UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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Item 8.01 Other Events.
On April 18, 2023, an abstract providing data as of a January 31, 2023 data cutoff from Kura Oncology, Inc.’s Phase 1/2 clinical trial of ziftomenib in relapsed or refractory acute myeloid leukemia, or KOMET-001, was published on the European Hematology Association’s (“EHA”) website. A copy of the EHA abstract is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | EHA Abstract | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| KURA ONCOLOGY, INC. | ||||||
| Date: April 19, 2023 | By: | /s/ Teresa Bair | ||||
| Teresa Bair | ||||||
| Chief Legal Officer | ||||||
Exhibit 99.1
Background:
The menin and histone-lysine-N-methyltransferase 2A (KMT2A) protein complex is an essential epigenetic regulator of genes critical for maintenance of multiple genetic subtypes of leukemia. This complex is implicated in NPM1 mutant acute myeloid leukemia (AML) (NPM1m, 25-30% of AML) as well as AML with KMT2A gene rearrangements (KMT2Ar; 5-10% of AMLs). The presence of co-mutations in genes such as IDH1/2 and FLT3 portend a poor prognosis, particularly in the relapsed/refractory (R/R) setting. There is high unmet need for the development of agents able to address these patient populations.
Aims:
The purpose of the Phase (Ph) 1 portion of KOMET-001 (NCT04067336) is to establish the safety, tolerability, and recommended phase 2 dose (RP2D) for ziftomenib monotherapy in NPM1-m and KMT2A-r R/R AML.
Methods:
KOMET-001 is a global, open-label Ph 1/2 study of ziftomenib in adult patients (pts) with R/R AML. The dose escalation and randomized, multi-dose expansion in pts with KMT2Ar or NPM1m R/R AML is fully enrolled. The single-arm Ph2 registration-enabling portion evaluating the ziftomenib monotherapy RP2D in pts with R/R NPM1m AML is currently enrolling. Ziftomenib is dosed orally, once daily, in 28-day cycles until relapse, progression, or unacceptable toxicity.
Results:
This report provides updates on the Ph 1 NPM1m pts dosed at the 600mg RP2D (n=20) and on duration of remission (DoR) for a 200mg pt as of 31JAN2023. The median age for pts treated at RP2D was 70.5 years (22 to 86y). FLT3 and IDH1/2 mutations were common (35% FLT3, 30% IDH1/2, and 20% both co-mutations). Median number of prior therapies was 2.5 (r: 1 to 8), including 15% with ≥1 prior stem cell transplant (SCT) and 60% with prior venetoclax.
The cumulative safety profile for the ziftomenib RP2D is consistent with prior reports. Most (85%) had at least one ≥Gr 3 treatment-emergent adverse event (TEAE), with 30% of TEAEs considered potentially treatment-related. The most frequent (>10%) TEAEs ≥ Gr 3 were anemia (25%), pneumonia (20%), thrombocytopenia, neutropenia and hyperglycemia (15% each). Any grade differentiation syndrome (DS) was reported in 20%; 5% (n=1) as Gr 3.
As of 31JAN2023, the complete remission (CR) rate for NPM1m pts treated with 600mg was 30%, composite CR rate (CRc) was 35%, and ORR rate was 40% (see Table 1). The median DoR for pts achieving CRc, which continues to mature, was 8.2 months (m) per Kaplan-Meier estimate (95% CI: 1.5 to NE). One CR was noted at the 200mg dose with an ongoing DoR of 32 cycles. Median time to
CR was 70 days (r: 26 to 89). Two pts (1 CR and 1 CR with incomplete hematologic recovery [CRi]) proceeded to SCT and both remain in remission as of the cutoff. Median overall survival for NPM1m pts treated with 600mg was 5.1m (95% CI: 2.1 to NE), with a median duration of follow-up of 8.0m. At the cutoff, 57.1% of pts achieving CRc at RP2D remain on treatment or in post-SCT follow-up; those on treatment continue to show evidence of evolving responses.
Summary/Conclusion:
Ziftomenib continues to demonstrate significant clinical activity in heavily pretreated and co-mutated R/R NPM1m AML pts. The safety profile remains consistent and the on-target effect of DS continues to be manageable. Data suggest durable remissions as the DoR continues to mature with 5 of 8 pts with CRc ongoing at the cutoff. A single-arm registration-directed Ph 2 study is currently accruing to further evaluate ziftomenib monotherapy in R/R NPM1m AML.
Table 1. Response Rates for NPM1-m Patients treated at the Ziftomenib RP2D
| CR Rate | ||
| n (%) |
6 (30) | |
| 95% (CI) |
(12, 54) | |
| CR/CRH Rate | ||
| n (%) |
6 (30) | |
| 95% (CI) |
(12, 54) | |
| CRc Rate (CR+CRh+CRi) | ||
| n (%) |
7 (35) | |
| 95% (CI) |
(15, 59) | |
| MRD Negativity Rate¹ |
||
| n (%) |
3 (43) | |
| 95% (CI) |
(10, 82) | |
| ORR Rate (CR+CRh+CRI+MLFS) | ||
| n (%) |
8 (40) | |
| 95% (CI) |
(19, 64) | |
| ¹ | Five of 7 patients achieving CRc were evaluated for MRD. Of those evaluated, 60% were MRD negative. |
Document and Entity Information |
Apr. 18, 2023 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001422143 |
| Document Type | 8-K |
| Document Period End Date | Apr. 18, 2023 |
| Entity Registrant Name | KURA ONCOLOGY, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-37620 |
| Entity Tax Identification Number | 61-1547851 |
| Entity Address, Address Line One | 12730 High Bluff Drive |
| Entity Address, Address Line Two | Suite 400 |
| Entity Address, City or Town | San Diego |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 92130 |
| City Area Code | (858) |
| Local Phone Number | 500-8800 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.0001 per share |
| Trading Symbol | KURA |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |