Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, today announced
results from its registration-directed AIM-HN study of tipifarnib
in patients with HRAS mutant head and neck squamous cell carcinoma
(HNSCC) whose disease is recurrent or metastatic and has progressed
after prior therapy.
These clinical results are being featured during
a late-breaking oral session at the 2023 European Society for
Medical Oncology (ESMO) Congress in Madrid, Spain, in a
presentation titled, “A phase 2 study evaluating tipifarnib in
mHRAS, recurrent or metastatic (R/M) head and neck squamous cell
carcinoma (HNSCC) (AIM-HN study).” The abstract is now available on
the ESMO website and the presentation will be available in the
Posters and Presentations section on Kura’s website at the start of
the poster session on Saturday, October 21, 2023 at 10:15AM
CEST.
As of the data cutoff on June 15, 2023, 59
patients with R/M HRAS mutant HNSCC were enrolled, of whom 50 had
high HRAS mutant variant allele frequency (VAF)1 and 38 were
evaluable for efficacy. The following table compares response
assessed between the investigators and the independent review
facility (IRF), in the modified intent to treat (mITT) high VAF
population2.
|
Investigator Assessment (n=50) |
Independent Review Facility
(n=50) |
Best Overall Response, n (%) |
|
|
Confirmed Complete Response (CR) |
1 (2) |
1 (2) |
Confirmed Partial Response (PR) |
14 (28) |
9 (18) |
Stable Disease (SD) |
17 (34) |
14 (28) |
Progressive Disease (PD) |
6 (12) |
14 (28) |
Not Evaluable (NE) |
12 (24) |
12 (24) |
ORR, n (%) [95% CI] |
15 (30) [0.18, 0.45] |
10 (20) [0.10, 0.34] |
mDoR, months [95% CI] |
5.6 [3.88, 9.23] |
6.5 [3.88, -] |
mPFS, months [95% CI] |
3.7 [2.60, 5.55] |
2.6 [1.87, 4.40] |
*ORR, objective response rate; -, not
calculable; mDoR, median duration of response; mPFS, median
progression free survival; CI, confidence interval.
Both assessments by investigators and IRF
observed one patient achieving a CR on treatment. Patients had a
median of two prior lines of therapy (range 0-6) in the
recurrent/metastatic setting and robust activity was seen in second
line treatment and beyond with greater activity observed in the
second line versus the third line and subsequent treatments. The
ORR in second line treatment was 29% [0.13, 0.51] in the IRF
assessment. The ORR for three FDA-approved therapies for the
treatment of HNSCC in the second line range from 13-16%.
“The results from the AIM-HN study are
encouraging as they demonstrate meaningful clinical benefit of
tipifarnib in a subset of HNSCC for which there are currently no
other targeted therapies in development, and a significant unmet
need exists for the population,” said Alan Ho, M.D., Ph.D., of
Memorial Sloan Kettering Cancer Center and principal investigator
of the study. “We are grateful to the patients and their families
for their trial participation and for the scientific community who
have contributed to this pivotal research in an effort to impact
patients’ lives.”
Patients in the AIM-HN trial received tipifarnib
at a dose of 600 mg orally twice daily on days 1-7 and 15-21 of
28-day cycles. Tipifarnib was generally well-tolerated with a
manageable safety profile. The most common grade 3 or 4
treatment-related adverse events (TRAEs) seen in at least 10% of
patients were cytopenias and TRAEs led to discontinuation of
treatment in 7% of patients.
“We continue to be encouraged by the compelling
safety profile and activity of tipifarnib as a monotherapy in this
difficult-to-treat population of advanced head and neck cancer,
supported by our Breakthrough Therapy Designation from the FDA,”
said Troy Wilson, Ph.D., J.D., President and Chief Executive
Officer of Kura Oncology. “Building on the results of the previous
RUN-HN study, these data confirm that, in the proper biological
context in which a target protein is obligately farnesylated, FTIs
have potential to drive meaningful clinical benefit for patients.
With these data in hand, we continue to evaluate in the ongoing
KURRENT-HN study whether the combination of tipifarnib and
alpelisib has potential to extend the clinical benefit observed in
this study to a broader set of HNSCC patients.”
“In addition,” Dr. Wilson continued, “we believe
these positive results from AIM-HN validate the therapeutic value
of farnesyl transferase inhibition as we begin to execute on our
clinical development plan for our next-generation FTI, KO-2806,
which we will use to target other farnesylated targets such as RHEB
and which we believe could become the preferred combination partner
for a number of targeted therapies in multiple large solid tumor
indications, including KRAS inhibitors in certain solid tumors and
tyrosine kinase inhibitors in clear cell renal cell carcinoma.”
About AIM-HN
AIM-HN is a multicenter, open-label, pivotal
study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC.
Eligibility criteria include patients with recurrent or metastatic
HRAS mutant HNSCC at any VAF level. The primary and key secondary
endpoints of this trial include ORR and DoR in the high VAF
population. The trial was designed to enroll at least 59 patients
with HRAS mutant HNSCC who received prior platinum-based therapy
and was closed to enrollment in November 2022. Further details
regarding the trial are available at clinicaltrials.gov
(NCT03719690).
About HNSCC
Head and neck squamous cell carcinoma (HNSCC) is
the seventh most common cancer worldwide, accounting for more than
500,000 new cases each year. Despite advances in immunotherapy, the
prognosis for advanced HNSCC patients remains poor, with an
estimated median overall survival of 13-15 months in patients when
stratified by PD-L1 expression. Although the anti-epidermal growth
factor receptor (EGFR) antibody, cetuximab, was approved more than
a decade ago, development of biomarker-directed therapies in HNSCC
has been stymied by the limited number of druggable targets in the
genomic landscape and the challenge of managing drug refractory,
recurrent/metastatic HNSCC.
About Kura Oncology
Kura Oncology is a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer. The Company’s
pipeline consists of small molecule drug candidates that target
cancer signaling pathways. Ziftomenib is a once-daily, oral drug
candidate targeting the menin-KMT2A protein-protein interaction for
the treatment of genetically defined acute myeloid leukemia (AML)
patients with high unmet need. Kura is currently enrolling patients
in a Phase 2 registration-directed trial of ziftomenib in
NPM1-mutant relapsed or refractory AML (KOMET-001). The Company is
also conducting a series of studies to evaluate ziftomenib in
combination with current standards of care, beginning with
venetoclax/azacitidine and standard induction
cytarabine/daunorubicin chemotherapy in NPM1-mutant and
KMT2A-rearranged newly diagnosed and relapsed/refractory AML
(KOMET-007). Tipifarnib, a potent and selective FTI, is currently
in a Phase 1/2 trial in combination with alpelisib for patients
with PIK3CA-dependent head and neck squamous cell carcinoma
(KURRENT-HN). Kura is also preparing to evaluate KO-2806, a
next-generation FTI, in a Phase 1 dose-escalation trial as a
monotherapy and in combination with other targeted therapies,
beginning with ccRCC and KRASG12C-mutant NSCLC (FIT-001). For
additional information, please visit Kura’s website at
www.kuraoncology.com and follow us on Twitter and LinkedIn.
Disclosures
Memorial Sloan Kettering (MSK) has institutional
financial interests related to Kura Oncology. Dr. Ho has financial
interests related to Kura Oncology.
Forward-Looking Statements
This news release contains certain
forward-looking statements that involve risks and uncertainties
that could cause actual results to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. Such forward-looking statements
include statements regarding, among other things, the efficacy,
safety and therapeutic potential of tipifarnib, potential benefits
of combining tipifarnib with appropriate standards of care, and
progress and expected timing of the tipifarnib program and clinical
trials. Factors that may cause actual results to differ materially
include the risk that compounds that appeared promising in early
research or clinical trials do not demonstrate safety and/or
efficacy in later preclinical studies or clinical trials, the risk
that Kura may not obtain approval to market its product candidates,
uncertainties associated with performing clinical trials,
regulatory filings, applications and other interactions with
regulatory bodies, risks associated with reliance on third parties
to successfully conduct clinical trials, the risks associated with
reliance on outside financing to meet capital requirements, and
other risks associated with the process of discovering, developing
and commercializing drugs that are safe and effective for use as
human therapeutics, and in the endeavor of building a business
around such drugs. You are urged to consider statements that
include the words “may,” “will,” “would,” “could,” “should,”
“believes,” “estimates,” “projects,” “promise,” “potential,”
“expects,” “plans,” “anticipates,” “intends,” “continues,”
“designed,” “goal,” or the negative of those words or other
comparable words to be uncertain and forward-looking. For a further
list and description of the risks and uncertainties the Company
faces, please refer to the Company's periodic and other filings
with the Securities and Exchange Commission (SEC), including the
Company’s Form 10-Q for the quarter ended June 30, 2023 filed with
the SEC on August 9, 2023, which are available at www.sec.gov. Such
forward-looking statements are current only as of the date they are
made, and Kura assumes no obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts
Investors:Pete De SpainExecutive Vice President, Investor
Relations &Corporate Communications(858)
500-8833pete@kuraoncology.com
Media:Alexandra WeingartenSenior Manager, Corporate
Communications(858) 500-8822 alexandra@kuraoncology.com
1 HRAS variant allele frequency ≥ 20% and treated with at least
one dose of tipifarnib2 One low VAF patient (< 20% VAF) was a
responder to treatment
Kura Oncology (NASDAQ:KURA)
Historical Stock Chart
From Apr 2024 to May 2024
Kura Oncology (NASDAQ:KURA)
Historical Stock Chart
From May 2023 to May 2024