Roche Ends Agreement With Repare Therapeutics to Develop ATR Inhibitor Camonsertib

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Roche has halted its worldwide license and collaboration agreement with Repare Therapeutics Inc. to develop and commercialize camonsertib (RP-3500). The rights to camonsertib, an oral small molecule Ataxia-Telangiectasia and Rad3-related (ATR) protein kinase inhibitor, now revert back to Repare, who plan to continue development of the agent across tumor types.¹

“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,” Repare President and CEO Lloyd M. Segal, said in a press release. “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.”¹

Roche and Repare came to terms on the deal in June 2022, which included a $125 million upfront payment and could have reached up to $1.2 billion based on clinical, regulatory, commercial, and sales milestones.² Camonsertib is in development across numerous solid tumors both as a monotherapy and for potential use in combination therapies. Data had shown camonsertib could be a potential best-in-class ATR inhibitor with a promising safety profile for cancers with high unmet medical needs.²

“Roche is excited about the emerging DNA damage response field, which represents a promising new approach to precision oncology," Roche Global Head of Pharma Partnering James Sabry, MD, PhD, said in a June 2022 news release. “We are looking forward to partnering with Repare Therapeutics to further develop camonsertib as a new potential treatment option for patients with significant unmet medical needs across a range of tumor types. The collaboration with Repare builds on Roche’s strategy of personalized healthcare and further strengthens our leadership in oncology.”²

Last month, Repare announced it achieved a $40 million milestone payment after the first patient was dosed with camonsertib in the global, multicenter, open-label, multi-cohort Phase II TAPISTRY trial (NCT04589845).³ The trial investigators sought to analyze the safety and efficacy of targeted therapies or immunotherapy in patients with unresectable, locally advanced or metastatic solid tumors found to harbor specific oncogenic genomic alterations.

In October 2023, Roche enrolled the first patient in the Phase Ib/II Morpheus Lung (NCT03337698) clinical trial of camonsertib to evaluate multiple immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer. Repare also announced it was performing tumor-specific expansions in the ATTACC trial to support further development of camonsertib combined with PARP inhibitors.³

“This milestone is a key achievement for us, demonstrating Roche’s commitment to the global clinical development of camonsertib and highlighting their exploration of development opportunities for camonsertib across multiple tumor types and genetic alterations to maximize patient impact,” Segal said on January 25, 2024.³

Just a few weeks later, Roche communicated that as of May 7, 2024, the agreement for the development and commercialization of camonsertib was terminated, “following a review of Roche’s pipeline and evolving external factors.”¹

Repare noted that a Phase I trial of camonsertib plus lunresertib is ongoing in patients with molecularly selected, advanced solid tumors. The combination produced a 33.3% overall response rate across all tumor types and 50% RECIST objective response among individuals with heavily pre-treated gynecologic tumors. Additional data for the camonsertib plus lunresertib combination will be presented in the second half of 2024.

“Repare 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,” the company stated in the release.¹

References

1. Repare Therapeutics to Regain Global Rights to Camonsertib. Repare Therapeutics. News release. February 12, 2024. Accessed February 13, 2024. https://www.businesswire.com/news/home/20240212526076/en/Repare-Therapeutics-to-Regain-Global-Rights-to-Camonsertib

2. Repare Therapeutics Announces a Worldwide License and Collaboration Agreement with Roche for Camonsertib (RP-3500). Repare Therapeutics. News release. June 11, 2022. Accessed February 13, 2024. https://ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-announces-worldwide-license-and

3. Repare Therapeutics Announces Achievement of $40 Million Roche Clinical Milestone Payment. Repare Therapeutics. News release. January 25, 2024. Accessed February 13, 2024