Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — ESMO 2023
9 slides from Kura Oncology's conference presentation, 2023
Slide 1: A phase 2 study evaluating tipifarnib in mHRAS R/M HNSCC (AIM-HN)
A phase 2 study evaluating tipifarnib in mHRAS, recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) (AIM-HN) Alan L. Ho, MD, PhD Memorial Sloan Kettering Cancer Center, New York, NY, USA Alan L. Ho1, Douglas Adkins2, Glenn J. Hanna3, Justine Yang Bruce4, Ahn Myung-Ju5, Lara I
Slide 2: Declaration of Interests
Declaration of Interests Alan L. Ho, MD, PhD Consulting/Advisory Boards/DSMC Affyimmune, Ayala, Coherus, Eisai, Exelixis, ExpertConnect, Klus Pharma, Kura Oncology, McGivney Global Advisors, Merck, National Cancer Institute, Prelude Therapeutics, Remix Therapeutics, Rgenta, Coherus, Speakers’ Bureau
Slide 3: HRAS Mutations are Biomarkers for Tipifarnib Activity
HRAS Mutations are Biomarkers for Tipifarnib Activity • Mutant HRAS is an oncogenic driver mutation observed in a small sub-set of HNSCC patients Normal FTase Tipifarnib Inhibits FTase • HRAS is uniquely dependent on post-translational farnesylation for membrane localization - required for activatio
Slide 4: Study Design
Study Design AIM-HN 174 (3.4%) Tipifarnib 600 mg BID Key Eligibility Criteria1 (days 1-7 and 15-21 in a 28-day cycle) mHRAS HNSCC • Tumor missense HRAS mutation 50 High VAF, 9 Low VAF • Histologically confirmed HNSCC High VAF= ≥20%, Low VAF = <20% VAF • Treatment failure from most recent prior thera
Slide 5: Patient Demographic and Clinical Characteristics
Patient Demographic and Clinical Characteristics High VAF (N=50) High VAF (N=50) n (%) n (%) Age, yr, median (range) 64 (36 - 90) G12S/G12D/G12V 23 (46) Sex Male/Female 37 (74) /13 (26) G13R/G13V 10 (20) HRAS mutation type White 27 (54) Q61K/Q61R/Q61L 6 (12) Race Asian 20 (40) Other 11 (22) Other 3
Slide 6: Tipifarnib Shows Antitumor Activity and Clinical Benefit
Tipifarnib Shows Antitumor Activity and Clinical Benefit 2L 3L+ Patients with High VAF in mITT (N=50) 1L ORR by IRF: 7/24 ORR by IRF: 3/20 15% [0.03, 0.38] Investigator Independent 29% [0.13, 0.51] Assessment Review Facility Best Overall Response, n (%) Confirmed CR 1 (2) 1 (2) Confirmed PR 14 (28)
Slide 7: Durable Response to Tipifarnib Treatment
Durable Response to Tipifarnib Treatment 1L (N=6) 81 yr Asian female Wide excision June 2020 HRAS G12C, VAF 87% cCRT Jul 2020 to Aug 2020 oral cavity ca 1L Nivo Sept 2020 to Oct 2020 pT2N3bM0, stage IVB 2L Tipi Dec 2020 2L (N=24) Duration of tipifarnib exposure in high VAF patients (N=50): median (r
Slide 8: Safety Conclusions
Safety Conclusions Safety Analysis Set, N=59 • Tipifarnib has clinical efficacy in heavily Grade ≥3 Any Grade pretreated, mHRAS R/M HNSCC n (%) n (%) Patients with Any TRAEs 33 (56) 49 (83) • Tipifarnib is the first targeted therapy for this Anemia 12 (20) 20 (34) rare population with unmet need Neu
Slide 9: Acknowledgements
Acknowledgements The authors would like to thank everyone who made this study possible • Patients, their families and caregivers • Study Investigators and their study teams This study (NCT03719690) was sponsored by Kura Oncology, Inc. Content of this presentation is copyright and responsibility of t