US-Canadian clinical-stage precision oncology company, Repare Therapeutics, has unveiled positive data from its Phase I gynecologic expansion trial evaluating Lunre+Camo, a combination of lunresertib and camonsertib, in patients with endometrial cancer and ovarian cancer.
The MYTHIC clinical trial (NCT04855656) found that heavily pretreated patients on Lunre+Camo achieved a 25.9% overall response rate (ORR) for endometrial cancer and 37.5% in platinum-resistant ovarian cancer.
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Additionally, the first-in-human, global, open-label, dose-escalation trial found that nearly half of patients with gynecologic cancers maintained progression-free survival at 24 weeks compared to the current standard of care (SOC). Now the company says it is looking to pursue a registrational Phase III trial of Lunre+Camo in endometrial cancer for the second half of 2025.
Lunresertib is a small molecule PKMYT1 inhibitor that treatment targets cell cycle regulation in tumours. Camonsertib is an oral inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase that selectively targets and inhibits ATR activity and blocks the downstream phosphorylation of the serine/threonine protein kinase checkpoint kinase 1 (CHK1).
Lloyd Segal, president of Repare Therapeutics, said: “We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial.
“These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase III trial of Lunre and Camo in endometrial cancer.”
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By GlobalDataAdditional results from the trial that enrolled 27 endometrial cancer patients and 24 evaluable patients with platinum-resistant ovarian cancer, saw clinical benefit observed in 79% of patients. Now, the company has consulted with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which provided guidance for Repare’s registrational development plans for Lunre+Camo in gynecologic tumours.
Maria Koehler, chief medical officer of Repare said: “The results of the MYTHIC clinical trial increase our confidence in the potential to bring Lunre+Camo to patients living with this aggressive subset of recurrent endometrial cancer.
“We are deeply grateful to the patients and investigators who participated in this trial, and we look forward to building on these promising data through the registrational clinical trials using Lunre+Camo as a potential new standard of care for those patients if approved.”
The news comes after Repare Therapeutics dosed the first subject in its Phase I POLAR clinical trial of RP-3467, a Polθ ATPase inhibitor, as a potential treatment for various solid tumours. It also follows after the company announced plans to slash its workforce by 25% as part of re-prioritisation efforts.
