Repare Therapeutics Advances Oncology Pipeline with Multiple Clinical Trials
Key Insights
Repare Therapeutics' MYTHIC trial shows reduced Grade 3 anemia with lunresertib and camonsertib combination, with FDA agreement on RP2D.
Phase 2 TRESR expansion initiated to evaluate camonsertib monotherapy in NSCLC (search) patients with ATM (search) mutations, with initial data expected in 2025.
First patient dosed in Phase 1 LIONS trial for PLK4 (search) inhibitor RP-1664, expanding Repare's portfolio of precision oncology therapeutics.
Repare Therapeutics is making strides in its clinical-stage precision oncology programs, with multiple trials underway and key milestones anticipated in the near term. The company's diverse pipeline includes inhibitors targeting various cancer vulnerabilities, reflecting a commitment to synthetic lethality approaches in drug development.
Lunresertib and Camonsertib Combination Shows Promise
The Phase 1 MYTHIC clinical trial evaluating the combination of lunresertib (RP-6306) and camonsertib (RP-3500) has demonstrated a significant reduction in Grade 3 anemia. As of March 2024, the incidence of Grade 3 anemia decreased to 25% in patients treated at the recommended Phase 2 dose (RP2D) with an updated dosing schedule, compared to 45% previously reported in September 2023. The FDA has agreed with the RP2D of lunresertib 80mg BID and camonsertib 80mg QD. Repare anticipates presenting data from the dose expansion cohorts in patients with ovarian and endometrial cancer (search) in Q4 2024, aiming to determine the best opportunity for a registrational trial in 2025.
Novel Combinations and Monotherapy Approaches
Repare has also dosed the first patient in a Phase 1 MYTHIC clinical trial evaluating lunresertib in combination with Debio 0123, a WEE1 (search) inhibitor. This trial marks the first clinical investigation inhibiting both PKMYT1 (search) and WEE1, exploring potential synergies in advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations. Initial data from this trial is expected in 2025. Furthermore, the company is initiating a Phase 2 TRESR expansion in approximately 20 patients with ATM (search)-mutated (ATMm) NSCLC (search) to assess camonsertib monotherapy. This expansion is supported by early signals from the ongoing Phase 1/2 TRESR trial, with initial data anticipated in 2025.
Advancing PLK4 Inhibition with RP-1664
The first patient has been dosed in the Phase 1 LIONS trial of RP-1664, a polo-like kinase 4 (PLK4 (search)) inhibitor. This multicenter, open-label, dose-escalation trial is enrolling adult and adolescent patients with TRIM37-high and other biomarkers, further expanding Repare's clinical portfolio.
Expanding Pipeline with Polθ Inhibitor RP-3467
Repare plans to initiate a Phase 1 dose-finding trial of RP-3467, a Polθ ATPase (search) inhibitor, in the second half of 2024. The company believes RP-3467 has the potential to be a best-in-class Polθ inhibitor, adding another promising asset to its pipeline.
Financial Position and Future Outlook
As of March 31, 2024, Repare Therapeutics reported $237.0 million in cash, cash equivalents, and marketable securities. The company believes these resources are sufficient to fund its current operational plans into mid-2026. With a diverse clinical pipeline and a focus on precision oncology, Repare is poised to deliver multiple clinical readouts and advance its programs toward potential registration trials.