Allogene Therapeutics Presents Positive Phase 1 Data on ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma at the 2021 Annual Meeting of the American Society of Clinical Oncology
- ASCO Posters Detail Results from ALLO-501 ALPHA and ALLO-501A ALPHA2 Trials in Non-Hodgkin Lymphoma and Safety and PK/PD Data of ALLO-647 with Flu/Cy Across the ALPHA, ALPHA2 and UNIVERSAL Studies
- Results from Most Recent Data Discussed at Allogene’s CD19 Forum Demonstrated Six Month Complete Response (CR) Rate of 36% in CAR T Naïve LBCL Patients Treated with ALLO-501
- Longest Ongoing CR at 15 Months in Both Large B Cell Lymphoma (LBCL) and Follicular Lymphoma (FL)
- Overall Response Rate (ORR) of 75% and CR Rate of 50% Across Histologies in CAR T Naïve Patients on Par with Autologous CAR T Therapies
- 98% of Enrolled Patients Received ALLO-501 With a Median Time of 5 Days from Enrollment to Start of Therapy
- ALLO-501A Demonstrated Comparable Efficacy and Safety to ALLO-501
- Consolidation Dosing was Well Tolerated and Shows Early Promise with Four Patients Converting from Partial Response (PR) to CR Following Second Dose of ALLO-501 or ALLO-501A
- No Dose Limiting Toxicities or Graft-vs-Host Disease; Limited Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Cytokine Release Syndrome (CRS)
- Initiation of a Potentially Pivotal Trial of ALLO-501A Expected by End of 2021; Next CD19 Program Clinical Update Planned for Late 2021
“Allogene is demonstrating that allogeneic CAR T has the potential to compete with autologous therapies, as well as expand the use of cell therapy by leveraging the unique benefits of an off-the-shelf product to treat every eligible patient,” said
The ASCO presentations include data from Phase 1 ALPHA (ALLO-501) and ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin lymphoma (NHL), developed in collaboration with
Due to the virtual nature of the meeting, the ASCO presentations were finalized in advance of Allogene’s
The Company intends to initiate a Phase 2 trial with ALLO-501A, pending regulatory feedback, by the end of 2021. The next clinical update on the CD19 program is planned for Q4 2021.
Phase 1 ALLO-501 ALPHA Trial
Data presented from the ALPHA trial supports the ability of a single administration of ALLO-501 to generate deep and durable responses at a rate that is similar to approved autologous CAR T therapies. As of the
Responses were observed across all cell doses and tumor histologies (large B-cell lymphoma (LBCL) and follicular lymphoma (FL)). In CAR T naïve patients, response rates were:
|LBCL (N=11)||FL (N=21)||All Patients (N=32)|
The percent of these patients remaining in complete response at six months following a single infusion was 29%, with 36% in LBCL and 24% in FL. An additional four FL patients in response have yet to reach the six month timepoint. As of
Redosing led to clinical responses, with an overall Treatment Failure Free Survival (TFFS) for autologous naïve patients of 64% and 61% at six months for FL and LBCL, respectively.
ALLO-647 was used in lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) at doses ranging from 39mg to 90mg. No dose limiting toxicities or graft-vs-host disease (GvHD) were observed and one (2%) case of Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was reported. Cytokine release syndrome (CRS) occurred in 27% of patients, was limited to Grade 1 or 2, and was manageable with standard protocols. Infection rates were similar to those observed in autologous CAR T trials. During this study, there were five treatment-emergent deaths in the absence of disease progression, one each from pneumonia, arrythmia, and stroke, and two instances of COVID-19 acquired in the community setting. Three of these patients were in ongoing CR at the time of death.
|ALLO-647 39 mg
|ALLO-647 60 mg
|ALLO-647 90 mg
|All Patients (N=41)|
|All Gr||Gr 3+||All Gr||Gr 3+||All Gr||Gr 3+||All Gr||Gr 3+|
|IRR||5 (46%)||-||3 (50%)||-||18 (75%)||1 (4)||26 (63%)||1 (2%)|
|CRS||2 (18%)||-||1 (17%)||-||8 (33%)||-||11 (27%)||-|
|ICANS||-||-||-||-||1 (4%)||1 (4%)||1 (2%)||1 (2%)|
|Infection||7 (64%)||1 (9%)||1 (17%)||1 (17%)||17 (71%)||8 (33%)||25 (61%)||10 (24%)|
Phase 1 ALLO-501A ALPHA2 Trial
ALLO-501A is a next generation anti-CD19 AlloCAR T candidate intended for a pivotal trial and is engineered without the rituximab recognition domains included in ALLO-501. This trial is only enrolling patients with relapsed/refractory LBCL.
Following promising efficacy data from patients (N=4) treated at dose level 2 (120 x 106 CAR+ cells; DL2), patient enrollment in ALPHA2 focused on exploration of a consolidated dosing strategy that enabled patients who did not progress following an initial dose of ALLO-501A to receive a second, scheduled dose of cells. In consolidation dosing, 60mg ALLO-647 was provided with Flu/Cy for lymphodepletion before the first cell administration at DL2, and 30mg ALLO-647 with no Flu/Cy was provided for lymphodepletion before the second cell infusion at DL2 to patients with selective hematologic criteria.
As of the
|DL2 (N=4)||Consolidation (N=5)||All Patients (N=9)|
No dose limiting toxicities, GvHD or ICANS were observed in ALPHA2.
40 x 106 (40M)
120 x 106 (120M)
CAR+ cells (N=5)
(120M + 120M)
|All Patients (N=13)*|
|All Gr||Gr 3+||All Gr||Gr 3+||All Gr||Gr 3+||All Gr||Gr 3+|
|IRR||1 (100%)||-||2 (40%)||-||2 (33%)||-||5 (39%)||-|
|CRS||1 (100%)||1 (100%)||1 (20%)||-||-||-||2 (15%)||1 (8%)|
|Infection||1 (100%)||-||4 (80%)||1 (20%)||2 (33%)||-||7 (54%)||1 (8%)|
* One patient was treated with ALLO-647 but not ALLO-501A due to disease progression.
About ALLO-501 (Allogene Sponsored)
ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly developed under a collaboration agreement between
About ALLO-501A (Allogene Sponsored)
ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for Phase 2 development, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. Like ALLO-501, ALLO-501A is being jointly developed under a collaboration agreement between
Cautionary Note on Forward-Looking Statements for Allogene
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 timing and ability to progress the ALPHA and ALPHA2 trials, including progressing to the Phase 2 portion of the ALPHA2 trial; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; and the potential benefits of AlloCAR T™ therapy and the Company’s lymphodepletion strategy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-Q for the quarter ended March 31, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Statements regarding autologous CAR T data are based on review of Kymriah United States product insert (USPI), Schuster S et
AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.
Allogene’s AlloCAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 allogeneic CAR T (AlloCAR T™) therapies being jointly developed under a collaboration agreement between Servier1 and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries.
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