Allogene Concedes to BMS in Leukemia Battle, Halting Phase I CAR T Patient Enrollment

Allogene Concedes to BMS in Leukemia Battle, Halting Phase I CAR T Patient Enrollment

Allogene Concedes to BMS in Leukemia Battle, Halting Phase I CAR T Patient Enrollment

In a recent announcement, Allogene has decided to halt patient enrollment in a Phase I trial concerning a CAR T cell therapy aimed at treating an advanced type of leukemia, responding to escalating competition from Bristol Myers Squibb’s Breyanzi. This update was disclosed in a regulatory filing released on Wednesday evening.

The company had been involved in the ALPHA2 trial, focusing on cema-cel for patients suffering from relapsed or refractory chronic lymphocytic leukemia. However, the company indicates that enrollment has slowed significantly due to “the emergence of new alternative treatment options,” as detailed in the SEC filing.

Among these alternatives is the CD19 CAR T therapy, Breyanzi, which received FDA approval for this specific indication back in March, building upon its earlier approval for relapsed or refractory large B cell lymphoma in February 2021. In the third quarter, BMS reported 4 million in global sales of the cell therapy, which was more than double its revenue from Q3 2023, fueled by the new leukemia indication as well as the approval for mantle cell lymphoma granted in May.

Analysts from William Blair found the decision unsurprising, noting that Allogene had not addressed the leukemia program in its latest earnings report and had previously postponed an initial data readout. The analysts pointed out that this patient demographic is rather limited, with an estimated 40,000 individuals, and therefore, it is not expected to have significant repercussions for Allogene.

The firm suggested that Allogene’s resources would be better allocated to other areas. Although Allogene did not disclose specifics on where it plans to shift its focus, analysts identified large B cell lymphoma as a potentially more advantageous target 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,” the analysts noted.

Additionally, Allogene is venturing into autoimmune diseases through its CAR T therapies, inspired by emerging research indicating that cell therapy might aid in achieving remission in conditions such as lupus.