Allogene Therapeutics Announces Oral Presentation of Initial Results from its Phase 1 Dose Escalation Study of ALLO-715 in Relapsed/Refractory Multiple Myeloma at the 62nd Annual Meeting of the American Society of Hematology
- ALLO-715, an Allogeneic BCMA CAR T Therapy Dosed with an ALLO-647 Based Lymphodepletion Regimen, Reported No Neurotoxicity or GvHD Across Three Cell Doses (40M, 160M, and 320M CAR+ cells) and
Lower Dose(39mg) ALLO-647
- Dose Dependent Activity Was Observed with 320M Cell Dose of ALLO-715 (DL3) Associated with a 60% Overall Response Rate (ORR)
- All DL3 Patients with a VGPR or Greater Achieved MRD Negative Status
- Results from Additional Patients, Including Patients Treated at Higher Doses of ALLO-715 and ALLO-647 Will Be Presented on
December 5, 2020
- Study Continues Enrollment to Optimize Dosing and Lymphodepletion
- Preclinical Data Will Also be Presented on ALLO-605, a BCMA TurboCAR T™
Cell Therapyand ALLO-316 Targeting CD70 in Acute Myeloid Leukemia
“We’re looking forward to presenting initial clinical data for our first anti-BCMA AlloCAR T therapy, ALLO-715, which we believe will provide insights into how we might optimize lymphodepletion and cell dose to reach its potential for patients in need of readily available treatments options,” said
In the initial dose escalation phase of the UNIVERSAL trial, patients received lymphodepletion (LD) followed by ALLO-715 at one of three dose levels (DL) in a 3+3 dose escalation design. At the time of the
FCA: Fludarabine 90 mg/m2, Cyclophosphamide 900 mg/m2, and ALLO-647 39 mg divided over three days; and
- CA: Cyclophosphamide 900 mg/m2 and ALLO-647 39 mg divided over three days.
The ASH abstract includes preliminary data on the first 15 patients evaluable for efficacy and treated with escalating doses of ALLO-715 as well as lower dose (39mg) ALLO-647. Patients were in advanced stage of disease with a median of five prior lines of therapy. The trial did not permit bridging therapy.
In 15 evaluable patients, higher dose of ALLO-715 (DL3) achieved greater activity with 60% (3/5) patients responding (95% CI 14.7, 94.7). Of the three patients who received DL3
|LD Regimen and
40 x 106
160 x 106
320 x 106
160 x 106
320 x 106
|ORR, n (%)||0 (0%)||2 (50%)||2 (66%)||0 (0%)||1(50%)||3/5 (60%)
At the time of the data cutoff, 17 of the patients were evaluable for safety. No neurotoxicity or graft-vs-host disease (GvHD) was observed. Cytokine release syndrome (CRS) was reported in four patients (24%) with three Grade 1 and one Grade 2. All CRS was resolved without tocilizumab or corticosteroids. The most common Grade ≥ 3 adverse events were anemia (41.2%), neutropenia (41.2%), lymphopenia (29.4%), and thrombocytopenia (29.4%).
Four (23.5%) instances of Grade ≥ 3 infections were observed. Three of these were Grade 3 and resolved with treatment. The fourth was a Grade 5 event of suspected fungal pneumonia that occurred on day eight post-ALLO-715 infusion. The suspected fungal pneumonia was diagnosed on the day after cell infusion in this patient with advanced and rapidly progressing disease who had failed multiple lines of therapy. This event occurred in the CA cohort, and it was assessed by the investigator as related to progressive disease and the CA conditioning.
The oral presentation will include data on approximately 20 patients evaluable for efficacy across ALLO-715 cell dose cohorts and lower dose (39mg) of ALLO-647, as well as patients evaluable for efficacy who were treated with a higher dose of ALLO-715 and higher doses of ALLO-647. The Phase 1 UNIVERSAL study continues to enroll patients at these higher doses in an effort to optimize the therapy.
The ASH abstracts are now available at www.hematology.org. Allogene will also host a conference call on
Allogene Oral Presentation
Session: 653. Myeloma/Amyloidosis: Therapy, Excluding Transplantation; CAR T Therapies for Myeloma: Novel Approaches and Longer-Term Follow Up Data
Title: Universal: An Allogeneic First-in-Human Study of the Anti-BCMA ALLO-715 and the Anti-CD52 ALLO-647 in Relapsed/Refractory Multiple Myeloma
Presenter: Sham Mailankody, M.D.,
Session Date & Time:
Allogene Poster Presentations
Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Poster II
Title: Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T Targeting CD70 As a Potential Therapy for the Treatment of AML
Session Date & Time:
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster III
Title: Preclinical Evaluation of ALLO-605, an Allogeneic BCMA TurboCAR TTM
Session Date & Time:
About Allogene Therapeutics
Cautionary Note on Forward-Looking Statements
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-715; current data and clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; the ability to initiate and progress a clinical trial of ALLO-715 with a gamma secretase inhibitor; the ability to initiate and progress a clinical trial of ALLO-605; the ability to manufacture AlloCAR T™ therapies; and the potential benefits of AlloCAR T therapies. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
AlloCAR T™ is a trademark of
ALLO-715 (BCMA), ALLO-605 (BCMA) and ALLO-316 (CD70) utilize TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at these targets and holds all global development and commercial rights for these investigational candidates.
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Source: Allogene Therapeutics, Inc.