Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Technical Presentation (December 2024)
15 slides from Kura Oncology's technical presentation, December 2024
Slide 1: Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r AML
Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007 Amer M. Zeidan,1 Eunice S. Wang,2 Ghayas C. Issa,3 Harry Erba,4 Jessica Kaplan Altman,5 Suresh Kumar Balasubramanian,6,7 Stephen Anthony Strickland,
Slide 2: Ziftomenib Targets the Menin Pathway, a Foundational Target in AML
Ziftomenib Targets the Menin Pathway, a Foundational Target in AML • In ~35–40% of AML, leukemogenesis is driven by either NPM1 mutations or KMT2A rearrangements,1,2 which are upstream regulators of key genes critical for AML (eg, HOXA9/MEIS1)3 • KMT2A (MLL) and NPM1 sit upstream from major AML targ
Slide 3: KOMET-007: Ongoing Phase 1 Combination Trial of Ziftomenib in Newly Diagnosed Adverse-Risk AML
KOMET-007: Ongoing Phase 1 Combination Trial of Ziftomenib in Patients with Newly Diagnosed Adverse-Riska AML Ziftomenib / 7+3 combination (NCT05735184) • Ziftomenib started on Cycle 1 Day 8 and administered continuously thereafter. Cytarabine administered on Cycle 1 Days 1–7; daunorubicin on Cycle
Slide 4: KOMET-007 Phase 1a in 1L AML: Safety and Efficacy Populations
KOMET-007 Phase 1a in 1L AML: Safety and Efficacy Populations ITT (Safety) Population: Enrolled and treated N=51 24 NPM1-m 27 KMT2A-r 1 NPM1-m – no response 4 KMT2A-r – no response assessment as of data cut assessment as of data cut Response-Evaluablea (Efficacy) Population: 23 NPM1-m 23 KMT2A-r 21
Slide 5: Baseline Characteristics and Disposition: 1L AML (N=51)
Baseline Characteristics and Disposition: 1L AML (N=51) NPM1-m KMT2A-r All Patients 200 mg 400 mg 600 mg Total 200 mg 400 mg 600 mg Total (N=51) (n=8) (n=7) (n=9) (n=24) (n=10) (n=9) (n=8) (n=27) Median age, years (range) 60 (18–74) 65 (43–74) 66 (55–68) 66 (60–68) 66 (43–74) 53 (31–73) 51 (28–60) 4
Slide 6: Safety and Tolerability of Ziftomenib in Combination with 7+3: TEAEs in ≥30% of Patients
Safety and Tolerability of Ziftomenib in Combination with 7+3 in 1L AML (N=51) TEAEs in ≥30% of All Patients NPM1-m KMT2A-r All Patients 200 mg 400 mg 600 mg Total 200 mg 400 mg 600 mg Total TEAEs, n (%) (N=51) (n=8) (n=7) (n=9) (n=24) (n=10) (n=9) (n=8) (n=27) Any Grade 48 (94) 8 (100) 6 (86) 8 (89
Slide 7: Safety and Tolerability: Grade ≥3 TEAEs in ≥10% of All Patients
Safety and Tolerability of Ziftomenib in Combination with 7+3 in 1L AML (N=51) Grade ≥3 TEAEs in ≥10% of All Patients NPM1-m KMT2A-r All Patients 200 mg 400 mg 600 mg Total 200 mg 400 mg 600 mg Total TEAEs, n (%) (N=51) (n=8) (n=7) (n=9) (n=24) (n=10) (n=9) (n=8) (n=27) Grade ≥3 46 (90) 8 (100) 6 (8
Slide 8: Clinical Activity in All Response-Evaluable 1L Patients (N=46)
Clinical Activity in All Response-Evaluablea 1L Patients (N=46) • Historically, only 33% of 7+3 treated newly diagnosed Adverse-Risk AML patients achieve CRc, with a median overall survival of ~6 months1-2 NPM1-m KMT2A-r All Patients 200 mg 400 mg 600 mg Total 200 mg 400 mg 600 mg Total Response, n
Slide 9: Case Study
Case Study 60-yr-old Female with Newly Diagnosed NPM1-m AML Treated with Ziftomenib and 7+3 • Screening marrow: blasts 8%, CD34– NPM1+ AML • Day 21 marrow: 30% morphologic blasts, but now CD34+ NPM1– (IHC) • Days 22–24: Platelet count recovering, decision to hold off salvage therapy and repeat marro
Slide 10: Duration of Treatment & Preliminary Clinical Outcomes in NPM1-m 1L AML
Duration of Treatment & Preliminary Clinical Outcomes in NPM1-m 1L AML • For NPM1-m, after a median follow-up of 31 weeks (range 17–63): 200 mg - Median duration of CR was not reached - Median OS was not reached - 5 NPM1-m patients received HSCT (200 mg n=3, 400 mg n=2). Thus far, 2 went onto ziftom
Slide 11: Duration of Treatment & Preliminary Clinical Outcomes in KMT2A-r 1L AML
Duration of Treatment & Preliminary Clinical Outcomes in KMT2A-r 1L AML • For KMT2A-r, after a median follow-up of 19 weeks (range 2–43): 200 mg - Median duration of CR was not reached - Median OS was not reached - 10 KMT2A-r patients received HSCT (200 mg n=6, 400 mg n=3, 600 mg n=1). Thus far, 5 w
Slide 12: ANC and Platelet Recovery in CRc Responders
ANC and Platelet Recovery in CRc Responders NPM1-m + KMT2A-r 200 mg 400 mg 600 mg Median (range) n=17 n=13 n=12 Days to ANC ≥0.5x10 9/L, Cycle 1 32 (20–40) 27 (20–40) 28 (19–38) Days to ANC ≥1.0x10 9/L, Cycle 1 33 (21–62) 28 (20–40) 28 (20–48) Days to Platelets ≥50x10 9/L, Cycle 1 28 (15–62) 26 (15–
Slide 13: Conclusions
Conclusions • In the ongoing KOMET-007 study, ziftomenib combined with cytarabine and daunorubicin (7+3) was well tolerated across all dose levels in patients with newly diagnosed adverse-risk NPM1-m and KMT2A-r AML - No DLTs or ziftomenib-associated QTc prolongation were reported - On-target DS occ
Slide 14: KOMET-017: Phase 3 Ziftomenib Pivotal 1L Combination
KOMET-017: Phase 3 Ziftomenib Pivotal 1L Combination Expected to start in mid-2025 • Randomized registration-enabling Phase 3 trial in both fit and unfit 1L AML to initiate in 2025 - Includes two independently powered Phase 3, randomized, double-blind, placebo-controlled studies - Populations: Adult
Slide 15: Acknowledgements
Acknowledgements • The patients, their families, and caregivers • KOMET-007 study investigators and their study teams • This study was sponsored by Kura Oncology, Inc. • Medical writing support was provided by Oxford PharmaGenesis Inc., with funding from Kura Oncology, Inc.
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