Repare Therapeutics Inc. announced that, under its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib, it has earned a $40 million milestone payment from Roche upon dosing of the first patient with camonsertib (RP-3500 or RG6526) in Roche’s TAPISTRY trial (NCT04589845). TAPISTRY is a Phase 2, global, multicenter, open-label, multi-cohort clinical trial designed to evaluate the safety and efficacy of targeted therapies or immunotherapy in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations.
In October, Roche also enrolled the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698). The TAPISTRY and MORPHEUS trials are actively enrolling patients. In collaboration with Roche, Repare is continuing to conduct tumor specific expansions in the ATTACC trial to support future clinical development for camonsertib + PARP inhibitor combinations.
“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,” said Lloyd M. Segal, President and Chief Executive Officer of Repare.
Under the terms of its collaboration with Roche, Repare received a $125 million upfront payment in July 2022, as well as $13.6 million in additional payments, and is eligible to receive up to $1.2 billion in potential clinical, regulatory, commercial and sales milestone payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.