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
updated clinical outcome data from its RUN-HN study, a Phase 2
open-label, single-arm trial of tipifarnib in patients with HRAS
mutant head and neck squamous cell carcinoma (HNSCC) whose disease
had progressed after prior therapy. These data are being presented
in an oral session at the American Society of Clinical Oncology
(ASCO) Virtual Scientific Program, being held May 29-31, 2020. A
copy of the presentation is available on Kura's website at
www.kuraoncology.com/pipeline/publications.
At data cutoff, 21 patients with HRAS mutant HNSCC were
enrolled1, of whom 18 were evaluable for efficacy. Nine of the 18
evaluable patients achieved a confirmed partial response (PR), for
an objective response rate (ORR) of 50% (95% CI, 26.0 to 74.0),
with a median duration of response of 14.7 months. Median
progression-free survival (PFS) was 5.9 months (95% CI, 3.5 to
19.2), compared to 2.8 months on the patients’ last prior therapy.
Median overall survival (OS) was 15.4 months (95% CI, 7.0 to 46.4).
Patients had a median of two prior lines of therapy (range 0-6).
Robust activity was seen despite resistance to chemotherapy,
immunotherapy and/or cetuximab.
ORR for three FDA-approved therapies for treatment of HNSCC in
the second line range from 13-16%, with median PFS of 2-3 months
and median OS of 5-8 months.
“It’s encouraging to see robust overall survival data for
tipifarnib, which demonstrate a potentially meaningful development
for HNSCC patients with HRAS mutations in the advanced setting,”
said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer
Center and principal investigator of the study. “These data add to
the body of evidence emerging for tipifarnib in second line HNSCC
patients, a patient population with very few treatment options and
a high unmet need. These results also highlight the importance of
tumor genomic profiling to identify patients with HRAS mutations
who could potentially be suitable for tipifarnib treatment.”
Patients in the RUN-HN trial received tipifarnib at a starting
dose of 600 or 900 mg orally twice daily on days 1-7 and 15-21 of
28-day cycles. Tipifarnib was generally well-tolerated. The most
common grade 3 or 4 adverse events (AEs) seen in at least 10% of
patients were cytopenias and GI disturbances.
“We believe a median overall survival of 15 months is
unprecedented in this patient population and represents a
substantial improvement compared to historical benchmarks with
current standard of care,” said Troy Wilson, Ph.D., J.D., President
and Chief Executive Officer of Kura Oncology. “Taken together,
these data support our enhanced focus on patients with HRAS mutant
HNSCC, a population in desperate need of effective new treatments,
and reinforce our confidence in the ongoing AIM-HN
registration-directed trial.”
The AIM-HN registration-directed trial of tipifarnib in patients
with recurrent or metastatic HRAS mutant HNSCC is currently
recruiting at approximately 90 clinical sites in the U.S., Europe
and Asia. Patients interested in participating in this trial may
talk to their doctor to have their tumor tested for the HRAS
mutation for eligibility to enroll in this trial. Further details
regarding the trial are available at clinicaltrials.gov
(NCT03719690).
Activity in HRAS Mutant Salivary Gland Cancer and
Urothelial Carcinoma
In addition to updated clinical outcome data in patients with
HRAS mutant HNSCC, Kura also reported compelling single-agent
activity in tumors of the salivary gland and urothelial carcinoma
with HRAS mutations.
Seven recurrent/metastatic salivary gland cancer patients were
enrolled in the all “other” HRAS mutant squamous cell carcinoma
cohort in the Phase 2 tipifarnib trial and six additional patients
were treated off-protocol through an expanded access program, of
whom a total of 12 were evaluable for efficacy. One patient
achieved a confirmed PR and seven achieved disease stabilization.
Median PFS was 7.0 months (95% CI, 5.9 to 10.1) and median OS was
18.0 months (95% CI, 9.6 to 22.4). Adverse events observed were
consistent with the known safety profile of tipifarnib. Salivary
gland cancer is a rare disease for which standard treatments do not
exist. Sequencing efforts in salivary gland cancers have identified
HRAS mutations in up to 20% of high-grade histologic
subtypes2,3.
In addition, 21 patients with metastatic urothelial carcinoma
were treated in an investigator-sponsored trial conducted at the
Samsung Medical Center in Seoul, South Korea, including 14 patients
with HRAS missense mutations, one patient with an HRAS nonsense
mutation and six patients with a polymorphism in the STK11 gene. A
confirmed ORR of 24% (95% CI, 6 to 42) was achieved, with all five
responses seen in patients with HRAS mutations. Median PFS was 4.7
months (95% CI, 2.5 to 5.6) and median OS was 6.1 months (95% CI,
5.0 to 7.2). The most frequently observed AEs in the study were
consistent with the known safety profile of tipifarnib.
Approximately 6% of urothelial carcinoma patients are estimated to
carry an HRAS mutation4.
Disclosures
Memorial Sloan Kettering (MSK) has institutional financial
interests related to the research in this release in the form of
intellectual property rights and associated interests by virtue of
licensing agreements between MSK and Kura.
About HNSCC
Head and neck squamous cell carcinoma (HNSCC) accounts for more
than 885,000 new cancer cases each year worldwide with many cancers
arising due to tobacco and/or alcohol use or human papilloma virus
(HPV) infection. Despite advances in immunotherapy, the prognosis
for advanced HNSCC patients remains poor with an estimated median
overall survival (OS) of 13-15 months in patients when stratified
by PD-L1 expression. Although the anti-epidermal growth factor
(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 Tipifarnib
Tipifarnib, is a potent, selective and orally bioavailable
inhibitor of farnesyl transferase in-licensed from Janssen in
December 2014. Previously, tipifarnib was studied in more than
5,000 cancer patients and showed compelling and durable anti-cancer
activity in certain patient subsets; however, no molecular
mechanism of action had been determined that could explain its
clinical activity across a range of solid tumor and hematologic
indications. Leveraging advances in next generation sequencing as
well as emerging information about cancer genetics and tumor
biology, the Company is seeking to identify those patients most
likely to benefit from tipifarnib. Tipifarnib has been granted Fast
Track designation by the U.S. Food and Drug Administration for the
treatment of patients with HRAS mutant HNSCC. Kura has received
multiple issued patents for tipifarnib, providing patent
exclusivity in the U.S. and foreign countries.
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 two wholly
owned small molecule drug candidates that target cancer signaling
pathways where there is a strong scientific and clinical rationale
to improve outcomes by identifying those patients most likely to
benefit from treatment. Kura’s most advanced drug candidate is
tipifarnib, a potent, selective and orally bioavailable farnesyl
transferase inhibitor currently in a registration-directed trial in
patients with recurrent or metastatic HRAS mutant HNSCC. The
Company’s pipeline is also highlighted by KO-539, a potent and
selective inhibitor of the menin-KMT2A(MLL) protein-protein
interaction currently in a Phase 1/2A clinical trial in patients
with relapsed/refractory acute myeloid leukemia. For additional
information about Kura, please visit the Company’s website at
www.kuraoncology.com.
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 Kura’s product candidate tipifarnib. 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 Oncology
may not obtain approval to market its product candidates,
uncertainties associated with performing clinical trials,
regulatory filings and applications, risks associated with reliance
on third parties to successfully conduct clinical trials, the risks
associated with reliance on outside financing to meet capital
requirements, the risks associated with the COVID-19 global
pandemic, 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,” “confidence,” “expects,” “plans,” “anticipated,”
“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, which are available at www.sec.gov. Such
forward-looking statements are current only as of the date they are
made, and Kura Oncology assumes no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts
Company:Pete De SpainVice President, Investor Relations
&Corporate Communications(858)
500-8803pete@kuraoncology.com
Investors:Robert H. UhlManaging DirectorWestwicke ICR(858)
356-5932robert.uhl@westwicke.com
Media:Jason SparkManaging DirectorCanale Communications(619)
849-6005jason@canalecomm.com
1 Patients with HRAS variant allele frequency >35%, or ≥
20% if serum albumin ≥ 3.5 g/dL, including one patient who was
treated off-protocol through an expanded access program2 Ross JS,
et al. Ann Oncol. 2017;28(10):2539-25463 Kato S, et al. Oncotarget.
2015;6(28):25631-256454 Der CJ. Are All RAS Proteins Created Equal
in Cancer? National Cancer Institute, 2017
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