Allogene Therapeutics, with Collaborator Servier, Reports Positive Results from its Phase 1 ALPHA Study of ALLO-501 in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology Annual Meeting
- ALLO-501 with ALLO-647 Lymphodepletion was Well Tolerated with No Dose-Limiting Toxicities, Graft-vs-Host Disease or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
- In the Ongoing Study, 22 Patients were Evaluable for Safety and 19 Patients Were Evaluable for Efficacy with at Least One Tumor Assessment as of Data Cutoff
- Seven Complete Responses (CR) and Five Partial Responses (PR) were Observed for an Overall Response Rate (ORR) of 63% and CR Rate of 37%
- Higher Response Rates Observed in CAR T Naïve Patients (N=16) with an ORR of 75% and CR Rate of 44%
- Nine of 12 (75%) Patients Remain in Response as of the Data Cutoff
- Higher Dose ALLO-647 Associated with Higher CR Rates
- Phase 1 Trial Initiated for ALLO-501A, a Next Generation Anti-CD19 AlloCAR T™ Candidate Intended for Phase 2 Development
- Company to Host a Live Webinar on
Friday, May 29at 8:30 AM Eastern Time
“We are very pleased with these initial Phase 1 results, which indicated that ALLO-501 and ALLO-647 were well tolerated and produced complete responses in patients with advanced NHL,” said
“Allogeneic CAR T therapies provide an off-the-shelf option that may make cellular therapies available to more patients,” said Sattva S. Neelapu, M.D., Professor,
As of the
For the efficacy analysis, 19 out of 22 patients reached at least one month assessment as of the
|39mg ALLO-647||90mg ALLO-647||All Patients
|40 x 106
|120 x 106
|360 x 106
|120 x 106
|360 x 106
|ORR, n (%)||3 (75%)||3 (75%)||1 (33%)||7 (64%)||4 (67%)||1(50%)||5 (63%)||12/19 (63%)
|CR, n (%)||1 (25%)||1 (25%)||1 (33%)||3 (27%)||4 (67%)||0 (0%)||4 (50%)||7/19 (37%)
One of the ongoing responders is a patient with an initial partial response (PR) who progressed by month two. This patient achieved a CR after re-treatment with the same dose of ALLO-501 and higher dose (90mg) ALLO-647. This patient is reflected as a PR in the table above and not as a CR.
Included in the overall efficacy analysis are three patients who were refractory to prior autologous CAR T therapy (the best response of progressive disease or disease progression within three months). These patients were also refractory to AlloCAR T therapy. In CAR T naïve patients, the ORR was 75% and the CR rate was 44%.
|All Cell Doses +
|120 x 106 and 360 x 106 CAR+ cells +
|All CAR T Naïve Patients
|ORR, n (%)||7 (70%)||5 (83%)||12/16 (75%)
|CR, n (%)||3 (30%)||4 (67%)||7/16 (44%)
No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed.
|Adverse Events of Interest||Grade 1
|Cytokine Release Syndrome||2 (9%)||4 (18%)||1 (5%)||-||-|
|Infection||5 (23%)||4 (18%)||2 (9%)||-||-|
|Infusion Reaction||1 (5%)||9 (41%)||1 (5%)||-||-|
|Neutropenia||-||1 (5%)||7 (32%)||7 (32%)||-|
Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate in severity, manageable with standard recommendations, and all events resolved within a maximum of seven days. Patients treated with 90mg ALLO-647 did not experience an increase in infection as compared to those treated with 39mg ALLO-647.
Four patients (18%) experienced serious adverse events (SAE). One patient had Grade 2 pyrexia and Grade 2 cytomegalovirus (CMV) reactivation which resolved in two days and six days, respectively. One patient had Grade 3 rotavirus infection and Grade 3 hypokalemia which resolved in 15 days and two days, respectively. One patient had Grade 3 febrile neutropenia and Grade 3 hypotension which each resolved in two days. One patient had a Grade 3 upper GI hemorrhage which resolved in one day and Grade 3 CMV reactivation which resolved in 25 days.
Adverse events were observed across all dose levels of ALLO-501 and ALLO-647. SAEs were observed at ALLO-501 cell dose level 40 x 106 and 120 x 106 and at both dose levels of ALLO-647.
“We are pleased to see the progress made by Allogene in the ALPHA trial and the positive initial data for ALLO-501,” said
Allogene is the sponsor of the Phase 1 ALPHA trial which is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 and ALLO-647 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma or follicular lymphoma.
ALLO-501A is a next generation anti-CD19 AlloCAR T devoid of the rituximab recognition domains found in ALLO-501. This could allow for use in a broader patient population, including those NHL patients with recent rituximab exposure. ALLO-501A is intended for Phase 2 development and enrollment has been initiated in the Phase 1 portion of the ALPHA2 trial of ALLO-501A.
Please register for the webinar on the Company's website at www.allogene.com under the Investors tab in the News and Events section (https://ir.allogene.com/events) or by clicking the following link directly.
The webinar will be available as a live event only and the materials presented will be available on the Allogene website prior to the start of the event.
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
Jean-Clément Vergeau: firstname.lastname@example.org – Tel. +33 (0)1 55 46 16 / +33 6 79 56 75 96
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: clinical outcomes, which may materially change as patient enrollment continues and more patient data become available, the ability to progress the clinical trials of ALLO-501 and ALLO-501A, the potential for ALLO-501A to have similar clinical outcomes as ALLO-501, 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
AlloCAR T™ is a trademark of
Allogene Media/Investor Contact:
Chief Communications Officer
Source: Allogene Therapeutics, Inc.