Repare Therapeutics Doses First Patient in Camonsertib Monotherapy Non-Small Cell Lung Cancer Expansion of TRESR Clinical Trial

Rhea-AI Summary

Repare Therapeutics (Nasdaq: RPTX) has dosed the first patient in the expansion of its TRESR clinical trial, focusing on camonsertib monotherapy for non-small cell lung cancer (NSCLC) with ATM mutations. This expansion follows the rapid return of global rights to Repare. The TRESR trial aims to address the unmet need of over 5,000 patients with recurrent NSCLC in the US, UK, and top EU markets. Current treatments offer progression-free survival of around four months. The trial will enroll up to 20 patients to evaluate the efficacy of camonsertib at the recommended Phase 2 dose, with data expected in 2025.

Positive

• Dosing of the first patient in the NSCLC expansion of the TRESR trial.
• Rapid initiation of the trial less than a month after regaining global rights.
• Targeting a high unmet need for over 5,000 patients with ATM-mutated NSCLC.
• Potentially prolonged progression-free survival compared to current treatments.
• Established safety profile of camonsertib.
• Data readout expected in 2025, offering a clear timeline for stakeholders.

Negative

• The trial is in Phase 1/2, indicating early stages of clinical development.
• sample size with only up to 20 patients in the NSCLC expansion.
• Potentially long wait for data readout until 2025.
• Uncertainty about the ultimate efficacy and market approval of camonsertib.

Insights

Oncology Doctor

Camonsertib, as mentioned, aims to address non-small cell lung cancer (NSCLC) patients with ATM mutations. ATM mutations affect DNA repair mechanisms, making tumors potentially more susceptible to targeted therapies. The fact that camonsertib has shown promising progression-free survival (PFS) in initial trials is significant. ATM-mutated NSCLC patients, who typically have poor outcomes with current treatments, could benefit greatly from an effective targeted therapy. Prolonged PFS is a key metric in cancer treatments, indicating the time during which a patient's cancer does not worsen. If camonsertib can improve PFS significantly beyond the current standard (approximately four months), it would be a substantial advancement. The trial expansion and the rapid initiation of patient dosing suggest a strong confidence in camonsertib's potential efficacy and safety.

However, it's critical to remain cautiously optimistic until more substantial data, especially from larger cohorts, becomes available. Early results can be promising, but they need to be validated over time and across more diverse patient groups.

Medical Research Analyst

From a medical research perspective, the TRESR trial's design is robust, covering multiple critical endpoints such as safety, tolerability, pharmacokinetics (how the drug is absorbed, distributed, metabolized and excreted) and pharmacodynamics (the effects of the drug on the body). The fact that the trial is a Phase 1/2 study means it is still relatively early in clinical development, focusing primarily on safety and initial efficacy.

One notable aspect is the use of a biomarker-driven approach, selecting patients with specific ATR-inhibitor sensitizing mutations. This precision medicine strategy aligns well with modern oncology trends, aiming to tailor treatments to individual genetic profiles. The global rights reacquisition and the swift commencement of the patient dosing demonstrate Repare's commitment and operational efficiency.

Nevertheless, investors should be aware of the inherent risks associated with early-stage clinical trials. Success in these trials is not guaranteed and setbacks can lead to significant delays and financial implications.

Market Research Analyst

From a market analysis standpoint, targeting a niche but significant population of over 5,000 patients in major markets (USA, UK, top EU countries) indicates a well-defined strategy to address unmet needs in NSCLC treatments. The market for NSCLC therapies is substantial and a successful new treatment can capture significant market share, especially one that offers a convenient oral administration and a favorable safety profile as indicated.

Moreover, the anticipated data readout in 2025, while a few years away, provides a clear timeline for potential milestones that investors can watch. This can generate interest and support stock price movements as the company announces interim results. However, the long timeline also introduces the risk of competitive advancements and market dynamics changing in the interim.

CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)-- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial.

“Camonsertib has demonstrated a promising signal of prolonged progression free survival in patients with ATM-mutated NSCLC in our ongoing TRESR clinical trial. We are thrilled with the rapid and efficient expansion of this clinical trial with the treatment of the first patient less than one month from the return of camonsertib global rights to Repare,” said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. “Our biomarker-driven approach with camonsertib monotherapy has the potential to address the high unmet need of over 5,000 patients with ATM-mutated NSCLC in the tumor recurrence setting, across the United States, UK and top four EU markets, where unfortunately, the current standard of care provides progression free survival of approximately four months and low response rates.”

The TRESR (Treatment Enabled by SNIPRx) clinical trial (NCT04497116) is a multicenter, open-label, dose-escalation and expansion Phase 1/2 clinical trial to investigate safety and tolerability, pharmacokinetics, pharmacodynamics, and the anti-tumor activity of camonsertib alone or in combinations. The NSCLC expansion is expected to enroll up to 20 patients with ATR-inhibitor sensitizing mutations in NSCLC to study the efficacy of camonsertib at the recommended Phase 2 dose. With limited treatments for recurrent NSCLC, camonsertib offers a highly desirable oral therapy option with an established safety profile. Repare expects a potential data readout in the camonsertib monotherapy NSCLC expansion in 2025.

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 preclinical Polθ ATPase inhibitor program; as well as additional, undisclosed preclinical programs. For more information, please visit reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn.

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 design, objectives, initiation, enrollment, timing, progress and results of current and future preclinical studies and clinical trials of the Company’s product candidates, including its Phase 1/2 TRESR trial of camonsertib, including the NSCLC expansion of the trial; the potential of camonsertib monotherapy to address the high unmet need of patients ATM-mutated NSCLC in the tumor recurrence setting; the potential market size for camonsertib; and the benefits and ability to discover further targets and clinical candidates from the Company’s discovery platform. 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 between Israel and Hamas, 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 collaborations 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on February 28, 2024, 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 at https://www.linkedin.com/company/repare-therapeutics/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240610868857/en/

Investor Relations & Media:

Robin Garner

Vice President and Head of Investor Relations

Repare Therapeutics Inc.

investor@reparerx.com

Source: Repare Therapeutics Inc.

FAQ

What is the focus of Repare Therapeutics' latest clinical trial?

The latest clinical trial focuses on camonsertib monotherapy for non-small cell lung cancer (NSCLC) with ATM mutations.

What is the stock symbol for Repare Therapeutics?

The stock symbol for Repare Therapeutics is RPTX.

When was the first patient dosed in the camonsertib NSCLC expansion trial?

The first patient was dosed in the camonsertib NSCLC expansion trial less than one month after the global rights to camonsertib returned to Repare.

How many patients will be enrolled in the NSCLC expansion of the TRESR trial?

The NSCLC expansion of the TRESR trial is expected to enroll up to 20 patients.

What is the expected timeline for the data readout from the camonsertib NSCLC expansion trial?

Repare Therapeutics expects a potential data readout from the camonsertib NSCLC expansion trial in 2025.

What is the current standard of care for recurrent NSCLC with ATM mutations?

The current standard of care provides a progression-free survival of approximately four months with low response rates.