– 75% Overall Response Rate by Independent
Review; 80% Overall Response Rate by Investigator Assessment –
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today announced top-line
overall response rate (ORR) results from the independent review
committee assessment of the larotrectinib dataset. The full dataset
is being reserved for a future publication. Consistent with prior
guidance, Loxo Oncology expects to submit a New Drug Application
(NDA) for evaluation by the U.S. Food and Drug Administration (FDA)
in late 2017 or early 2018, and a Marketing Authorisation
Application (MAA) for evaluation by the European Medicines Agency
(EMA) in 2018.
“Today’s results have exceeded our expectations, and confirm the
depth and breadth of response larotrectinib delivers to patients
with TRK fusion cancers,” said Josh Bilenker, M.D., chief executive
officer of Loxo Oncology. “We are indebted to our investigators and
team members, whose care and sophistication in the execution of the
larotrectinib clinical development program have now been validated
by independent review.”
The following table compares response determinations between the
independent review committee and investigators, using a July 17,
2017 data cut-off date:
|
Independent Review Committee Assessed Response
(n=55) |
Investigator Assessed
Response(n=55) |
Overall Response Rate (ORR = PR+CR) |
75%(95% CI: 61% – 85%) |
80%*(95% CI: 67% – 90%) |
Partial Response (PR) |
62 |
% |
64%* |
Complete Response (CR) |
13 |
% |
16 |
% |
Stable Disease |
13 |
% |
9 |
% |
Progressive Disease |
9 |
% |
11 |
% |
Not Evaluable |
4 |
% |
0 |
% |
* Includes one unconfirmed partial response, as of July 17,
2017, which was subsequently confirmed.
Consistent with global written regulatory correspondence, the
NDA/MAA dataset includes adult and pediatric tropomyosin receptor
kinase (TRK) fusion patients enrolled in Loxo Oncology’s Phase 1
adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric
trial (SCOUT). The dataset is based on the intent to treat (ITT)
principle, using the first 55 TRK fusion patients with
RECIST-evaluable disease enrolled to the three clinical trials,
regardless of prior therapy or tumor tissue diagnostic method. The
primary endpoint for the integrated analysis of efficacy is overall
response rate (ORR) according to the independent review committee
assessment, as measured by RECIST v1.1. A key secondary endpoint is
ORR according to local investigator assessment, as measured by
RECIST v1.1.
The larotrectinib adverse event profile is consistent with data
previously presented publicly.
The larotrectinib program has continued to enroll and treat
newly identified patients with TRK fusion cancers, beyond the 55
patients described above. The anti-tumor activity and safety of
larotrectinib in these additional patients are consistent with data
reported today and previously. Notably, no new patients with CNS
metastases have been identified or treated in any setting.
About Larotrectinib (LOXO-101)Larotrectinib 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 analysis of 55 RECIST-evaluable TRK fusion adult and
pediatric patients, larotrectinib demonstrated a 75 percent
independently-reviewed confirmed overall response rate (ORR) and an
80 percent investigator-assessed confirmed ORR, across many
different types of solid tumors. Larotrectinib has been granted
Breakthrough Therapy Designation Rare Pediatric Disease Designation
and Orphan Drug 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 TRK Fusion CancerTRK fusions are
chromosomal abnormalities that occur when one of the NTRK genes
(NTRK1, NTRK2, NTRK3) becomes abnormally connected to another,
unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in
uncontrolled TRK signaling that can lead to cancer. TRK fusions
occur rarely but broadly in various adult and pediatric solid
tumors, including appendiceal cancer, breast cancer,
cholangiocarcinoma, colorectal cancer, GIST, infantile
fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of
the salivary gland, melanoma, pancreatic cancer, thyroid cancer,
and various sarcomas. TRK fusions can be identified through various
diagnostic tests, including targeted next-generation sequencing
(NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR),
and fluorescent in situ hybridization (FISH). For more information,
please visit www.TRKtesting.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, the potential therapeutic benefits
and economic value of our lead product candidate or other product
candidates, 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
1AB Media973-271-6085
dan@1abmedia.com
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