- Entrectinib demonstrated a 78 percent
(25 out of 32; by Investigator) and 69 percent (22 out of 32; by
BICR) confirmed objective response rate (ORR) based on an interim
analysis of patients with ROS1 fusion-positive advanced non-small
cell lung cancer
- Entrectinib showed a median duration of
response of 28.6 months and median progression free survival of
29.6 months, with 53 percent of patients remaining on study
- Compelling central nervous system (CNS)
activity observed, with an 83 percent (5 out of 6; by BICR)
confirmed intracranial ORR in patients with measurable CNS
metastases at presentation
- Entrectinib was well tolerated, with
more than 200 patients treated at the recommended phase 2 dose,
with mostly Grade 1-2 reversible treatment-related adverse
events
- Company to host conference call and
webcast on October 18 at 8:00 a.m. Eastern Time
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology
company focused on precision medicine in oncology, today announced
updated results from its clinical trials, including the STARTRK-2
trial, of entrectinib - an investigational, CNS-active, potent, and
selective tyrosine kinase inhibitor being developed for tumors that
harbor NTRK fusions or ROS1 fusions. In this interim
analysis, entrectinib demonstrated a 78% confirmed ORR (by
Investigator; 95% CI: 60.0, 90.7) and a 69% confirmed ORR (by
Blinded Independent Central Review, or BICR; 95% CI: 50.0, 83.9) in
32 patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) that harbored ROS1 fusions. Entrectinib demonstrated
compelling durability in these patients, with a median duration of
response (mDOR) of 28.6 months (by BICR; 95% CI: 6.8, 34.8; median
follow-up of 12.9 months) and a median progression free survival
(mPFS) of 29.6 months (by BICR; 95% CI: 7.7, 36.6; median follow-up
of 8.5 months). Of the patients evaluated, 11 had CNS metastases at
baseline as assessed by Investigator, and 83 percent (5 out of 6;
by BICR) of the patients with measurable CNS metastases at
presentation had confirmed intracranial RECIST responses to
treatment with entrectinib. The data were presented today in an
oral presentation at the International Association for the Study of
Lung Cancer (IASLC) 18th World Conference on Lung
Cancer (WCLC) in Yokohama, Japan.
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"Based on these data, we believe that entrectinib has the
potential to be a best-in-class therapeutic option as a first-line
targeted therapy for patients with ROS1-positive NSCLC,” said
Jonathan Lim, M.D., chairman and CEO of Ignyta. “The extended
duration of response and progression free survival times observed
in these interim data are particularly compelling, and we believe
may be driven by entrectinib’s CNS activity. Entrectinib was
designed to cross the blood-brain barrier, allowing it to both
address preexisting CNS lesions and have the potential to prevent
or delay the onset of metastases to the brain, a common site of
progression, particularly in NSCLC.”
Safety was consistent with previous studies of entrectinib. With
over 200 patients treated at the recommended phase 2 dose, most
adverse events (AEs) were Grade 1-2 and reversible, and only 3
percent of patients discontinued from the study due to
treatment-related AEs (TRAEs). The most common TRAEs were dysgeusia
(38%), fatigue (29%), constipation (23%), dizziness (23%), and
increased weight (19%). The most common Grade 3 TRAEs were
increased weight (5%), anemia (4%), and fatigue (3%). There were no
Grade 4 events occurring in greater than one percent of patients
and no Grade 5 TRAEs.
“ROS1 fusions occur in approximately two percent of all cases of
NSCLC and, given the propensity for these tumors to metastasize to
the brain, the CNS activity of entrectinib is a critical
differentiating feature of the compound and may be contributing to
the impressive duration and progression free survival it has
demonstrated thus far,” said Myung-Ju Ahn, Professor in the
Department of Hematology and Oncology at the Samsung Medical Center
in Seoul Korea and study author.
In addition to these data in ROS1-positive NSCLC, entrectinib
has demonstrated promising preliminary antitumor activity across
NTRK-positive solid tumors, an indication for which entrectinib has
received breakthrough therapy designation (BTD) from the U.S. Food
and Drug Administration (FDA) and PRIME designation from the
European Medicines Agency (EMA). Based on recent guidance from the
FDA, the company is on track for dual NDA submissions in both the
NTRK tissue-agnostic and the ROS1-positive NSCLC indications in
2018.
A conference call and live webcast will be held on October
18, 2017, at 8:00 a.m. Eastern Time to discuss the data
presented, as well as the comprehensive entrectinib program. To
participate in the conference call, please dial 800-946-0716 (U.S.)
or 719-325-4934 (international) and provide Conference ID 7994148.
To access the live webcast, go
to https://www.ignyta.com/investors/.
About Entrectinib
Entrectinib is an investigational, CNS-active, potent, and
selective small molecule tyrosine kinase inhibitor of the TRK
(tropomyosin receptor kinase) family of tyrosine kinase receptors
(TRKA, TRKB and TRKC) and ROS1 proteins, which is in a Phase 2
clinical study and two Phase 1 clinical studies in molecularly
defined adult patient populations for the treatment of solid
tumors, and a Phase 1/1b clinical study in pediatric patients with
advanced solid tumor malignancies.
About STARTRK-2
STARTRK-2 is an open-label, multicenter, global Phase 2 basket
study of entrectinib for the treatment of patients with locally
advanced or metastatic solid tumors that harbor NTRK1/2/3, ROS1, or
ALK gene rearrangements. The basket design screens patient tumor
samples for the relevant targets to take full advantage of
entrectinib’s demonstrated preliminary clinical activity across a
range of different tumor types and molecular targets.
About Ignyta, Inc.
Blazing a New Future for Patients with
Cancer™
At Ignyta, we work tirelessly on behalf of patients with
cancer to offer potentially life-saving, precisely targeted
therapeutics (Rx) guided by diagnostic (Dx) tests. Our integrated
Rx/Dx strategy allows us to enter uncharted territory, illuminating
the molecular and immunological drivers of cancer and quickly
advancing treatments to address them. This approach embraces even
those patients with rare cancers, who have the highest unmet need
and who may otherwise not have access to effective treatment
options. With our pipeline of potentially first-in-class or
best-in-class precision medicines, we are pursuing the ultimate
goal of not just shrinking tumors, but eradicating cancer relapse
and recurrence in precisely defined patient populations.
For more information, please visit: www.ignyta.com.
About the WCLC
The World Conference on Lung Cancer (WCLC) is the world’s
largest meeting dedicated to lung cancer and other thoracic
malignancies, attracting over 6,000 researchers, physicians and
specialists from more than 100 countries. The goal is to
disseminate the latest scientific achievements; increase awareness,
collaboration and understanding of lung cancer; and to help
participants implement the latest developments across the globe.
Organized under the theme of "Synergy to Conquer Lung Cancer," the
conference will cover a wide range of disciplines and unveil
several research studies and clinical trial results. For more
information, visit http://wclc2017.iaslc.org/.
Forward-Looking Statements
This press release contains forward-looking statements
about Ignyta as that term is defined in Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements in this press release that are not
purely historical are forward-looking statements. Such
forward-looking statements include, among other things: references
to the development of and path to potential regulatory approval of
entrectinib and our other product candidates, including potential
differentiating factors; the clinical and/or non-clinical data or
plans underlying entrectinib or any of our other development
programs, the potential for entrectinib to be a best-in-class
therapeutic, and the corporate milestones and timelines associated
with such programs; our ability to design and conduct development
activities for entrectinib and our other development programs; our
ability to obtain regulatory approvals in order to market any of
our product candidates; and our ability to successfully
commercialize any approved products. Actual results could differ
from those projected in any forward-looking statements due to
numerous factors. Such factors include, among others, the inherent
uncertainties associated with developing new products or
technologies and operating as a development stage
company; Ignyta’s ability to develop, initiate or
complete preclinical studies and clinical trials for, obtain
approvals for and commercialize any of its product candidates;
changes in Ignyta’s plans to develop and commercialize
its product candidates; the potential for final results of the
ongoing clinical trials of entrectinib or other product candidates,
or any future clinical trials of entrectinib or other product
candidates, to differ from preliminary or expected
results; Ignyta’s ability to raise any additional funding
it will need to continue to pursue its business and product
development plans; regulatory developments in the United
States and foreign countries; our dependence on third party
manufacturers for supply of our product candidates and any approved
products; Ignyta’s ability to obtain and maintain
intellectual property protection for its product candidates; the
risk that orphan drug exclusivity may not effectively protect a
product from competition and that such exclusivity may not be
maintained; the potential for the company to fail to maintain the
CAP accreditation and CLIA certification of its diagnostic
laboratory; the loss of key scientific or management personnel;
competition in the industry in which Ignyta operates; and
market conditions. These forward-looking statements are made as of
the date of this press release, and Ignyta assumes no
obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those projected in
the forward-looking statements. Investors should consult all of the
information set forth herein and should also refer to the risk
factor disclosure set forth in the reports and other documents the
company files with the SEC available at www.sec.gov,
including without limitation Ignyta’s Annual Report on
Form 10-K for the year ended December 31, 2016 and
subsequent Quarterly Reports on Form 10-Q.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171017006907/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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