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Allogene's CAR T-Cell Therapy Shows Promising Results in Large B-Cell Lymphoma Trials

• Phase 1 ALPHA and ALPHA2 trials demonstrate cemacabtagene ansegedleucel achieves 67% overall response rate and 58% complete response rate in relapsed/refractory LBCL patients using the selected Phase 2 regimen.

• The therapy shows a manageable safety profile with no graft-versus-host disease or high-grade cytokine release syndrome, comparable to approved autologous CAR T-cell treatments.

• Treatment initiation time of two days represents significant improvement over traditional autologous CAR T-cell therapies, which typically require over one month wait time.

In a significant advancement for cell therapy treatment, Allogene Therapeutics has published promising results from its Phase 1 ALPHA and ALPHA2 clinical trials evaluating cemacabtagene ansegedleucel (cema-cel) in patients with relapsed/refractory large B-cell lymphoma (LBCL). The findings, published as a Rapid Communication in the Journal of Clinical Oncology, represent the largest dataset for allogeneic CAR T treatment in LBCL patients with the longest follow-up period to date.

Clinical Efficacy and Patient Outcomes

The multicenter, open-label trials enrolled 87 heavily pretreated patients with relapsed/refractory non-Hodgkin lymphoma between May 2019 and September 2022. Among these, 33 CD19 CAR T-naive patients with R/R LBCL received cema-cel manufactured using the process selected for pivotal studies.
The selected Phase 2 regimen demonstrated remarkable efficacy:
  • Overall response rate (ORR): 67%
  • Complete response (CR) rate: 58%
  • Median duration of response: 23.1 months
  • Median overall survival: Not reached
Patients achieving complete response showed particularly encouraging outcomes, with a median duration of response of 23.1 months, progression-free survival of 24 months, and overall survival not yet reached.

Safety Profile and Treatment Administration

The therapy demonstrated a manageable safety profile consistent with approved autologous CD19 CAR T cell therapies. Notable safety findings include:
  • No dose-limiting toxicities
  • Absence of graft-versus-host disease
  • No immune effector cell-associated neurotoxicity syndrome
  • No high-grade cytokine release syndrome
Common treatment-emergent adverse events included:
  • Hematological effects: neutropenia, anemia, thrombocytopenia
  • Constitutional symptoms: fatigue, pyrexia
  • Gastrointestinal: nausea
  • Other: infusion-related reactions, hypotension, peripheral edema

Revolutionary Treatment Timeline

A standout feature of the therapy is its rapid treatment initiation, with a median time to start of just two days from study enrollment. This represents a significant improvement over conventional autologous CAR T cell products, which typically require wait times exceeding one month despite recent manufacturing and supply chain improvements.

Clinical Implications

These results suggest that cemacabtagene ansegedleucel could offer a more accessible and equally effective alternative to current autologous CAR T cell therapies. The combination of comparable efficacy, manageable safety profile, and dramatically reduced wait times positions this therapy as a potentially transformative option for LBCL patients requiring urgent treatment.
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