Allogene Halts Leukemia CAR-T Trial Enrollment Due to Breyanzi Competition

Allogene Discontinues Enrollment:
Allogene has stopped enrolling patients in its Phase I trial for cema-cel, a CAR-T cell therapy, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) due to competitive pressures from Bristol Myers Squibb's Breyanzi1.

Breyanzi Approval Impact:
Breyanzi, an autologous CD19 CAR-T therapy, was approved for CLL in March 2024, leading to a slowdown in enrollment for Allogene's ALPHA2 trial15.

Shift in Strategy:
Allogene is redirecting its efforts, focusing on large B-cell lymphoma (LBCL) where cema-cel could potentially leapfrog other autologous and allogeneic CD19 CAR-T therapies and expand the total addressable market12.

New Trial Plans:
Allogene plans to start a new study, ALPHA3, testing cema-cel in LBCL patients at risk of relapse after R-CHOP treatment, aiming to boost cure rates and demonstrate the potential for off-the-shelf treatments in community cancer practices24.

Exploration into Autoimmune Diseases:
Allogene is also expanding into autoimmune diseases, such as lupus, with its CAR-T therapies, exploring the potential for cell therapy to induce remission without standard chemotherapy preconditioning24.

Sources:

1. https://www.biospace.com/business/allogene-bows-to-bms-in-leukemia-ending-phase-i-car-t-enrollment

2. https://www.biopharmadive.com/news/allogene-restructuring-strategy-car-t-lymphoma-trial/703643/

4. https://www.oncologypipeline.com/apexonco/two-allogeneic-cell-therapy-switches-day

5. https://www.oncologypipeline.com/apexonco/new-breyanzi-approval-comes-timely-moment-allogene