Full Press Release Details
Repare Therapeutics Presents Initial Clinical Data from the Phase 1/2 TRESR and ATTACC
Trials Evaluating Camonsertib in Combination with Three PARP Inhibitors at the 2023
Camonsertib PARPi combinations demonstrated 48% CBR in patients with unmet medical needs, across tumor types, and regardless of PARPi
partner or platinum resistance, with a favorable safety and tolerability profile
Combination results showed most benefit in
late-line ovarian cancer demonstrating 32% overall response, 58% CBR and mPFS of approximately 7 months
Early ctDNA molecular
responses in 66% of evaluable patients confirms antitumor activity of low dose intermittent PARPi + ATRi therapy
CAMBRIDGE, Mass. & MONTREAL
(BUSINESS WIRE) April 18, 2023 Repare Therapeutics Inc. ( Repare or the Company ) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today presented initial data from its ongoing Phase 1/2 TRESR
clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), in combination
with a poly (ADP-ribose) polymerase inhibitor (PARPi), talazoparib, and initial data from its ongoing Phase 1b/2 ATTACC clinical trial, evaluating camonsertib in combination with two additional PARPis,
niraparib or olaparib, in patients with advanced solid tumors.
The data involving novel combinations of low doses of camonsertib and three different
PARPis are featured today at the 2023 AACR Annual Meeting in a clinical plenary session titled, Safety and efficacy of three PARP inhibitors (PARPi) combined with the ataxia telangiectasia- and Rad3-related kinase inhibitor (ATRi) camonsertib
in patients (pts) with solid tumors harboring DNA damage response (DDR) alterations (abstract presentation number CT018). This study population comprised patients with a broad range of historically difficult to treat tumors, including patients
with platinum-resistant tumors, patients who had either recurred or progressed during or after treatment with PARPis, and patients who had developed known BRCA-reversion mutations.
We see promise in the camonsertib-PARPi combinations when administered concomitantly, at low doses across tumor types, especially in recurrent ovarian
cancer given that nearly all had recurred after prior PARPi treatment. We are particularly encouraged by the depth of response and duration of treatment, said Maria Koehler, MD, PhD, Chief Medical Officer of Repare. Dose optimization to
refine the combinatorial dose in additional tumor-specific expansions beyond ovarian within our ATTACC study is ongoing as part of our collaboration with Roche.
We previously established a promising safety and early efficacy profile of camonsertib as a monotherapy and this year s data at AACR further
support camonsertib as a partner for combinational regimens and provides a clear rationale for further development of this compound, said Lloyd M. Segal, President and Chief Executive Officer of Repare. Notably, the circulating tumor DNA
(ctDNA) data showed a strong correlation with the degree of tumor shrinkage and duration of disease control, and provide a mechanistic explanation for the
observed durable clinical benefit in heavily pretreated patients, beyond the natural history of the disease. We look forward to refining our dose optimization efforts and efficacy assessment in
tumor specific expansions. This data remains consistent with what we were anticipating at the time of entering our partnership with Roche and we are excited to continue this important clinical development together.
Key Initial Findings from the TRESR Phase 1/2 and ATTACC 1b/2 PARPi Combination Studies:
TRESR (NCT04497116) is a first-in-human, multi-center, open-label Phase 1/2
dose-escalation and expansion study, designed to establish the recommended Phase 2 dose and schedule, evaluate safety and pharmacokinetics and identify preliminary anti-tumor activity associated with camonsertib, given alone and in combination with
talazoparib or in combination with gemcitabine.
ATTACC (NCT04972110) is a
first-in-human, multi-center, open-label Phase 1b/2 dose-escalation and expansion study, designed to evaluate safety and pharmacokinetics and identify preliminary
anti-tumor activity associated with camonsertib in combination with niraparib or olaparib.
The clinical plenary session described initial combination
Phase 1/2 results from 107 patients, of which 90 patients were evaluable for efficacy treated at least 13 weeks prior to the data cutoff of February 27, 2023.
Key highlights from the data presented at the 2023 AACR Annual Meeting include:
Additional relevant presentations at AACR:
Title: Characterization of CCNE1 amplifications and associated genomic features in ovarian and uterine cancers
Session: Biomarkers of Therapeutic Benefit 5, Tuesday April 18, 2023, 1:30 PM - 5:00 PM
Abstract Number: 5469
Title: Tumor heterogeneity of CCNE1 copy number assessed by fluorescence in
situ hybridization (FISH) in ovarian and uterine cancers and correlation with cyclin E protein expression
Session: Biomarkers of
Therapeutic Benefit 2, Monday April 17, 2023, 9:00 AM - 12:30 PM
Abstract Number: 2132
Title: Targeting PKMYT1 kinase is an effective treatment strategy in triple negative breast cancers with low molecular weight cyclin E (LMW-E) expression
Session: Biomarkers of Therapeutic Benefit 1, Sunday April 16, 2023, 1:30 PM -
Abstract Number: 950
Investigating Wee1 and Myt1 combined inhibition as a potential cancer therapeutic strategy Session: Combination Therapies for Cancer, Tuesday April 18, 2023, 1:30 PM - 5:00 PM
Abstract Number: 5511
About Repare Therapeutics
SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding
patients who are most likely to benefit from the Company s therapies based on the genetic profile of their tumors. Repare s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic
alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
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 RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development; camonsertib (also known as RP-3500 or RG6526), a potential leading ATR inhibitor currently in Phase 1/2
clinical development and partnered with Roche; a preclinical Pol inhibitor program; as well as several additional, undisclosed preclinical programs. For more information, please visit
SNIPRx is a registered trademark of Repare Therapeutics Inc.
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 safety, efficacy and clinical progress of the
Company s clinical trials of camonsertib and the Company s continued development of camonsertib in partnership with Roche. 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 impacts of macroeconomic conditions, including the COVID-19 pandemic, the conflict in Ukraine, rising 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; 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 Annual Report on Form 10-K for the year
ended December 31, 2022 filed with the Securities and Exchange Commission ( SEC ) and the Qu bec Autorit des March s Financiers ( AMF ) on February 28, 2023, and its other
documents subsequently filed with or furnished to the SEC and AMF. 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 Twitter at @RepareRx and on LinkedIn
Executive Director and Head of Investor Relations
Repare Therapeutics Inc.