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Repare Therapeutics said Tuesday it regained full worldwide rights to camonsertib (RP-3500) from Roche, effective May 7. The deal termination, which comes just weeks after a milestone payment, was triggered by a review of the pharma’s pipeline and unnamed “external factors.” The news shaved about 16% off Repare’s share price Tuesday. The precision oncology company, which uses a synthetic lethality approach to develop cancer therapeutics, last month scored a $40-million milestone payment after Roche dosed the first patient with camonsertib in the Phase II TAPISTRY trial. The study is enrolling patients with solid tumours to receive one of 11 different therapies based on their specific oncogenic genomic alterations. According to ClincalTrials.gov, patients are eligible to receive camonsertib if their cancer exhibits a SETD2 or ATM loss of function mutation. Roche had gained rights to camonsertib in a 2022 deal that saw it shell out $125 million upfront. Along with the TAPISTRY payment, Repare had received another $13.6 million in milestones; the company had been eligible for up to $1.2 billion in total. Clinical combos for cancerIn addition to TAPISTRY, the oral ATR inhibitor is being tested in one other trial sponsored by Roche, and at least two separate studies from Repare.“We have been continuously running clinical trials for camonsertib since July 2020 and are excited to steward the progress of this promising therapy,” CEO Lloyd Segal said in a statement. “While we are disappointed to end this collaboration, we appreciate the contributions Roche has made to the programme.”Roche is running the Phase I/II MORPHEUS trial in patients with metastatic non-small-cell lung cancer, which is testing camonsertib in combination with PD-L1 inhibitor Tecentriq (atezolizumab) and anti-VEGF antibody Avastin (bevacizumab). Repare’s Phase 1 MYTHIC trial is evaluating camonsertib in combination with another programme in its pipeline: lunresertib, an oral small molecule inhibitor of PKMYT1. The trial is enrolling patients with advanced, recurrent tumours with detected CCNE1 amplification, or deleterious alterations in FBXW7 and other STEP2 genes.Additionally, Repare is testing camonsertib with PARP inhibitors to treat solid tumours in the Phase I/II ATTACC trial.

Repare has said that it will take back control its global development and commercialization rights to camonsertib (RP-3500), it says is a potential best-in-class, oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase). Roche notified Repare that, effective from May 7, 2024, it is terminating its agreement for the development of camonsertib following a review of Roche’s pipeline and evolving external factors. Repare regains full control of all. “Camonsertib is a valuable, high-potential precision oncology medicine that has achieved clinical proof-of-concept in multiple tumor types and genotypes both as monotherapy and in combination, as previously reported. We have been continuously running clinical trials for camonsertib since July 2020 and are excited to steward the progress of this promising therapy,” said Lloyd M. Segal, president and chief executive officer of Repare. “While we are disappointed to end this collaboration, we appreciate the contributions Roche has made to the program. With the return of camonsertib, Repare’s deep clinical pipeline consists of four wholly owned synthetic lethal therapies.” Roche said its decision to stop further development of camonsertib and terminate our partnership with Repare is driven by two main factors including 'evolving external factors including the regulatory and competitive landscape in the indications of interest' have changed its original investment thesis of camonsertib. A spokesperson for Roche said: "Over the past months, we have established a new evaluative framework to prioritise pipeline assets and focus our resources. The prioritisation of our pipeline assets and resources can require decisions to stop or terminate R&D programmes or partnerships. These decisions are never taken easily. The termination has no implications for other ongoing studies or indications. googletag.cmd.push(function () { googletag.display('text-ad1'); }); "Roche’s ambition remains to lead the cure for cancer. We are focusing on developing medicines across various types of solid tumours and haematological malignancies. Our treatment approaches are broad and include targeted therapies, cancer immunotherapies, cell and gene therapies as well as next-generation vaccines. We remain committed to the investigation of DNA Damage Response (DDR), which is a fast-moving and growing space." Camonsertib is also part of Repare’s ongoing phase 1 MYTHIC trial evaluating the combination of camonsertib and lunresertib, a first-in-class, oral small molecule inhibitor of PKMYT1, in patients with molecularly selected, advanced solid tumors. In October 2023, the company presented data on the camonsertib and lunresertib combination, demonstrating clear evidence of clinical benefit across multiple tumor types and all selected genotypes, with an overall response of 33.3% across all tumor types and 50% Recist objective response in patients with heavily pre-treated gynecologic tumors at the preliminary recommended phase 2 dose of the combination. Repare says it expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024. ​ It says it has met all obligations under the Roche agreement to date and recently earned a $40 million milestone payment from Roche. Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026. Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics.

Repare has said that it will take back control its global development and commercialization rights to camonsertib (RP-3500), it says is a potential best-in-class, oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase). Roche notified Repare that, effective from May 7, 2024, it is terminating its agreement for the development of camonsertib following a review of Roche’s pipeline and evolving external factors. Repare regains full control of all. “Camonsertib is a valuable, high-potential precision oncology medicine that has achieved clinical proof-of-concept in multiple tumor types and genotypes both as monotherapy and in combination, as previously reported. We have been continuously running clinical trials for camonsertib since July 2020 and are excited to steward the progress of this promising therapy,” said Lloyd M. Segal, president and chief executive officer of Repare. “While we are disappointed to end this collaboration, we appreciate the contributions Roche has made to the program. With the return of camonsertib, Repare’s deep clinical pipeline consists of four wholly owned synthetic lethal therapies.” Roche said its decision to stop further development of camonsertib and terminate our partnership with Repare is driven by two main factors including 'evolving external factors including the regulatory and competitive landscape in the indications of interest' have changed its original investment thesis of camonsertib. A spokesperson for Roche said: "Over the past months, we have established a new evaluative framework to prioritise pipeline assets and focus our resources. The prioritisation of our pipeline assets and resources can require decisions to stop or terminate R&D programmes or partnerships. These decisions are never taken easily. The termination has no implications for other ongoing studies or indications. googletag.cmd.push(function () { googletag.display('text-ad1'); }); "Roche’s ambition remains to lead the cure for cancer. We are focusing on developing medicines across various types of solid tumours and haematological malignancies. Our treatment approaches are broad and include targeted therapies, cancer immunotherapies, cell and gene therapies as well as next-generation vaccines. We remain committed to the investigation of DNA Damage Response (DDR), which is a fast-moving and growing space." Camonsertib is also part of Repare’s ongoing phase 1 MYTHIC trial evaluating the combination of camonsertib and lunresertib, a first-in-class, oral small molecule inhibitor of PKMYT1, in patients with molecularly selected, advanced solid tumors. In October 2023, the company presented data on the camonsertib and lunresertib combination, demonstrating clear evidence of clinical benefit across multiple tumor types and all selected genotypes, with an overall response of 33.3% across all tumor types and 50% Recist objective response in patients with heavily pre-treated gynecologic tumors at the preliminary recommended phase 2 dose of the combination. Repare says it expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024. ​ It says it has met all obligations under the Roche agreement to date and recently earned a $40 million milestone payment from Roche. Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026. Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics.