Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today announced that investigators will present
data from the larotrectinib and LOXO-292 programs at the European
Society for Medical Oncology (ESMO) 2018 Congress to be held
October 19-23, 2018, in Munich, Germany.
The larotrectinib oral presentation will provide updated
follow-up on the primary analysis set of 55 patients enrolled
across the larotrectinib pivotal program, as well as details on the
clinical activity of larotrectinib in additional TRK fusion
patients subsequently enrolled. The submitted abstract utilized a
February 2018 data cut-off date, and the presentation will utilize
a July 2018 data cut-off date.
Additionally, an updated analysis of patients’ plasma cell free
DNA during treatment with LOXO-292 will be presented in a separate
poster presentation.
The schedule for the presentations is as follows:
Oral Presentation Session Date &
Time: October 21, 2018, 11:00 a.m. – 12:30 p.m.
CETTitle: Larotrectinib efficacy and safety in TRK
fusion cancer: an expanded clinical dataset showing consistency in
an age and tumor agnostic approachPresentation
Number: 4090Session Title: Proffered
paper session - Developmental
therapeuticsLocation: Hall B3 - Room
22Presenter: Ulrik Lassen, M.D., Ph.D.
Poster Presentation Session Date &
Time: October 20, 2018, 12:30 p.m. – 1:30 p.m.
CETTitle: Detection and clearance of RET variants
in plasma cell free DNA (cfDNA) from patients (pts) treated with
LOXO-292Presentation Number: 105PSession
Title: Poster display session: Biomarkers, Gynaecological
cancers, Haematological malignancies, Immunotherapy of cancer, New
diagnostic tools, NSCLC - early stage, locally advanced &
metastatic, SCLC, Thoracic malignancies, Translational
researchLocation: Hall A3 - Poster Area Networking
HubPresenter: Benjamin Besse, M.D.
About Larotrectinib Larotrectinib is an oral
and selective investigational tropomyosin receptor kinase (TRK)
inhibitor in clinical development for the treatment of patients
with cancers that harbor a neurotrophic tyrosine receptor kinase
(NTRK) gene fusion. 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 clinical trials, larotrectinib demonstrated
anti-tumor activity in patients with tumors harboring NTRK gene
fusions, regardless of patient age or tumor type. In an analysis of
55 RECIST-evaluable adult and pediatric patients with NTRK gene
fusions, using a July 17, 2017 data cutoff, larotrectinib
demonstrated a 75 percent centrally-assessed confirmed overall
response rate (ORR) and an 80 percent investigator-assessed
confirmed ORR, across many different types of solid tumors. The
majority (93 percent) of all adverse events were grade 1 or 2.
Larotrectinib has been granted Priority Review, Breakthrough
Therapy Designation, Rare Pediatric Disease Designation and Orphan
Drug Designation by the U.S. FDA.
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. Bayer and Loxo Oncology are jointly developing the
two products with Loxo Oncology leading the ongoing clinical
studies as well as the filing in the U.S., and Bayer leading
ex-U.S. regulatory activities and worldwide commercial activities.
In the U.S., Loxo Oncology and Bayer will co-promote the
products.
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/trk-trials.
About TRK Fusion Cancer TRK fusion cancer
occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene
fuses with another unrelated gene, producing an altered tropomyosin
receptor kinase (TRK) protein. The altered protein, or TRK fusion
protein, is constantly active, triggering a permanent signal
cascade. These proteins become the primary driver of the spread and
growth of tumors in patients with TRK fusion cancer. TRK fusion
cancer is not limited to certain types of cells or tissues and can
occur in any part of the body. NTRK gene fusions occur in various
adult and pediatric solid tumors with varying prevalence, 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. Only sensitive and
specific tests can reliably detect TRK fusion cancer.
Next-generation sequencing (NGS) can provide a comprehensive view
of genomic alterations across a large number of genes. Fluorescence
in situ hybridization (FISH) can also be used to test for TRK
fusion cancer, and immunohistochemistry (IHC) can be used to detect
the presence of TRK protein.
About LOXO-292LOXO-292 is an oral and selective
investigational new drug in clinical development for the treatment
of patients with cancers that harbor abnormalities in the
rearranged during transfection (RET) kinase. RET fusions and
mutations occur across multiple tumor types with varying frequency.
LOXO-292 was designed to inhibit native RET signaling as well as
anticipated acquired resistance mechanisms that could otherwise
limit the activity of this therapeutic approach. LOXO-292 has been
granted Breakthrough Therapy Designation by the U.S. FDA.
LOXO-292 is currently being studied in
the global LIBRETTO-001 Phase 1/2 trial. For additional
information about the LOXO-292 clinical trial, please refer
to www.clinicaltrials.gov. Interested patients and physicians
can contact the Loxo Oncology Physician and Patient RET Clinical
Trial Hotline at 1-855-RET-4-292 or
email clinicaltrials@loxooncology.com.
About RET-Altered CancersGenomic alterations in
the RET kinase, which include fusions and activating point
mutations, lead to overactive RET signaling and uncontrolled cell
growth. RET fusions have been identified in approximately 2% of
non-small cell lung cancer, 10-20% of papillary and other thyroid
cancers, and a subset of other cancers. Activating RET point
mutations account for approximately 60% of medullary thyroid cancer
(MTC). Both RET fusion cancers and RET-mutant MTC are primarily
dependent on this single activated kinase for their proliferation
and survival. This dependency, often referred to as “oncogene
addiction,” renders such tumors highly susceptible to small
molecule inhibitors targeting RET.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company developing highly selective medicines
for patients with genomically 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, with the intention of
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 Statements This 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, the timing and success of our clinical
trials or regulatory approvals related to larotrectinib, the
success of our collaboration with Bayer and our commercial
activities. Further information on potential risk factors that
could affect our business and its financial results are detailed in
our most recent Annual Report on Form 10-K, 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:Lauren CohenDirector, Corporate
Communicationslcohen@loxooncology.com
Investors:Peter RahmerEndurance Advisors,
LLC415-515-9763prahmer@enduranceadvisors.com
Media:Dan Budwick1AB Media973-271-6085dan@1abmedia.com
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