Ignyta Announces Compelling Phase 1/1b Clinical Data on RXDX-105, Its VEGFR-Sparing RET Inhibitor, at the 2016 EORTC-NCI-AACR...
December 01 2016 - 4:15AM
Business Wire
Preliminary Objective Response Rate of 56%
Observed in Nine RET Inhibitor-Naïve Patients with RET
Fusion-Positive Solid Tumors
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology
company focused on precision medicine in oncology, today announced
data from an ongoing Phase 1/1b study of RXDX-105—Ignyta’s
VEGFR-sparing, potent RET inhibitor—at the 2016 EORTC-NCI-AACR
(ENA) Molecular Targets and Cancer Therapeutics Symposium in
Munich, Germany, highlighting RXDX-105’s clinical activity in
patients harboring RET molecular alterations, with five out of nine
patients with RET fusion-positive cancers who were RET
inhibitor-naïve achieving a RECIST response (1 complete response, 3
partial responses, and 1 unconfirmed partial response), for a
preliminary objective response rate (ORR) of 56% (Abstract number
437, Poster number P116).
“This substantial update of our Phase 1/1b clinical data on
RXDX-105 provides compelling evidence of its potent anti-tumor
activity with promising durability and acceptable safety in
patients with RET-fusion positive tumors,” said Pratik Multani,
M.D., Chief Medical Officer of Ignyta. “With approximately 500-fold
higher potency against RET than VEGFR2 in vitro, RXDX-105 has the
potential to address a critical unmet medical need in RET-positive
patients for whom the clinical utility of multikinase inhibitors
with both RET and VEGFR activity is constrained by safety
liabilities and limited efficacy. We look forward to the
continuation of the study to further explore the safety and
efficacy of RXDX-105.”
As of the November 2016, data cut-off, the findings showed:
Safety
A total of 91 patients with a range of solid tumors have been
treated in the Phase 1/1b clinical trial, with 55 patients treated
in the Phase 1 study and 36 patients treated in the Phase 1b
study.
- RXDX-105 continues to demonstrate a
safety profile similar to what has been previously reported: across
both studies, the most common treatment-related adverse events
(>10% incidence) were rash (31%), fatigue (22%), diarrhea (20%),
nausea (18%), hypophosphatemia (14%), vomiting (14%), muscle spasms
(13%), and decreased appetite (10%);
- The majority of treatment-related
adverse events were Grade 1 or 2, and were reversible with dose
modification;
- The most common Grade 3
treatment-related adverse events (>5% incidence) were rash (9%),
hypophosphatemia (7%), and ALT increase (6%);
- One patient experienced a Grade 3 drug
reaction with eosinophilia and systemic symptoms, in which the
patient recovered with drug discontinuation. One patient
experienced Grade 3 rash complicated by fatal alveolar hemorrhage.
No other treatment-related Grade 4 or higher events were
observed.
- Toxicities commonly associated with
VEGFR inhibition, such as hypertension, hypothyroidism,
proteinuria, and neurotoxicity, were rarely observed (<5%).
Efficacy
Of the 36 patients treated in the Phase 1b study, 35 had RET or
BRAF molecular alterations.
Nine RET inhibitor-naïve patients (n = 8 in the Phase 1b cohort;
n = 1 in the Phase 1 cohort) with RET fusion-positive tumors were
treated at a daily dose of 275 mg or 350 mg in the fed state, and
were evaluable for response.
- A preliminary ORR of 56% was observed
in patients with RET fusion-positive solid tumors who were RET
inhibitor-naïve (five out of nine treated patients had a RECIST
response);
- Of the five patients demonstrating a
RECIST response, one patient with metastatic colorectal cancer
(mCRC) achieved a complete response; three patients, all with
non-small cell lung cancer (NSCLC), achieved a partial response;
and one patient with NSCLC had an unconfirmed partial
response;
- Among the seven patients with RET
fusion-positive NSCLC who were RET inhibitor-naïve, three achieved
a partial response and one achieved an unconfirmed response (a
second scan had not been obtained at the date of data cutoff), for
a preliminary ORR of 57%;
- Duration of response to RXDX-105 ranged
from 2+ to 7+ months, with all responder patients currently
continuing on treatment in active response; median duration of
response, therefore, has not yet been determined;
- Additionally, a previously disclosed
Phase 1 patient with RET-mutated M918T medullary thyroid cancer had
a confirmed partial response and continues on treatment after ten
cycles.
- These data confirm that RXDX-105 is
active across a range of different histologies, with confirmed
RECIST responses now observed in medullary thyroid cancer, NSCLC,
and mCRC, and across a range of RET molecular alterations,
including the M918T point mutation, and CCDC6-, EML4-, and
PARD3-RET fusions.
Among the remaining patients treated in Phase 1b who were either
RET fusion-positive and received prior RET inhibitor treatments (n
= 4) or had BRAF molecular alterations (n = 23), durable disease
control but no objective responses have been observed to date.
Based on the promising efficacy data observed thus far in
patients with RET fusion-positive solid tumors who are RET
inhibitor-naïve, this population will remain the primary focus of
future development of RXDX-105. Enrollment in the Phase 1b study is
ongoing to further explore the safety and efficacy of RXDX-105 in
various molecular baskets at several doses.
About Ignyta, Inc.
Blazing a New Future for Patients with
Cancer™
At Ignyta, we work tirelessly on behalf of patients with cancer
to offer potentially life-saving, precisely targeted therapeutics
(Rx) guided by companion diagnostic (Dx) tests. Our integrated
Rx/Dx strategy allows us to enter uncharted territory, illuminating
the molecular drivers of cancer and quickly advancing treatments to
address them. This approach embraces even those patients with the
rarest cancers, who have the highest unmet need and who may
otherwise not have access to effective treatment options. With our
pipeline of potentially first-in-class and best-in-class precision
medicines, we are pursuing the ultimate goal of not just shrinking
tumors, but eradicating cancer relapse and recurrence in precisely
defined patient populations.
For more information, please visit: www.ignyta.com.
Forward-Looking Statements
This press release contains forward-looking statements
about Ignyta as that term is defined in Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements in this press release that are not
purely historical are forward-looking statements. Such
forward-looking statements include, among other things, references
to the results of the Phase 1/1b clinical study of RXDX-105 and the
development and potential of Ignyta's product candidates. Actual
results could differ from those projected in any forward-looking
statements due to numerous factors. Such factors include, among
others, the inherent uncertainties associated with developing new
products or technologies and operating as a development stage
company; Ignyta's ability to develop, initiate or complete
preclinical studies and clinical trials for, obtain approvals for
and commercialize any of its product candidates; changes in
Ignyta's plans to develop and commercialize its product candidates;
the potential for final results of the ongoing clinical trials of
RXDX-105 or other product candidates, or any future clinical trials
of RXDX-105 or other product candidates, to differ from preliminary
or expected results; Ignyta's ability to raise any additional
funding it will need to continue to pursue its business and product
development plans; regulatory developments in the United
States and foreign countries; Ignyta's ability to obtain and
maintain intellectual property protection for its product
candidates; the risk that orphan drug exclusivity may not
effectively protect a product from competition and that such
exclusivity may not be maintained; the potential for Ignyta to fail
to maintain the CAP accreditation and CLIA certification of its
diagnostic laboratory; the loss of key scientific or management
personnel; competition in the industry in
which Ignyta operates; and market conditions. These
forward-looking statements are made as of the date of this press
release, and Ignyta assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements. Investors should consult all of the information set
forth herein and should also refer to the risk factor disclosure
set forth in the reports and other documents Ignyta files with
the SEC available at www.sec.gov, including without
limitation Ignyta's Annual Report on Form 10-K for the year
ended December 31, 2015, and subsequent Quarterly Reports
on Form 10-Q.
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version on businesswire.com: http://www.businesswire.com/news/home/20161201005385/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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