Repare Therapeutics announced positive data from its Phase 1 MYTHIC trial combining lunresertib and camonsertib (Lunre+Camo) in patients with endometrial and platinum-resistant ovarian cancers. The combination therapy showed promising overall response rates (ORR) of 25.9% and 37.5% respectively, with nearly half the patients experiencing progression-free survival at 24 weeks. These findings stem from 51 evaluable patients enrolled in the gynecologic cancer expansion cohort, with results suggesting a favorable tolerability profile compared to current treatments.
This news holds significant promise for patients with gynecologic cancers, particularly those with endometrial or platinum-resistant ovarian cancer, who often face limited treatment options and poor prognoses after recurrence. The high response rates and extended progression-free survival observed with Lunre+Camo suggest a potential improvement over existing standards of care, offering a new therapeutic avenue for this patient population, especially given its favorable tolerability profile. Furthermore, the targeted nature of the therapy, focused on specific genetic biomarkers, underscores the growing importance of precision oncology in addressing difficult-to-treat cancers.
The MYTHIC trial evaluated Lunre+Camo at its recommended Phase 2 dose. In endometrial cancer patients, 25.9% achieved an ORR, and 48.1% maintained progression-free survival at 24 weeks. For platinum-resistant ovarian cancer patients, the ORR was 37.5%, with 45.8% exhibiting progression-free survival at 24 weeks. Notably, the therapy was well-tolerated, with anemia being the most common adverse event (26.9%, Grade 3). Repare has engaged with both the FDA and the European Medicines Agency for guidance on the registrational path forward.
These positive results pave the way for a planned Phase 3 trial of Lunre+Camo in endometrial cancer, anticipated to begin in the second half of 2025. This signifies a crucial step towards potentially establishing a new standard of care for these aggressive cancers. The combination therapy’s targeted approach and encouraging efficacy data suggest a potential shift in the treatment landscape for gynecologic oncology, offering hope for improved outcomes and a better quality of life for patients facing these challenging diseases. The data also strengthens the potential for Lunre+Camo in other cancers with similar genetic vulnerabilities.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
