Relay Therapeutics and Elevar Therapeutics have announced an exclusive global licensing agreement for lirafugratinib (RLY-4008), a selective oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2). This agreement aims to advance the treatment of FGFR2-driven cholangiocarcinoma (CCA) and other FGFR2-altered solid tumors. Under the terms, Elevar will receive worldwide development and commercialization rights, while Relay is eligible to receive up to $500 million in payments, including $75 million upfront and in regulatory milestones, plus tiered royalties on global sales.
Regulatory and Clinical Standing
The FDA has granted lirafugratinib breakthrough therapy and orphan drug designations. Following a meeting with the FDA, Relay Therapeutics plans to initially file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for other FGFR2-altered solid tumors. This regulatory pathway is supported by data from the global ReFocus trial, which includes a pivotal cohort in patients with FGFR2-fusion CCA designed to support accelerated approval.
Strategic Implications for Relay Therapeutics
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics, stated that the agreement allows Relay to focus on advancing its PI3Kα programs, including initiating the RLY-2608 2L breast cancer pivotal trial and vascular malformations trial next year. The deal enables Relay to monetize lirafugratinib while concentrating resources on other core programs.
Elevar's Perspective and Plans
Saeho Chong, Ph.D., chief executive officer of Elevar Therapeutics, highlighted lirafugratinib as an NDA-ready therapy with a potential best-in-class profile in both FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors. Elevar aims to diversify and expand its late-stage oncology pipeline with lirafugratinib, aligning with its mission of delivering life-changing medicines to cancer patients globally.
Lirafugratinib's Clinical Potential
Lirafugratinib is currently being investigated in the global ReFocus trial in patients with FGFR2-altered tumors. Interim data from the pivotal cohort in patients with FGFR2-fusion CCA were presented at the European Society for Medical Oncology Congress in 2022. The study also includes cohorts in patients with other types of solid tumors, including gastric, pancreatic, and head and neck tumors. Interim data from these cohorts were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in 2023 and 2024.
Cholangiocarcinoma (CCA) Context
Cholangiocarcinoma, or bile duct cancer, is a rare disease characterized by malignant cells forming in the bile ducts. Approximately 8,000 people in the United States are diagnosed with CCA each year, highlighting the unmet medical need that lirafugratinib aims to address.
Financial Details of the Agreement
Under the agreement, Elevar will assume full responsibility for all further development activities, including submission of the NDAs, all subsequent clinical development, and global commercialization for FGFR2-driven CCA and FGFR2-altered other solid tumors. Relay Therapeutics is eligible to receive up to $75 million in upfront and regulatory milestones, plus up to $425 million in potential commercial milestone payments, as well as tiered royalties up to the low-teens percentage.
