Relay Therapeutics

RLY-2608, an oral, mutant-selective PI3Kα allosteric inhibitor, addresses off-target toxicities of current modulators, currently in Ph. I for HR+/HER2- breast cancer treatment.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.

The ZEST trial, aiming to evaluate niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed to accrue enough eligible patients. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Only 40 patients were enrolled, with insufficient data to assess niraparib efficacy.

The ZEST trial failed to enroll enough ctDNA-positive patients for niraparib to prevent breast cancer recurrence. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Only 40 patients were enrolled, with niraparib showing a median recurrence-free interval of 11.4 months vs. 5.4 for placebo.

Relay Therapeutics to present updated clinical data for RLY-2608 + fulvestrant in PI3Kα-mutated, HR+, HER2- breast cancer at the San Antonio Breast Cancer Symposium on Dec 11, 2024. RLY-2608, a mutant-selective PI3Kα inhibitor, aims to treat over 300,000 patients annually in the U.S.

Relay Therapeutics and Elevar Therapeutics announce global licensing agreement for lirafugratinib, a selective FGFR2 inhibitor for FGFR2-driven cholangiocarcinoma and other solid tumors. Elevar assumes development and commercialization, with Relay eligible for $75M in milestones and royalties.

Relay Therapeutics and Elevar Therapeutics announce global licensing agreement for lirafugratinib, a selective oral FGFR2 inhibitor for FGFR2-driven cholangiocarcinoma and other solid tumors. The agreement follows positive FDA interactions and differentiated data. Elevar assumes full development and commercialization responsibilities, with Relay eligible for up to $500 million in milestones and royalties.

Relay Therapeutics and Elevar Therapeutics announce a global licensing agreement for lirafugratinib (RLY-4008), a potential best-in-class FGFR2 inhibitor for FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors. Elevar will assume full development and commercialization responsibilities, with Relay eligible for up to $500 million in milestone payments and royalties.

Relay Therapeutics and Elevar Therapeutics announce exclusive global licensing agreement for lirafugratinib, a potential best-in-class FGFR2 inhibitor for FGFR2-driven cholangiocarcinoma and other solid tumors. Elevar receives worldwide development and commercialization rights, while Relay can earn up to $500 million in payments, including $75 million upfront and regulatory milestones, plus double-digit royalties on global sales. The FDA has granted lirafugratinib breakthrough therapy and orphan drug designations, recommending an NDA for FGFR2-driven CCA first, followed by a supplemental NDA for other solid tumors.