Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — ASH 2025
14 slides from Kura Oncology's conference presentation, 2025
Slide 1: Ziftomenib in Combination with Venetoclax and Azacitidine in R/R NPM1-m or KMT2A-r AML
Reused with permission from the American Society of Hematology. © 2025 The Authors. All rights reserved. Officially licensed by ASH for distribution via a corporate website by Kura. Ziftomenib in Combination with Venetoclax and Azacitidine in Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leuke
Slide 2: Ziftomenib Targets the Menin Pathway, a Foundational Target in AML
Ziftomenib Targets the Menin Pathway, a Foundational Target in AML • Leukemogenesis is driven by NPM1 mutations or KMT2A rearrangements in ~35–40% of AML cases1,2 • Nearly half of AML patients will develop relapsed/refractory (R/R) disease within a year, with a <20% expected response rate following
Slide 3: KOMET-007: Ongoing Phase 1 Combination Trial of Ziftomenib in R/R AML
KOMET-007: Ongoing Phase 1 Combination Trial of Ziftomenib in R/R AML Ziftomenib + Ven/Aza Combination (NCT05735184) Adult AML with Phase 1a: Phase 1b: NPM1-m or KMT2A-r Dose escalation Dose expansion / RP2D determination enroll independently Dose selection RP2D validation: Ziftomenib + Ven/Aza Dose
Slide 4: KOMET-007: Safety and Efficacy Populations: R/R AML
KOMET-007: Safety and Efficacy Populations: R/R AML Safety Population 83 Enrolled and treated with Ziftomenib 600 mg + Ven/Aza 51 NPM1-m 32 KMT2A-r No response assessment as of data cut (n=3) Response-Evaluablea (Efficacy) Population 48 NPM1-m 32 KMT2A-r 16 On treatmentb 5 On treatmentb 14 Received
Slide 5: Baseline Characteristics and Disposition: R/R AML
Baseline Characteristics and Disposition: R/R AML NPM1-m, 600 mg KMT2A-r, 600 mg All Patients, 600 mg n (%) (N=51) (N=32) (N=83) Median age, years (range) 65 (25–85) 56 (19–76) 62 (19–85) Female 23 (45) 17 (53) 40 (48) Race White 37 (73) 22 (69) 59 (71) Black / African American 5 (10) 2 (6) 7 (8) Ot
Slide 6: Safety and Tolerability of Ziftomenib with Ven/Aza: TEAEs in ≥25% of All Patients
Safety and Tolerability of Ziftomenib with Ven/Aza: R/R AML TEAEs in ≥25% of All Patients All TEAEs Ziftomenib-Related TEAEs NPM1-m, 600 mg KMT2A-r, 600 mg All Patients, 600 mg All Patients, 600 mg n (%) (N=51) (N=32) (N=83) (N=83) Any grade 49 (96) 32 (100) 81 (98) 48 (58) Nausea 19 (37) 15 (47) 34
Slide 7: Safety and Tolerability: Grade ≥3 TEAEs in ≥10% of All Patients
Safety and Tolerability of Ziftomenib with Ven/Aza: R/R AML Grade ≥3 TEAEs in ≥10% of All Patients Grade ≥3 Ziftomenib-Related All Grade ≥3 TEAEs TEAEs NPM1-m, 600 mg KMT2A-r, 600 mg All Patients, 600 mg All Patients, 600 mg n (%) (N=51) (N=32) (N=83) (N=83) Grade ≥3 46 (90) 30 (94) 76 (92) 33 (40)
Slide 8: Clinical Activity of Ziftomenib with Ven/Aza: R/R AML
Clinical Activitya of Ziftomenib with Ven/Aza: R/R AML NPM1-m, 600 mg KMT2A-r, 600 mg n (%) (N=48) (N=32) CRc 23 (48) 9 (28) Median time to first CRc, weeks (range) 3.9 (2.7–15.6) 4.0 (2.6–18.9) ORR 31 (65) 13 (41) CR 13 (27) 2 (6) CRh 6 (13) 5 (16) CRi 4 (8) 2 (6) MLFS 7 (15) 4 (13) PR 1 (2) 0 NR 1
Slide 9: Clinical Activity by Prior Venetoclax
Clinical Activitya by Prior Venetoclax No Prior Ven Prior Ven NPM1-m, 600 mg KMT2A-r, 600 mg NPM1-m, 600 mg KMT2A-r, 600 mg n (%) (N=23) (N=10) (N=25) (N=22) CRc 16 (70) 6 (60) 7 (28) 3 (14) Median time to first CRc, weeks (range) 3.8 (2.7–15.6) 3.4 (2.6–15.1) 4.3 (2.9–14.3) 9.3 (7.7–18.9) ORR 19 (8
Slide 10: Duration of Treatment and Clinical Outcomes: R/R AML (NPM1-m)
Duration of Treatment and Clinical Outcomes: R/R AML NPM1-m For NPM1-m, after a median follow-up of 27.4 weeks (range 3.3–69.1): • Median duration of CRc was 39.9 weeks (95% CI 16.1–NE) - Ven-naïve: 39.9 weeks (95% CI 12.9–NE) • 14 NPM1-m patients received HSCT, and 5 went onto ziftomenib maintenanc
Slide 11: Duration of Treatment and Clinical Outcomes: R/R AML (KMT2A-r)
Duration of Treatment and Clinical Outcomes: R/R AML KMT2A-r For KMT2A-r, after a median follow-up of 16.9 weeks (range 2.4–65.4): • Median duration of CRc was 12.4 weeks (95% CI 0.9–NE) est era ll es onse - Ven-naïve: 10.0 weeks (95% CI 0.9–NE) CR CRh • 2 KMT2A-r patients received HSCT, and both CR
Slide 12: ANC and Platelet Recovery in CRc Responders: R/R AML
ANC and Platelet Recovery in CRc Responders: R/R AML All Patients, 600 mg Median (range) (N=32)a Days to ANC reco ery ≥0.5 × 109/L 36 (0–136) Days to ANC reco ery ≥1.0 × 109/L 45 (34–145) Days to latelet count reco ery ≥50 × 109/L 27 (0–139) Days to latelet count reco ery ≥100 × 109/L 28 (0–243) • T
Slide 13: Conclusions
Conclusions • In the ongoing KOMET-007 study, ziftomenib 600 mg once daily in combination with Ven/Aza was well tolerated in R/R NPM1-m or KMT2A-r AML – Low rates of ziftomenib-related myelosuppression – No ziftomenib-related QTc prolongation was reported – One case of differentiation syndrome (NPM1
Slide 14: Acknowledgments
Acknowledgments • We would like to 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 group • Medical writing support was provided by Envis