Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.
Allogene is bowing to competitive pressures from Bristol Myers Squibb’s Breyanzi and discontinuing enrollment in a Phase I trial for a CAR T cell therapy in an advanced form of leukemia, the company announced in a regulatory filing Wednesday evening.
Allogene had been enrolling patients in the early-stage ALPHA2 trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia. But the biotech is cutting the study as enrollment has slowed following “the emergence of new alternative treatment options,” Allogene said in the SEC filing.
The new option is CD19 CAR T Breyanzi, which was approved for the indication in March, after originally being approved for relapsed or refractory large B cell lymphoma in February 2021. BMS clocked $224 million in worldwide sales for the cell therapy in the third quarter, more than double Q3 2023 thanks to its new leukemia indication as well as mantle cell lymphoma, for which the cell therapy was approved in May.
William Blair’s analysts were not surprised by the decision, as Allogene had not mentioned the leukemia program in its recent earnings release and had already delayed an initial data readout. It’s also a fairly small population with about 40,000 patients, so the firm is unconcerned about impacts to Allogene.
The resources are better directed elsewhere, William Blair noted. While Allogene did not specify where it will redirect its efforts, the analysts pointed to large B cell lymphoma as a better focus for cema-cel.
“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,” William Blair wrote.
Allogene is also expanding into autoimmune disease with its CAR T therapies, following emerging science that suggests cell therapy could help bring on remission in conditions like lupus.
