This section highlights FDA-related milestones and regulatory updates for drugs developed by Repare Therapeutics (RPTX).
Over the past two years, Repare Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Camonsertib and lunresertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Camonsertib - FDA Regulatory Timeline and Events
Camonsertib is a drug developed by Repare Therapeutics for the following indication: In patients (pts) with advanced cancers harboring ATM loss-of-function (LoF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Camonsertib
- Announced Date:
- April 25, 2025
- Indication:
- In patients (pts) with advanced cancers harboring ATM loss-of-function (LoF)
Announcement
Repare Therapeutics Inc announced the acceptance of two abstracts for mini-oral presentation and the acceptance of four abstracts for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
AI Summary
Repare Therapeutics Inc. announced that its research abstracts have been accepted for presentation at the American Association for Cancer Research Annual Meeting in Chicago, Illinois, from April 25-30, 2025. The company will showcase two mini-oral presentations and four poster presentations. The mini-oral sessions include one study on combining the PKMYT1 inhibitor lunresertib with the ATR inhibitor camonsertib in ovarian and endometrial cancers, and another focusing on the PLK4 inhibitor RP-1664’s potential in preclinical neuroblastoma models.
The poster presentations will cover diverse research areas, including PLK4 inhibition sensitivity in neuroblastoma, tumor regression in TRIM37-high models, a pan-cancer analysis of TRIM37 copy-number, and targeting CCNE1 amplification in gastric cancer. These presentations underscore Repare’s commitment to advancing precision oncology and developing innovative cancer therapies.
Read Announcement- Drug:
- Camonsertib
- Announced Date:
- September 30, 2024
- Indication:
- In patients (pts) with advanced cancers harboring ATM loss-of-function (LoF)
Announcement
Repare Therapeutics Inc reported data highlighting the clinical benefits of camonsertib, a potential best-in-class oral small molecule ATR inhibitor, combined with palliative radiation for the treatment of metastatic tumors harboring an ataxia-telangiectasia-mutated (ATM) mutation.
AI Summary
Repare Therapeutics Inc. reported promising Phase 1 data for camonsertib, a potential best-in-class oral ATR inhibitor, when used together with palliative radiation. The study focused on patients with metastatic tumors that have an ataxia-telangiectasia-mutated (ATM) mutation. Data from the trial, conducted in collaboration with Memorial-Sloan Kettering Cancer Center, showed that the combination treatment may effectively radiosensitize tumors. Early results indicated that patients with pathogenic ATM mutations had better clinical responses, including complete and partial responses, compared to those with variants of unknown significance. The trial included 17 patients with various cancer types, such as gastrointestinal, pancreas, breast, lung, bladder, and thyroid cancers. These encouraging findings support the potential of camonsertib to improve outcomes and highlight its promise as an important new treatment in precision oncology.
Read Announcement- Drug:
- Camonsertib
- Announced Date:
- September 13, 2024
- Indication:
- In patients (pts) with advanced cancers harboring ATM loss-of-function (LoF)
Announcement
Repare Therapeutics Inc. announced the Company will share new data from Module 1 of its ongoing Phase 1/2 TRESR clinical trial during an oral presentation on September 14 at the European Society for Medical Oncology Congress (ESMO), held in Barcelona, Spain.
AI Summary
Repare Therapeutics Inc. announced that it will share new data from Module 1 of its ongoing Phase 1/2 TRESR clinical trial during an oral presentation at the European Society for Medical Oncology Congress (ESMO) in Barcelona, Spain. The trial, which is designed as a first-in-human, multi-center, open-label study, evaluates camonsertib monotherapy in patients with solid tumors. This study aims to identify the recommended Phase 2 dose and schedule by examining safety, pharmacokinetics, and preliminary anti-tumor activity. The presentation, titled "Camonsertib (cam) monotherapy in patients with advanced cancers harboring ATM loss-of-function (LoF)," will be delivered by Dr. Benedito A. Carneiro from the Legorreta Cancer Center at The Warren Alpert Medical School. The session is scheduled for September 14 during the Mini Oral Session on Developmental Therapeutics.
Read Announcement
lunresertib - FDA Regulatory Timeline and Events
lunresertib is a drug developed by Repare Therapeutics for the following indication: Oral inhibitor of ATR.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- lunresertib
- Announced Date:
- June 26, 2024
- Indication:
- Oral inhibitor of ATR,
Announcement
Repare Therapeutics Inc reported positive initial data from the ongoing Phase 1 MINOTAUR clinical trial evaluating lunresertib (RP-6306) in combination with FOLFIRI in patients with advanced solid tumors.
AI Summary
Repare Therapeutics Inc. recently reported positive initial data from its ongoing Phase 1 MINOTAUR clinical trial. The study is evaluating lunresertib (RP-6306) in combination with standard FOLFIRI in patients with advanced solid tumors who have specific genomic alterations, such as CCNE1 amplification and FBXW7 mutations. These patients usually face poor prognosis and limited treatment options.
The early results showed an overall response rate of 18.2% in a heavily pretreated population, regardless of previous irinotecan exposure. Moreover, the trial established a preliminary recommended Phase 2 dose of 60mg BID of lunresertib when given continuously with FOLFIRI. Encouraging signs include prolonged clinical benefits in colorectal cancer patients, particularly among those who had not received irinotecan before, with some patients remaining on treatment for over nine months. The combination also demonstrated a safety profile similar to that of FOLFIRI alone, supporting further clinical development.
Read Announcement
