American Society of Clinical Oncology (ASCO) Abstract Reports Initial ALLO-501 ALPHA Phase 1 Data in Relapsed/Refractory Non-Hodgkin Lymphoma
- ALLO-501 in Combination with ALLO-647 Based Lymphodepletion Regimen was Well Tolerated With No Dose-Limiting Toxicities or Evidence of Graft-vs-Host Disease
- Abstract Based on Data Cutoff in
January 2020Represents Limited Data Set of Nine Evaluable Patients Treated at Lower Dose (39mg) ALLO-647; Three Patients Achieved a Complete Response (CR)
- Results from Additional Evaluable Patients Including Those Treated at Higher Dose (90 mg) ALLO-647 Will Be Presented at the Virtual ASCO Meeting on
May 29, 2020
- Allogene Continues Study Enrollment to Optimize Lymphodepletion
“As we look ahead to the end of the month to the virtual ASCO meeting, we are excited to present initial clinical data from our first-in-human study of ALLO-501 and ALLO-647,” said
The ASCO abstract includes preliminary data on the first nine patients treated with escalating doses of ALLO-501 and lower dose (39mg) ALLO-647. No dose limiting toxicities or graft-vs-host disease (GvHD) was observed. The most common Grade (Gr) ≥ 3 adverse events were neutropenia (55.6%), leukopenia (33.3%) and anemia (22.2%). Two patients (22.2%) developed cytokine release syndrome (one Gr1 and one Gr2) that resolved within 72 hours without steroids or tocilizumab. One patient developed Gr1 neurotoxicity that resolved without treatment. One patient developed upper respiratory tract infection (Gr2), CMV (Gr3) and EBV viremia (Gr1), which all resolved. One patient had a Gr2 infusion reaction to ALLO-647 which resolved with antihistamines.
In this limited dataset with a small number of patients, the overall response rate (ORR) was 78% (95% exact CI: 40%, 97%) with three complete responses (CR) and four partial responses (PR). As of the
The virtual presentation will include data on 11 patients across ALLO-501 cell dose cohorts and the lower dose (39mg) of ALLO-647, as well as additional patients treated with ALLO-501 and the higher dose (90mg) of ALLO-647. The Phase 1 ALPHA study continues to enroll patients with higher dose ALLO-647 in an effort to optimize lymphodepletion.
This virtual presentation will be available on demand when ASCO releases pre-recorded presentations on
Oral Abstract Session: Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia
Title: First-in-Human Data of ALLO-501 and ALLO-647 in Relapsed/Refractory Large B-cell or Follicular Lymphoma (R/R LBCL/FL): ALPHA Study.
Presenter: Sattva S. Neelapu, MD,
Session Release Date & Time:
Location: On demand virtual presentation
Allogene is the sponsor of this Phase 1 trial which is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 and ALLO-647 in patients with relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma.
Allogene expects to initiate enrollment in ALPHA2, a Phase 1 trial with abbreviated dose escalation of ALLO-501A, in Q2 2020. ALLO-501A is the next generation of ALLO-501, which eliminates the rituximab recognition domains, and it is intended for Phase 2 development.
About ALLO-501 (Allogene Sponsored)
Allogene’s AlloCAR T programs utilize Cellectis technologies. ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly developed under a collaboration agreement between
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This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress the Phase 1 trial of ALLO-501 and present data, the timing and ability to initiate and progress a clinical trial of ALLO-501A, the ability to manufacture AlloCAR T™ therapies, including ALLO-501A, the ability to develop allogeneic CAR T therapies for cancer and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
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Source: Allogene Therapeutics, Inc.