Relay Therapeutics is altering its strategic course, driven by the effects of the Inflation Reduction Act (IRA), leading the biotech to pause its plans to bring the cancer drug lirafugratinib to market for a rare cancer. Instead, Relay has chosen to pursue a broader, tumor-agnostic opportunity.
The Boston-based company initially initiated enrollment of patients with FGFR2-fusion cholangiocarcinoma, a rare and aggressive bile duct cancer, in a pivotal expansion cohort in December 2021. However, rather than pushing for approval in cholangiocarcinoma while validating the drug in larger indications, Relay has opted to delay its commercialization efforts for the rare cancer.
This strategic shift is based on data suggesting that lirafugratinib, also known as RLY-4008, may have applications beyond cholangiocarcinoma. Relay’s CEO, Sanjiv Patel, explained that the data, along with changes in the commercial landscape, influenced the decision to delay the drug’s market entry.
With commercialization plans on hold, Relay will now focus on validating lirafugratinib in all solid tumor patients with FGFR2 fusions and alterations. The biotech estimates that approximately 20,000 people in the US are diagnosed with solid tumors featuring FGFR2 fusions and alterations each year, compared to around 1,000 diagnosed with FGFR2-fusion cholangiocarcinoma annually.
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“These data provide important early evidence that RLY-4008, or lirafugratinib, has the potential to help both patients with FGFR2-fusion cholangiocarcinoma as previously reported, as well as those with multiple other types of FGFR2-altered tumors. We are excited by the potential for lirafugratinib to help many more patients and are focused on advancing this opportunity as well as our PI3Kα programs, with the initiation of a RLY-2608 triplet combination trial this year.”
– Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics
Early data in solid tumors other than cholangiocarcinoma has shown response rates ranging from 24% to 40% with a durability of six months or more in most responders. Relay aims to generate more data in these cohorts while also investing in its PI3Kα mutant selective franchise.
By concentrating on these opportunities and temporarily suspending commercialization efforts and a preclinical CDK2 program, Relay anticipates that the $872 million it had at the end of the second quarter will sustain its operations until the second half of 2026. These strategic changes have extended Relay’s cash runway by one year.
