On May 22, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the publication of two abstracts on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website in advance of the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 30-June 3 in Chicago, Illinois (Press release, Allogene, MAY 22, 2025, View Source [SID1234653293]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. ALLO-316 is currently being studied in patients with advanced or metastatic renal cell carcinoma (RCC). Leveraging the proprietary Dagger technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The upcoming presentation will share updated data from the Phase 1 TRAVERSE study with a focus on the Phase 1b expansion cohort in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million CAR T cells.
In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy.
Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:
ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CT
Presentation Time: 12:21 PM-12:33 PM CT
ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.
Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM-12:00PM CT
About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.
About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.
About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.