– 94 Percent of All Pediatric Patients Remain on
Larotrectinib or Received Surgery with Curative Intent –
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today announced updated
clinical data from the larotrectinib pediatric Phase 1 SCOUT
clinical trial. These data are being presented today at the
American Association for Cancer Research (AACR) Special Conference
on Pediatric Cancer Research in Atlanta.
“Targeted therapy success stories in pediatric oncology are
uncommon, and larotrectinib has invigorated the pediatric oncology
community,” said Brian Turpin, D.O., the presenting SCOUT principal
investigator and assistant professor in the division of oncology at
Cincinnati Children’s Hospital. “Larotrectinib’s near universal
response rate and compelling durability of response in pediatric
patients with TRK fusion cancers is likely to be practice changing.
Furthermore, the first-ever TRK inhibitor response in a TRK fusion
glioblastoma patient highlights the potential for larotrectinib in
TRK fusion central nervous system tumors.”
“We are grateful to the children and families who have enabled
the development of larotrectinib through their participation in
clinical trials,” said Josh Bilenker, M.D., chief executive officer
of Loxo Oncology.
As of a July 17, 2017 data cut-off date, 24 pediatric patients
were enrolled in the dose escalation portion of the Phase 1 trial,
including 17 patients with TRK fusion cancers. TRK fusion patients
carried primary diagnoses of infantile fibrosarcoma, thyroid
cancer, and various soft tissue sarcomas.
|
|
TRK Fusion Patients (n=17)* |
|
Patients without TRK Fusions (n=7) |
|
Independent Review Committee Assessed
Response |
Investigator Assessed Response |
|
Investigator Assessed Response |
Overall Response Rate(ORR = PR+CR) |
93%(95% CI: 68% – 100%) |
93%(95% CI: 68% – 100%) |
|
0% |
Partial Response (PR) |
80% |
67%** |
|
0% |
Complete Response (CR) |
13% |
27% |
|
0% |
Stable Disease |
7% |
7% |
|
0% |
Progressive Disease |
0% |
0% |
|
100% |
* 2
patients not evaluable due to having non-measurable disease at
baseline. |
**
Includes 2 patients with unconfirmed partial responses as of July
17, 2017, which were subsequently confirmed. |
|
Among the 17 patients with TRK fusion cancers, 94% either remain
on drug or received surgery with curative intent; four patients
have been followed greater than one year and 12 have been followed
greater than six months.
The larotrectinib adverse event profile is consistent with data
previously presented publicly. The most common treatment-related
adverse events at the Phase 2 dose included increased liver
function tests, neutropenia, and nausea, all largely grade 1.
These data are being presented in a poster session on December
4, 2017 and an oral presentation on December 5, 2017. The poster
and presentation will be available online at
https://www.loxooncology.com/focus/publications-abstracts at the
time of their scheduled presentations.
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.
In November 2017, Loxo Oncology and Bayer entered into an
exclusive global collaboration for the development and
commercialization of larotrectinib and LOXO-195, a next-generation
TRK inhibitor. Loxo Oncology leads worldwide development and U.S.
regulatory activities. Bayer leads ex-U.S. regulatory activities
and worldwide commercial activities. In the U.S., Loxo Oncology and
Bayer will co-promote the products.
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, including Loxo Oncology’s expectations
regarding the timing and success of our clinical trials.
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. 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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