Lyell needs to beat Breyanzi and Yescarta

In third-line large B-cell lymphoma Lyell hopes that an uncontrolled trial will support US approval of its CD19 x CD20 Car-T rondecabtagene autoleucel, but in the second line the project will be going up against established CD19-targeting Car-T therapies. On Wednesday Lyell disclosed that its pivotal second-line study, Pinacle-H2H, will compare ronde-cel against investigator’s choice of Bristol Myers Squibb’s Breyanzi or Gilead’s Yescarta, with a primary endpoint of event-free survival. The first of a total 400 patients is to be enrolled by early 2026. Lyell believes that, by targeting both CD19 and CD20, ronde-cel could produce more complete responses and improve durability versus conventional anti-CD19 Car-Ts, by delaying time to relapse through CD19 antigen escape. In phase 1/2, the ImmPACT Bio-originated ronde-cel (previously LYL314) produced an ORR of 88% and a complete response rate of 72% in third-line LBCL. Lyell cited corresponding figures of around 70% and 50% for both Breyanzi and Yescarta – and now needs to show that its project has the edge in a randomised setting. Others developing CD19 x CD20 Car-Ts include Johnson & Johnson, with the AbelZeta-originated prizloncabtagene autoleucel (JNJ-90014496), and Gilead, with KITE-363 – both of which have shown similar data to ronde-cel.

Notable trials of rondecabtagene autoleucel

Source: OncologyPipeline.