Allogene Therapeutics' Allogeneic CAR-T Therapy Proves Potential for LBCL Treatment, Analysts See Potential for First-in-Class Status

Thursday, Allogene Therapeutics Inc ALLO presented the updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in 33 CAR T naïve patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) treated with the Alloy manufacturing process material across different CAR T dosing and lymphodepletion regimens. 

Seven of 12 (58%) patients receiving the Phase 2 regimen achieved a CR, and five (42%) maintained a CR through Month 6. 

Of the five patients who were in CR at six months, four (80%) remained in CR. 

The fifth patient had disease progression at 24 months. The median duration of response was 23.1 months, with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months. 

Across all 33 patients, the CR rate was 42%, with 30% maintaining a CR at Month 6. 

These results indicate that complete responses are more common with lymphodepletion regimens containing 90 mg of ALLO-647 (FCA90). The median response duration for the overall population (n=33) and the patients treated with the Phase 2 regimen (n=12) was 23.1 months.

William Blair writes that the updated durability data, coupled with the minimal time from enrollment to dosing (median three days), supports the potential therapeutic benefit of ALLO-501A as a first-in-class and best-in-class allogeneic CD19 CAR-T therapy. 

In addition, it says that the data supports the company’s initiative to pursue the FCA90 regimen.

Canaccord Genuity says the ALLOY process showed continued efficacy improvement vs. the original process. The analyst expects positive pivotal ALPHA2 data by YE24 after completing the enrollment planned for 1H24.

Price Action: ALLO shares are down 2.21% at $4.86 on the last check Friday.