Repare Therapeutics claims Lunre+Camo is effective in gynecologic cancers

On December 12, 2024, Repare Therapeutics Inc released promising data from its MYTHIC Phase 1 gynecologic expansion trial targeting endometrial cancer and platinum-resistant ovarian cancer. The trial evaluated a combination therapy known as lunresertib and camonsertib, abbreviated as Lunre+Camo. This treatment was tested on patients harboring lunre-sensitizing biomarkers, with a particular focus on safety and efficacy criteria. The study succeeded in enrolling 51 evaluable patients by the cut-off date of November 14. The trial's findings indicated that the most frequent adverse event reported was anemia, which affected 26.9% of patients at Grade 3 severity. Despite this side effect, the trial results showed significant response rates across various patient cohorts, illustrating potential clinical benefits from the treatment. Among the 27 evaluable patients with endometrial cancer, the overall response rate reached 25.9%, with confirmed responses in five out of seven patients. Moreover, the trial evidenced a 48.1% clinical benefit rate, with many patients showing responses after 12 weeks or longer. At the 24-week landmark analysis, it was noted that nearly half of the patients, or 43%, experienced durable clinical benefits. Results showed an overall response rate of 37.5% with a confirmation in four out of nine patients who presented with clinical benefits observed in 79% of these patients. The landmark analysis also reported a PFS of 45%. Repare Therapeutics has actively engaged with regulatory bodies such as the FDA and the European Medicines Agency to synchronize their developmental strategy for Lunre+Camo in treating gynecologic tumors. Following this guidance, the company is preparing to provide the final protocols for a Phase 3 trial for regulatory approval, signifying their serious intent to advance this treatment option in the cancer therapy market. Plans are in motion to initiate the Phase 3 trial for endometrial cancer in the second half of 2025, highlighting the urgency and commitment of Repare in addressing this serious health issue. Furthermore, in early 2025, Repare aims to roll out a small contribution components trial involving up to 40 patients with endometrial cancer, indicating a progressive strategy for exploring the therapeutic potentials of Lunre+Camo. The combination of lunresertib and camonsertib is thus positioned as a significant advance in addressing challenging cancer types affecting women. The trial results, consulted with regulatory entities, may facilitate quicker pathways to clinical adoption, increasing the prospects for new treatments available for patients suffering from these cancers.