On June 10, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the first patient has been dosed in the Company’s camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial (Press release, Repare Therapeutics, JUN 10, 2024, View Source [SID1234644238]).
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"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.