-- Eleven of 13 Enrolled Patients Showed No CNS
Disease Progression on Tesevatinib --
-- Additional Studies Planned, Including
First-Line Study in Patients with Brain and/or Leptomeningeal
Metastases --
Kadmon Holdings, Inc. (NYSE: KDMN) (“Kadmon” or the “Company”)
today announced encouraging data from its ongoing Phase 2 clinical
study of tesevatinib, the Company’s blood-brain barrier penetrant
oral tyrosine kinase inhibitor, for the treatment of epidermal
growth factor receptor (EGFR) mutation-positive non-small cell lung
cancer (NSCLC) that has metastasized to the brain and/or the
leptomeninges (membranes lining the brain and spinal cord). The
data were presented today in a poster session at the International
Association for the Study of Lung Cancer 17th World Conference on
Lung Cancer in Vienna, Austria.
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A patient with EGFR mutation-positive
NSCLC with brain metastases and with no prior treatment (left)
showed a partial response in the brain in an MRI taken after 29
days of tesevatinib therapy (right) and showed a partial response
in both brain metastases and peripheral disease after 57 days of
tesevatinib therapy (Photo: Business Wire)
Eleven of the first 13 enrolled patients treated with
tesevatinib 300 mg QD in this ongoing study did not have central
nervous system (CNS) progression on tesevatinib. Eight of these
patients showed an improvement in clinical symptoms, often by Day
14 of treatment. Intracranial radiological improvement was
documented in four patients who had follow-up MRIs.
The study is being conducted in patients who have progressed
with brain metastases and/or symptomatic leptomeningeal metastases
while on prior therapy with other EGFR inhibitors, as well as in
patients with no prior treatment and brain metastases at initial
presentation. Of the 13 enrolled patients, 12 had disease
progression while on prior treatment with the EGFR inhibitor
erlotinib and radiation therapy to the brain, five of whom had also
received other EGFR inhibitors and chemotherapy. Currently approved
EGFR inhibitors have poor brain penetration, limiting their ability
to treat intracranial metastases. The rapid action of tesevatinib
on clinical symptoms and shrinkage of tumor volumes demonstrates
conclusively that tesevatinib enters the CNS and targets
EGFR-driven tumors.
The study was designed specifically to assess the efficacy of
tesevatinib in CNS metastases, with full knowledge that these
heavily pretreated patients had extensive exposure to other EGFR
inhibitors and that tesevatinib therefore may not control
peripheral disease well due to the previous development of EGFR
inhibitor resistance mechanisms. Thus, as expected, five of the 12
pretreated patients had peripheral disease progression, while in
four of those five patients, tesevatinib controlled CNS
lesions.
In addition to the results observed in pretreated patients, one
enrolled patient with no prior treatment who presented with brain
metastases showed a robust partial response in brain metastases in
an MRI taken on Study Day 29 and showed a partial response in both
brain metastases and peripheral disease at Study Day 57. This
patient continues on tesevatinib as of Study Day 92. These findings
support the notion that tesevatinib monotherapy has the potential
to be a first-line treatment in this patient population.
Based on these interim results, Kadmon plans to initiate a
randomized, first-line study of tesevatinib monotherapy in patients
with EGFR-mutant NSCLC who present with CNS metastases. In
addition, Kadmon will enroll a randomized study of tesevatinib in
patients with leptomeningeal metastases who have progressed while
on currently approved EGFR inhibitor therapies.
“Unlike other EGFR inhibitors, tesevatinib penetrates the
blood-brain barrier to reach metastases in the central nervous
system, a sanctuary site for EGFR-driven cancers,” said David Berz,
M.D., Ph.D., MPH, clinical oncologist at Beverly Hills Cancer
Center and a principal investigator of the study. “These results
indicate that tesevatinib has major therapeutic potential for CNS
metastases in the first-line setting as well as in heavily
pretreated patients.”
“The dramatic responses observed in a high proportion of these
NSCLC patients with intracranial metastases, particularly in
difficult-to-treat individuals, support our continued development
of tesevatinib for the treatment of metastatic NSCLC,” said Harlan
W. Waksal, M.D., President and Chief Executive Officer at Kadmon.
“Based on these encouraging initial results, we believe that
tesevatinib as first-line therapy may treat existing CNS metastases
as well as potentially prevent the development of new lesions.”
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company focused on developing innovative products for significant
unmet medical needs. We have a diversified product pipeline in
oncology, autoimmune and fibrotic diseases and genetic
diseases.
Safe Harbor Statement
This press release contains forward-looking statements. Such
statements may be preceded by the words “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “could,” “intends,” “targets,”
“projects,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other
similar expressions. Forward-looking statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. We believe that these factors include, but are not
limited to, (i) the initiation, timing, progress and results of our
preclinical studies and clinical trials, and our research and
development programs; (ii) our ability to advance product
candidates into, and successfully complete, clinical trials; (iii)
our reliance on the success of our product candidates; (iv) the
timing or likelihood of regulatory filings and approvals; (v) our
ability to expand our sales and marketing capabilities; (vi) the
commercialization of our product candidates, if approved; (vii) the
pricing and reimbursement of our product candidates, if approved;
(viii) the implementation of our business model, strategic plans
for our business, product candidates and technology; (ix) the scope
of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and
technology; (x) our ability to operate our business without
infringing the intellectual property rights and proprietary
technology of third parties; (xi) costs associated with defending
intellectual property infringement, product liability and other
claims; (xii) regulatory developments in the United States, Europe
and other jurisdictions; (xiii) estimates of our expenses, future
revenues, capital requirements and our needs for additional
financing; (xiv) the potential benefits of strategic collaboration
agreements and our ability to enter into strategic arrangements;
(xv) our ability to maintain and establish collaborations or obtain
additional grant funding; (xvi) the rate and degree of market
acceptance of our product candidates; (xvii) developments relating
to our competitors and our industry, including competing therapies;
(xviii) our ability to effectively manage our anticipated growth;
(xix) our ability to attract and retain qualified employees and key
personnel; and (xx) our ability to achieve cost savings and other
benefits from our efforts to streamline our operations and to not
harm our business with such efforts. More detailed information
about Kadmon and the risk factors that may affect the realization
of forward-looking statements is set forth in the Company's filings
with the U.S. Securities and Exchange Commission (SEC), including
the Company's Quarterly Report on Form 10-Q filed pursuant to
Section 13 of the Securities Exchange Act of 1934, as amended, with
the SEC on November 9, 2016. Investors and security holders are
urged to read these documents free of charge on the SEC's web site
at www.sec.gov. The Company assumes no obligation to publicly
update or revise its forward-looking statements as a result of new
information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20161206005353/en/
Kadmon Holdings, Inc.Investor RelationsEllen Tremaine,
646-490-2989ellen.tremaine@kadmon.comorMaeve Conneighton,
212-600-1902maeve@argotpartners.com
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