Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today announced that abstracts from its LOXO-292
and larotrectinib programs have been accepted for presentation at
the International Association for the Study of Lung Cancer (IASLC)
19th World Conference on Lung Cancer to be held September 23-26,
2018, in Toronto, Canada.
The LOXO-292 oral presentation will provide an updated analysis
of patients with RET fusion non-small cell lung cancer (NSCLC)
enrolled in the dose escalation cohorts of the ongoing LIBERTTO-001
Phase 1/2 clinical trial. The larotrectinib poster will provide an
analysis of patients with TRK fusion NSCLC enrolled to the
larotrectinib clinical program.
The schedule for the presentations is as follows:
LOXO-292 Oral Presentation Session Date
& Time: September 25, 2018, 3:15-4:45 p.m.
ETTitle: Clinical Activity of LOXO-292, a Highly
Selective RET Inhibitor, in Patients with RET Fusion+ Non-Small
Cell Lung CancerAbstract Number:
13922Session Title: Novel Therapies in MET, RET
and BRAFPresenter: Geoffrey R. Oxnard, M.D.
Larotrectinib Poster Presentation
Session Date & Time: September 24, 2018, 9:45
a.m.-6:00 p.m. ETTitle: Rapid, Robust and Durable
Responses to Larotrectinib in Patients with TRK Fusion Non-Small
Cell Lung CancerAbstract Number:
14528Session Title: Targeted
TherapyPresenter: Anna F. Farago, M.D., Ph.D.
About LOXO-292 LOXO-292 is a potent, 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 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 Larotrectinib Larotrectinib is an oral
and highly 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, 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 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 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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