On Thursday, Repare Therapeutics Inc (NASDAQ:RPTX) revealed data from its MYTHIC Phase 1 gynecologic expansion trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) for endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.
As of the data cut-off date of November 14, 51 evaluable patients were enrolled in the gynecologic cancer expansion cohort of the MYTHIC trial.
Across all tumor types treated at the optimized RP2D (n=67), Lunre+Camo therapy showed a favorable and differentiated tolerability profile compared to current and emerging therapies.
The most common adverse event was anemia (26.9%, Grade 3).
Key Cohort Clinical Findings
Key efficacy outcomes from 27 evaluable patients with endometrial cancer show:
- Overall response rate was 25.9% (confirmed ORR in 5 out of 7 patients).
- Clinical benefit was observed in 48.1% of patients, with responses frequently occurring after 12 weeks or more.
- At the 24-week landmark analysis, nearly half of patients experienced durable clinical benefit (24-week PFS [PFS24w] = 43%.
Key efficacy outcomes in 24 evaluable Platinum-Resistant Ovarian Cancer patients show:
- Overall response rate was 37.5% (confirmed ORR in 4 out of 9 patients).
- Clinical benefit was observed in 79% of patients.
- PFS at the 24-week landmark analysis was PFS24w = 45%.
Repare has consulted with the FDA and the European Medicines Agency, who have guided the company's registrational development plans for Lunre+Camo in gynecologic tumors.
Repare plans to provide the final Phase 3 trial protocols for regulatory clearance imminently and intends to start the first Phase 3 Lunre+Camo trial in endometrial cancer in the second half of 2025.
Additionally, the company expects to initiate a small contribution of components trial in up to 40 patients with endometrial cancer in the first quarter of 2025.
Price Action: RPTX stock is down 52.4% at $1.89 at last check Friday.
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