CAMBRIDGE, Mass. & MONTREAL - Repare Therapeutics Inc. (NASDAQ: RPTX), a precision oncology company, has announced positive outcomes from its MYTHIC Phase 1 clinical trial, evaluating a drug combination for endometrial cancer and platinum-resistant ovarian cancer. The combination of lunresertib and camonsertib showed a 25.9% overall response rate in endometrial cancer and 37.5% in platinum-resistant ovarian cancer.
Patients in the trial, all of whom had high-risk profiles and had undergone multiple previous treatments, demonstrated nearly 50% progression-free survival at 24 weeks. This performance is notably better than current standard treatments.
Based on these results, Repare plans to initiate a Phase 3 trial for the drug combination in endometrial cancer in the second half of 2025. The company has already received positive feedback from regulatory agencies in the U.S. and Europe. According to InvestingPro data, Repare maintains a strong financial position with more cash than debt on its balance sheet, and three analysts have recently revised their earnings estimates upward for the upcoming period.
The MYTHIC trial included 51 patients with gynecologic cancers, and the drug combination was well-tolerated compared to other therapies, with anemia being the most common adverse event.
Dr. Brian Slomovitz, Director of Gynecologic Oncology at Mount Sinai Medical (TASE:PMCN) Center, emphasized the urgent need for new treatments for patients with recurrent gynecologic cancers. He noted that the biomarker-driven approach of Repare's therapy could offer a much-needed solution.
Repare has engaged with the FDA and the European Medicines Agency to align on the proposed registrational development approach for the drug combination. The company also plans to conduct a smaller trial in the first quarter of 2025 to assess the contribution of the drug components.
Repare's Chief Medical Officer, Dr. Maria Koehler, expressed gratitude to the trial participants and optimism for the potential of the drug combination to become a new standard of care for aggressive recurrent endometrial cancer, pending approval.
The company will host a conference call and webcast today to discuss these findings further. This article is based on a press release statement from Repare Therapeutics Inc. While the company currently maintains a healthy current ratio of 6.45 and strong liquidity position, InvestingPro subscribers have access to over 30 additional financial metrics and insights that could help evaluate the investment potential of Repare Therapeutics more comprehensively.
In other recent news, Repare Therapeutics has made significant strides in its clinical trials and operations. The company has partnered with the US National Cancer Institute's Cancer Therapy Evaluation Program to advance the development of its anticancer drug camonsertib. Phase 1 MYTHIC clinical trial data indicates that an individualized treatment schedule can effectively manage anemia, a common side effect of cancer therapy. Additionally, Repare has initiated a Phase 1 clinical trial for RP-3467, a Polθ ATPase inhibitor designed for cancer treatment.
Analyst firms Piper Sandler, Stifel, and H.C. Wainwright have maintained their positive ratings for Repare Therapeutics following these developments. The U.S. Food and Drug Administration has also granted Fast Track designation to the company's ovarian cancer drug combination, lunresertib, and camonsertib.
In a strategic move, Repare Therapeutics has shifted its research and development focus, which is expected to result in significant annual cost savings of around $15.0 million and extend the company's cash runway into the second half of 2026. Lastly, the company's board of directors has seen a reshuffle, with Steven H. Stein, M.D., assuming the role of chair of the Science and Technology Committee.
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