Repare Therapeutics Announces Updated Positive Safety and Tolerability Results from the Phase 1 MYTHIC Clinical Trial
23 Outubro 2024 - 7:05AM
Business Wire
Data presented at EORTC-NCI-AACR Symposium on
Molecular Targets and Cancer Therapeutics
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
presented updated data highlighting the benefits of its
individualized schedule for the management of anemia in the Phase 1
MYTHIC clinical trial treating patients with the combination of
lunresertib, a first-in-class PKMYT1 inhibitor, and camonsertib, a
potential best-in-class oral small molecule ATR inhibitor
(lunre+camo).
Lunre+camo in the MYTHIC clinical trial (NCT04855656) previously
demonstrated promising clinical activity in molecularly selected
patients across multiple tumor types. In this analysis, Repare
followed patients for approximately nine months at the recommended
Phase 2 dose (RP2D) to assess the effectiveness of an
individualized schedule. The analysis demonstrated a successful
approach to mitigating mechanism-based anemia while maintaining
clinical benefit. Further, Repare observed no thrombocytopenia of
any grade nor serious neutropenia in these patients.
Dr. Martin Højgaard of Rigshospitalet, Denmark presented this
data in a poster titled, “Individualized schedule improves rates
and severity of anemia in patients treated with lunresertib, a
PKMYT1 inhibitor, and camonsertib, an ATR inhibitor, in the Phase I
MYTHIC study (NCT04855656)” at the 36th EORTC-NCI-AACR (ENA)
Symposium on Molecular Targets and Cancer Therapeutics, being held
October 23-25, 2024 in Barcelona, Spain.
“This individualized schedule in heavily pretreated patients
with advanced cancers from our MYTHIC clinical trial met its goal
of maintaining antitumor activity while reducing rates of grade 3
anemia,” said Maria Koehler, MD, PhD, Executive Vice President and
Chief Medical Officer of Repare. “We believe that these data
demonstrate a favorable and differentiated tolerability profile
versus both current and emerging therapies. We look forward to
sharing efficacy data from the gynecological cancer expansion
cohort of the MYTHIC clinical trial in December 2024.”
Key Clinical Trial Findings:
- The individualized schedule mitigated mechanism-based anemia
based on entry hemoglobin observed in a minority of patients
- Overall clinical benefit was maintained after schedule change
with generally maintained radiographic regressions and molecular
responses: - Despite the change in schedule, deepening of target
lesion regression was noted in some patients - After 9 weeks on
therapy, there was no observed impact on Progression Free Survival
(PFS) in patients who started on or switched to the schedule of 2
weeks on / 1 week off of treatment
- Dose optimization meaningfully reduced Grade 3 anemia (22.6%
vs. 51.4%, previously) in all patients: - Baseline marrow function
was the key reason for Grade 3 anemia as opposed to exposure to
therapy - Baseline hemoglobin, prior therapies, and treatment
intensity (weekly vs. 2 weeks on / 1 week off) predicted Grade 3
anemia frequency with lunre+camo - Anemia reduction was greatest in
patients with baseline hemoglobin less than 11g/dL (Grade 3 anemia
at week 12: 34% vs. 68%, previously; overall risk reduction: 58%) -
Red blood cell transfusions (13% vs. 43%, previously), dose
interruptions (13% vs. 23%) and dose reductions (6% vs. 17%) were
also reduced with the new schedule - Other Grade 3 events were
already uncommon (<5% incidence) and remained consistently low,
regardless of schedule
About Repare Therapeutics Inc.
Repare Therapeutics is a leading clinical-stage precision
oncology company enabled by its proprietary synthetic lethality
approach to the discovery and development of novel therapeutics.
The Company utilizes its genome-wide, CRISPR-enabled SNIPRx®
platform to systematically discover and develop highly targeted
cancer therapies focused on genomic instability, including DNA
damage repair. The Company’s pipeline includes lunresertib (also
known as RP-6306), a PKMYT1 inhibitor currently in Phase 1/2
clinical development; camonsertib (also known as RP-3500), a
potential leading ATR inhibitor currently in Phase 1/2 clinical
development; RP-1664, a Phase 1 PLK4 inhibitor; RP-3467, a Phase 1
Polθ ATPase inhibitor; as well as additional, undisclosed
preclinical programs. For more information, please visit
reparerx.com and follow @Reparerx on X (formerly Twitter) and
LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
and securities laws in Canada. All statements in this press release
other than statements of historical facts are “forward-looking
statements. These statements may be identified by words such as
“aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will” and variations of these words or
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding the design,
objectives, timing, progress and results of the Phase 1 MYTHIC
clinical trial of camonsertib in combination with lunresertib; and
the tolerability, efficacy and clinical progress of the Company’s
product candidates, including camonsertib and lunresertib. These
forward-looking statements are based on the Company’s expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties that
could cause the Company’s clinical development programs, future
results or performance to differ materially from those expressed or
implied by the forward-looking statements. Many factors may cause
differences between current expectations and actual results,
including: the potential that success in preclinical testing and
earlier clinical trials does not ensure that later clinical trials
will generate the same results or otherwise provide adequate data
to demonstrate the efficacy and safety of a product candidate; the
impacts of macroeconomic conditions, including the conflict in
Ukraine and the conflict in the Middle East, heightened inflation
and uncertain credit and financial markets, on the Company’s
business, clinical trials and financial position; unexpected safety
or efficacy data observed during preclinical studies or clinical
trials; clinical trial site activation or enrollment rates that are
lower than expected; the Company’s ability to realize the benefits
of its collaboration and license agreements; changes in expected or
existing competition; changes in the regulatory environment; the
uncertainties and timing of the regulatory approval process; and
unexpected litigation or other disputes. Other factors that may
cause the Company’s actual results to differ from those expressed
or implied in the forward-looking statements in this press release
are identified in the section titled "Risk Factors" in the
Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2024 filed with the Securities and Exchange Commission (“SEC”)
and the Québec Autorité des Marchés Financiers ("AMF") on August 6,
2024, 2024. The Company expressly disclaims any obligation to
update any forward-looking statements contained herein, whether as
a result of any new information, future events, changed
circumstances or otherwise, except as otherwise required by law.
For more information, please visit reparerx.com and follow Repare
on X (formerly Twitter) at @RepareRx and on LinkedIn at
https://www.linkedin.com/company/repare-therapeutics/.
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version on businesswire.com: https://www.businesswire.com/news/home/20241023356708/en/
Investor Relations & Media Contact: Robin Garner Vice
President and Head of Investor Relations Repare Therapeutics Inc.
investor@reparerx.com
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