Allogene Therapeutics has dropped plans to target one of its allogeneic CAR-Ts at leukemia in the face of competition from the likes of Bristol Myers Squibb.
The biotech had been enrolling patients in a phase 1 trial of a CD19 CAR-T cell therapy called cemacabtagene ansegedleucel—cema-cel for short—for relapsed or refractory chronic lymphocytic leukemia (CLL) in patients previously treated with BTKi and BCL2i therapies.
“While there is an ongoing need for additional treatment options for these patients, and interest in this cohort remains high among investigators, enrollment in the trial has been slower than anticipated due in part to the emergence of new alternative treatment options,” the company explained in a filing with the Securities and Exchange Commission.
“Consequently, the company is discontinuing enrollment in this trial and reallocating resources to other programs,” Allogene added.
While the biotech didn’t name-check the specific competitors that it blamed for soaking up the pool of potential patients, analysts at William Blair pointed to the additional approval in March of BMS’ own CD19 CAR-T Breyanzi for CLL as one culprit.
Breyanzi became the first CAR-T to enter the CLL field, where BTK inhibitors are standard first-line treatments. To be eligible to receive Breyanzi for CLL, a patient must have tried a BTK drug such as Brukinsa and a BCL2 inhibitor such as AbbVie and Roche’s Venclexta.
Eli Lilly got its own BTK inhibitor Jaypirca approved in December 2023 for CLL patients who have already tried another BTK inhibitor and a BCL-2 inhibitor.
Allogene will now focus cema-cel in large B-cell lymphoma (LBCL), where it is already undergoing a phase 2 trial. The biotech’s pipeline also includes a CD70-targeting CAR-T called ALLO-316 that recently showed success in a phase 1 renal cell carcinoma trial as well as a CD19/CD70 dual CAR-T called ALLO-329 in preclinical development for autoimmune disease.
“While we view the discontinuation of the CLL program as unfortunate, we were not surprised by the announcement given the timing for initial data had been delayed and the program was not mentioned in the company’s most recent earnings release,” William Blair analysts said in a Nov. 14 note.
“We see it as prudent that the company focuses its current cash resources ($403.4 million as of Sept. 30) on the advancement of cema-cel as a first-line consolidation therapy in LBCL, ALLO-316 in RCC, and ALLO-329 in autoimmune diseases,” they added. “In LBCL, we believe cema-cel has the potential to leapfrog other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer, and expand the total addressable market.”