3 AEs of Interest Ziftomenib-related (N=49) (N=50) (N=99) n (%) (N=99) Differentiation syndrome (DS): Any grade ≥3 46 (94) 49 (98) 95 (96) 52 (53) • 4 Gr3 DS cases (4%; 1
Slide 9: Clinical Activity of Ziftomenib with 7+3
Clinical Activity of Ziftomenib with 7+3 NPM1-m KMT2A-r All Patients (N=49) (N=50) (N=99) n (%) CRc 47 (96) 45 (90) 92 (93) ORR 48 (98) 46 (92) 94 (95) CR 46 (94) 41 (82) 87 (88) CRh 1 (2) 1 (2) 2 (2) CRi 0 3 (6) 3 (3) MLFS 1 (2) 1 (2) 2 (2) PR 0 0 0 NR 1 (2) 3 (6) 4 (4) NE 0 1 (2) 1 (1) CR MRD nega
Slide 10: Central Molecular MRD Negativity: Newly Diagnosed NPM1-m AML
Central Molecular MRD Negativity: Newly Diagnosed NPM1-m AML Central MRD Central MRD n/N (%) (Threshold <0.1%) (Threshold <0.01%) CRc MRD negativity ratea 31/39 (79) 22/39 (56) Median time to MRD negativity, months (range) 2.2 (0.7–2.6) 2.3 (0.8–3.1) Timing of MRD negativityb: By Cycle 1 10/31 (32)
Slide 11: ANC and Platelet Recovery in CRc Responders
ANC and Platelet Recovery in CRc Responders NPM1-m KMT2A-r All Patients (N=47) (N=45) (N=92) Median days (IQR), Cycle 1 ANC ≥0.5 x 109/L 28 (21–32) 27 (25–29) 27 (23–30) ANC ≥1.0 x 109/L 28 (27–35) 28 (26–35) 28 (26–35) Platelets ≥50 x 109/L 23 (21–29) 26 (22–29) 25 (21–29) Platelets ≥100 x 109/L 28
Slide 12: Duration of Treatment and Clinical Outcomes
Duration of Treatment and Clinical Outcomes NPM1-m After a median follow-up of 17.6 months (range 1.0–23.5): • Median duration of CR was not reached - 80% duration of CR at 12 months • 10 NPM1-m patients received HSCT • 31 NPM1-m patients entered maintenance treatment - 8 after on-study HSCT - 23 wi
Slide 13: Duration of Treatment and Clinical Outcomes
Duration of Treatment and Clinical Outcomes KMT2A-r After a median follow-up of 11.0 months (range 0.9–21.9): • Median duration of CR was 12.0 months (95% CI 6.0–NE) and follow-up continues • 32 KMT2A-r patients received HSCT • 22 KMT2A-r patients entered ziftomenib maintenance - 21 after on-study H
Slide 14: Overall Survival
Overall Survival NPM1-m After a median follow-up of 17.6 months (range 1.0–23.5): • Median OS was not reached - NPM1-m: 94% OS rate at 12 months • Median age was 60 years • 90% (44/49) of NPM1-m patients remained alive and continued on studya - 60-day mortality: 2% (1/49) • 12-month OS with intensiv
Slide 15: Overall Survival
Overall Survival KMT2A-r After a median follow-up of 11.0 months (range 0.9–21.9): • Median OS was not reached - KMT2A-r: 71% OS rate at 12 months • Median age was 43 years • 62% (31/50) of KMT2A-r patients remained alive and continued on studya - 60-day mortality: 4% (2/50) aPatients on treatment o
Slide 16: Conclusions
Conclusions In KOMET-007, ziftomenib 600 mg QD combined with 7+3 was well tolerated with a safety profile consistent with previous reports • 4 cases (4%) of Gr3 differentiation syndrome (1 NPM1-m, 3 KMT2A-r; no Gr4); all successfully resolved with SAFETY protocol-specified mitigation and 3 continued
Slide 17: KOMET-017: Phase 3 Ziftomenib Pivotal Newly Diagnosed Combination Studies
KOMET-017: Phase 3 Ziftomenib Pivotal Newly Diagnosed Combination Studies KOMET-017-NIC: Non-intensive therapya – Ziftomenib + venetoclax/azacitidine combo Two independently Arm A Ziftomenib Patients Primary endpoints powered, registration- R Venetoclax + Azacitidine • CR • NPM1-m AML enabling, rand
Slide 18: Acknowledgments
Acknowledgments • We thank all the patients, their families, and their caregivers, as well as the KOMET-007 study investigators and their study teams • This study was sponsored by Kura Oncology, Inc., in partnership with Kyowa Kirin Co., Ltd. • Medical writing support was provided by Catriona Thomso