Loxo Oncology Announces Completion of Clinical Trial Enrollment for Larotrectinib NDA Primary Efficacy Analysis
February 21 2017 - 6:45AM
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today announced that the
company has completed clinical trial enrollment for the
larotrectinib New Drug Application (NDA) primary efficacy analysis.
This determination is based on written feedback from the U.S. Food
and Drug Administration (FDA), which affirmed the target enrollment
goal for the primary efficacy analysis data set to support an NDA
filing.
All larotrectinib clinical trials will remain
open to provide a mechanism for drug access to newly identified
patients during forthcoming regulatory interactions and
review.
The primary efficacy analysis for larotrectinib will be based on
RECIST v1.1 overall response rate (ORR), as determined by
independent radiology review, for NTRK fusion patients enrolled
across the three ongoing larotrectinib clinical studies. Durability
of response and safety are also critical elements of the regulatory
risk-benefit determination. The company expects to report top-line
data for the NDA dataset in the second half of 2017, and expects to
submit a New Drug Application in late 2017 or early 2018, and a
European Marketing Authorisation Application (MAA) in 2018.
Loxo Oncology intends to submit for approval for the same
indication statement upon which the FDA granted Breakthrough
Therapy Designation for larotrectinib, “for the treatment of
unresectable or metastatic solid tumors with NTRK-fusion proteins
in adult and pediatric patients who require systemic therapy and
who have either progressed following prior treatment or who have no
acceptable alternative treatments.”
About Larotrectinib (LOXO-101)Larotrectinib
(LOXO-101) is a potent, oral and selective investigational new drug
in clinical development for the treatment of patients with cancers
that harbor abnormalities involving the tropomyosin receptor
kinases (TRKs). Growing research suggests that the NTRK genes,
which encode for TRKs, can become abnormally fused to other genes,
resulting in growth signals that can lead to cancer in many sites
of the body. In an ongoing Phase 1 clinical trial, larotrectinib
has demonstrated encouraging preliminary efficacy. Larotrectinib is
also being evaluated in the NAVIGATE global Phase 2 multi-center
basket trial in patients with solid tumors that harbor TRK gene
fusions, and the SCOUT Phase 1/2 trial in pediatric patients,
including patients with advanced cancer, TRK gene fusions and
infantile fibrosarcoma. Larotrectinib has been granted Breakthrough
Therapy Designation and Rare Pediatric Disease Designation by the
U.S. FDA. For additional information about the larotrectinib
clinical trials, please refer to www.clinicaltrials.gov. Interested
patients and physicians can contact the Loxo Oncology Physician and
Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit
www.loxooncologytrials.com.
About Loxo OncologyLoxo Oncology is a
biopharmaceutical company innovating the development of highly
selective medicines for patients with genetically defined cancers.
Our pipeline focuses on cancers that are uniquely dependent on
single gene abnormalities, such that a single drug has the
potential to treat the cancer with dramatic effect. We believe that
the most selective, purpose-built medicines have the highest
probability of maximally inhibiting the intended target, thereby
delivering best-in-class disease control and safety. Our management
team seeks out experienced industry partners, world-class
scientific advisors and innovative clinical-regulatory approaches
to deliver new cancer therapies to patients as quickly and
efficiently as possible. For more information, please visit the
company's website at www.loxooncology.com.
Forward Looking StatementsThis press release
contains "forward-looking" statements within the meaning of the
safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
words such as: "anticipate," "intend," "plan," "goal," "seek,"
"believe," "project," "estimate," "expect," "strategy," "future,"
"likely," "may," "should," "will" and similar references to future
periods. These statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from what we expect. Examples of forward-looking statements
include, among others, statements we make regarding the timing and
success of our clinical trials or regulatory approvals and timing
of future filings. Further information on potential risk factors
that could affect our business and its financial results are
detailed in our most recent Quarterly Report on Form 10-Q, and
other reports as filed from time to time with the Securities and
Exchange Commission. We undertake no obligation to publicly update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contacts for Loxo Oncology, Inc.
Company: Jacob S. Van Naarden Chief Business
Officerjake@loxooncology.com
Investors:Peter Rahmer The Trout Group, LLC 646-378-2973
prahmer@troutgroup.com
Media:Dan Budwick Pure Communications, Inc. 973-271-6085
dan@purecommunicationsinc.com
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