Repare Therapeutics' Lunresertib Combo Gains FDA Fast Track for Platinum-Resistant Ovarian Cancer

Repare Therapeutics Inc., a prominent precision oncology company at the clinical stage, has made a significant announcement. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to their combination therapy of lunresertib and camonsertib for the treatment of adult patients with platinum-resistant ovarian cancer that have specific genetic mutations. These mutations include CCNE1 amplification, or FBXW7 or PPP2R1A mutations.

Currently, the combination therapy of lunresertib and camonsertib is under evaluation in Repare's MYTHIC Module 2 Phase 1 dose expansion clinical trial. This trial targets patients with ovarian and endometrial cancers that exhibit the genetic mutations mentioned. Besides the recent Fast Track designation for ovarian cancer, the FDA had previously awarded the same status to the combination for treating endometrial cancer with similar genetic alterations in the third quarter of 2023. Repare plans to share data from these trials, involving approximately 20-30 patients each, by the fourth quarter of 2024.

Maria Koehler, MD, PhD, the Executive Vice President and Chief Medical Officer at Repare, expressed that the FDA's decision aligns with their aim to develop the lunresertib-camonsertib combination swiftly for patients with platinum-resistant ovarian cancer defined by their genomic profile. Koehler emphasized the need for therapies that provide long-term benefits over the standard care for ovarian cancer patients. Repare's precision medicine approach focuses on offering well-tolerated alternatives to chemotherapy, targeting patients who are most likely to benefit based on their genomic makeup.

The FDA's Fast Track process is tailored to expedite the development and review of therapies for serious conditions that address unmet medical needs, aiming to bring important new treatments to patients earlier. Programs granted Fast Track designation are eligible for frequent interactions with the FDA throughout clinical development. This process may also potentially lead to accelerated approval or priority review if certain criteria are met.

Repare Therapeutics leverages its proprietary SNIPRx® platform for its research and development. This platform employs a genome-wide CRISPR-based screening approach using isogenic cell lines to identify synthetic lethal gene pairs. This technology helps pinpoint the patients who are most likely to benefit from Repare's therapies based on the genetic profile of their tumors. Consequently, the SNIPRx® platform enables the development of precision therapeutics for patients with specific genomic alterations.

Repare's pipeline includes several promising candidates. Lunresertib, also known as RP-6306, is a PKMYT1 inhibitor currently in Phase 1/2 clinical development. Camonsertib, or RP-3500, is a potential leading ATR inhibitor also in Phase 1/2 clinical development. Additionally, RP-1664, a Phase 1 PLK4 inhibitor, and RP-3467, a preclinical Polθ ATPase inhibitor, are part of their development programs. The company is also working on other undisclosed preclinical programs.

Repare Therapeutics continues to drive innovation in the field of precision oncology, focusing on treatments that target genomic instability and DNA damage repair. Their efforts aim to develop highly targeted cancer therapies, offering new hope for patients with specific genetic profiles and paving the way for more personalized cancer treatments.