Relay blames IRA for pause in plans to win approval in rare cancer, adding laps to its race to market

Relay Therapeutics has decided to extend its race to market. Citing the impact of the Inflation Reduction Act (IRA), the biotech has paused plans to bring lirafugratinib to market in a rare cancer, choosing instead to pursue a larger, tumor-agnostic opportunity. 

Boston-based Relay began enrolling patients with FGFR2-fusion cholangiocarcinoma, a rare, aggressive cancer of the bile duct, in a pivotal expansion cohort in December 2021. Enrollment in the cohort is now complete. However, rather than race toward an approval in cholangiocarcinoma while working to validate the drug in larger indications, the biotech has paused preparations to commercialize the asset in the rare cancer.

The shift in strategy follows the generation of data showing lirafugratinib, also known as RLY-4008, may work in cancers other than cholangiocarcinoma. Relay CEO Sanjiv Patel told investors on a call how the data and changes to the commercial environment combined to persuade his team to delay plans to bring lirafugratinib to market.

“We've taken the decision to focus on the larger tumor agnostic opportunity as our first regulatory approval pathway and align the timing of accessing the cholangiocarcinoma opportunity to this,” Patel said.

“The IRA favors accessing larger opportunities initially versus the conventional approach of speed to market with smaller indications,” the CEO added. “This clearly pushes out our investment on commercial readiness.” 

With plans to commercialize lirafugratinib on hold, Relay will focus on validating the drug in all solid tumor patients with FGFR2 fusions and alterations. The biotech estimates 20,000 people in the U.S. are diagnosed with solid tumors that have FGFR2 fusions and alterations each year. Around 1,000 people in the country are diagnosed with FGFR2-fusion cholangiocarcinoma annually.

“Over the next year, we will generate data from the fully enrolled cholangiocarcinoma pivotal cohort and with a limited investment will also follow the tumor agnostic signal and share further data in 2024 and a regulatory update on these cohorts as we determine the optimal path forward to help these patients,” Patel said. 

The early data in solid tumors other than cholangiocarcinoma show response rates of 24% to 40% and durability of six months and more in most responders. Relay will work to generate more data in those cohorts while investing in its PI3Kα mutant selective franchise.

By focusing on those opportunities, and pausing commercialization preparations and a preclinical CDK2 program, Relay calculates the $872 million it had at the end of the second quarter can keep it going into the second half of 2026. The changes have extended Relay’s cash runway by one year.