Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Allogene Therapeutics (NASDAQ: ALLO) will present updated data from two significant clinical trials at the 2025 ASCO Annual Meeting. The first presentation features results from the completed Phase 1 TRAVERSE trial of ALLO-316, their allogeneic CAR T product targeting CD70 in renal cell carcinoma (RCC). Previous data showed promising safety and anti-tumor activity in heavily pretreated patients with advanced CD70+ RCC.
The second presentation highlights their ongoing pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL). This groundbreaking study is the first to evaluate an allogeneic CAR T product as first-line consolidation treatment. The randomized trial will enroll approximately 240 patients and aims to improve event-free survival compared to standard care.
Allogene Therapeutics (NASDAQ: ALLO) presenterà dati aggiornati da due importanti studi clinici al Congresso Annuale ASCO 2025. La prima presentazione riguarda i risultati dello studio di Fase 1 TRAVERSE completato su ALLO-316, il loro prodotto CAR T allogenico che mira a CD70 nel carcinoma renale (RCC). Dati precedenti avevano mostrato una promettente sicurezza e attività antitumorale in pazienti fortemente pretrattati con RCC avanzato CD70+.
La seconda presentazione mette in evidenza il loro studio pivotale in corso di Fase 2, il trial ALPHA3, su cemacabtagene ansegedleucel (cema-cel) nel linfoma a grandi cellule B (LBCL). Questo studio innovativo è il primo a valutare un prodotto CAR T allogenico come trattamento di consolidamento di prima linea. Lo studio randomizzato arruolerà circa 240 pazienti e mira a migliorare la sopravvivenza libera da eventi rispetto alla terapia standard.
Allogene Therapeutics (NASDAQ: ALLO) presentará datos actualizados de dos ensayos clínicos importantes en la Reunión Anual ASCO 2025. La primera presentación incluye resultados del ensayo de Fase 1 TRAVERSE finalizado con ALLO-316, su producto CAR T alogénico dirigido a CD70 en carcinoma de células renales (RCC). Datos previos mostraron seguridad prometedora y actividad antitumoral en pacientes con RCC avanzado CD70+ altamente pretratados.
La segunda presentación destaca su ensayo pivotal de Fase 2 en curso, el ensayo ALPHA3, con cemacabtagene ansegedleucel (cema-cel) en linfoma de células B grandes (LBCL). Este estudio innovador es el primero en evaluar un producto CAR T alogénico como tratamiento de consolidación de primera línea. El ensayo aleatorizado inscribirá aproximadamente a 240 pacientes y busca mejorar la supervivencia libre de eventos en comparación con el tratamiento estándar.
Allogene Therapeutics (NASDAQ: ALLO)는 2025년 ASCO 연례회의에서 두 건의 주요 임상시험 업데이트 데이터를 발표할 예정입니다. 첫 번째 발표는 완료된 1상 TRAVERSE 시험의 결과로, 신세포암(RCC)을 표적으로 하는 동종 CAR T 제품 ALLO-316에 관한 것입니다. 이전 데이터는 중증으로 치료받은 진행성 CD70+ RCC 환자에서 유망한 안전성과 항종양 활성을 보여주었습니다.
두 번째 발표는 진행 중인 2상 핵심 ALPHA3 시험을 강조하며, 대형 B세포 림프종(LBCL)에 대한 cemacabtagene ansegedleucel(cema-cel)입니다. 이 획기적인 연구는 동종 CAR T 제품을 1차 통합 치료로 평가하는 최초의 연구입니다. 무작위 배정된 이 시험은 약 240명의 환자를 모집하며, 표준 치료 대비 무사건 생존율 향상을 목표로 합니다.
Allogene Therapeutics (NASDAQ : ALLO) présentera des données actualisées issues de deux essais cliniques majeurs lors de la réunion annuelle ASCO 2025. La première présentation porte sur les résultats de l’essai de phase 1 TRAVERSE achevé concernant ALLO-316, leur produit CAR T allogénique ciblant CD70 dans le carcinome rénal (RCC). Les données précédentes avaient montré une sécurité prometteuse et une activité antitumorale chez des patients fortement prétraités atteints de RCC avancé CD70+.
La seconde présentation met en lumière leur essai pivot de phase 2 en cours, l’essai ALPHA3, portant sur cemacabtagène ansegedleucel (cema-cel) dans le lymphome à grandes cellules B (LBCL). Cette étude révolutionnaire est la première à évaluer un produit CAR T allogénique en traitement de consolidation de première ligne. L’essai randomisé recrutera environ 240 patients et vise à améliorer la survie sans événement par rapport au traitement standard.
Allogene Therapeutics (NASDAQ: ALLO) wird auf dem ASCO Jahreskongress 2025 aktualisierte Daten aus zwei bedeutenden klinischen Studien vorstellen. Die erste Präsentation zeigt Ergebnisse der abgeschlossenen Phase-1-TRAVERSE-Studie zu ALLO-316, ihrem allogenen CAR-T-Produkt, das CD70 beim Nierenzellkarzinom (RCC) anvisiert. Frühere Daten zeigten vielversprechende Sicherheit und antitumorale Aktivität bei stark vorbehandelten Patienten mit fortgeschrittenem CD70+ RCC.
Die zweite Präsentation hebt ihre laufende entscheidende Phase-2-Studie, die ALPHA3-Studie, zu cemacabtagene ansegedleucel (cema-cel) beim großzelligen B-Zell-Lymphom (LBCL) hervor. Diese bahnbrechende Studie ist die erste, die ein allogenes CAR-T-Produkt als Erstlinien-Konsolidierungsbehandlung bewertet. Die randomisierte Studie wird etwa 240 Patienten einschließen und zielt darauf ab, das ereignisfreie Überleben im Vergleich zur Standardbehandlung zu verbessern.
- First allogeneic CAR T product showing potential in solid tumors
- Positive safety profile and anti-tumor activity in RCC trial
- Large-scale Phase 2 trial with 240 patients for LBCL treatment
- Innovation in first-line treatment approach for lymphoma
- ALLO-316 still in early Phase 1 stage for RCC treatment
- Efficacy data from ALPHA3 trial not yet available
Insights
Allogene advances two key CAR T programs with ALLO-316 solid tumor data and pivotal cema-cel trial in first-line lymphoma treatment.
Allogene's upcoming ASCO presentations highlight significant progress in their allogeneic CAR T pipeline. The oral presentation format for ALLO-316 data deserves attention, as ASCO typically reserves this format for more compelling findings. ALLO-316 targets CD70 in renal cell carcinoma and is specifically noted as "the only allogeneic CAR T product to demonstrate potential in solid tumors" - addressing a crucial limitation in current CAR T therapy scope.
The completed enrollment in the Phase 1b expansion cohort evaluating ALLO-316 at 80M CAR T cells following standard lymphodepletion represents an important milestone. Previous data showed a "manageable safety profile and encouraging anti-tumor activity" in heavily pretreated RCC patients who had progressed after both immune checkpoint inhibitors and VEGF-targeted therapies.
Equally notable is the pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel (cema-cel), which pioneers a novel approach: using allogeneic CAR T as consolidation therapy after first-line treatment in large B-cell lymphoma. This trial specifically targets patients with minimal residual disease (MRD) detected through a specialized assay, focusing treatment on those at highest risk of relapse.
The trial design - randomizing approximately 240 patients with event-free survival as the primary endpoint - demonstrates a methodologically rigorous approach to evaluating if early intervention with CAR T therapy can improve cure rates in first-line LBCL treatment. This represents a significant expansion of CAR T applications from the current later-line treatment paradigm.
Allogene demonstrates clinical progress with completed ALLO-316 solid tumor enrollment and advancement of first pivotal allogeneic CAR T trial in first-line lymphoma.
Allogene's dual presentations at ASCO highlight strategic advancement of their allogeneic CAR T platform across two key programs. The completed enrollment in the ALLO-316 Phase 1b expansion cohort is a positive operational milestone, enabling a comprehensive data package for this CD70-targeting therapy in renal cell carcinoma.
What makes ALLO-316 particularly significant is its potential in solid tumors, where CAR T approaches have historically struggled. As the company notes, it's "the only allogeneic CAR T product to demonstrate potential in solid tumors" - positioning it uniquely in the competitive landscape if efficacy continues to be demonstrated.
The pivotal Phase 2 ALPHA3 trial for cema-cel represents Allogene's first program to advance to this later clinical stage. The trial's design - evaluating CAR T therapy as consolidation after first-line chemoimmunotherapy to eradicate minimal residual disease - targets a specific unmet need: improving cure rates in newly diagnosed large B-cell lymphoma patients.
This innovative approach uses sophisticated MRD detection technology (Foresight CLARITY with PhasED-Seq) to identify high-risk patients, potentially creating a precision medicine paradigm for CAR T therapy. The randomized trial design with approximately 240 patients provides statistical power to demonstrate meaningful improvement in event-free survival compared to the current standard of care (observation).
Both programs highlight Allogene's progress in advancing "off-the-shelf" allogeneic CAR T therapies, which offer potential advantages in manufacturing time, accessibility, and standardization compared to autologous approaches.
SOUTH SAN FRANCISCO, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- 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, today announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL).
ALLO-316 is an allogeneic, “off-the-shelf” CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine.
The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY™, powered by PhasED-Seq™, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).
Allogene Presentations at the 2025 ASCO 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
Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT
ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) 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 a
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
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.
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. This press release may, in some cases, use terms such as “develop,” “potential,” “encouraging,” “expect,” “can,” “see if,” “positioning,” “become,” “may,” “could,” “designed to,” “aim,” or “will,” including alternative forms thereof, 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: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the potential for the ALPHA3 trial and an investigational minimal residual disease test to identify patients with LBCL who are at high risk for relapse after 1L treatment; the potential for cema-cel to become the standard “7th cycle” of frontline treatment; the potential for cema-cel to eradicate MRD or demonstrate a meaningful improvement in event free survival in patients treated with cema-cel relative to patients who receive current standard of care; that cema-cel can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy; the timing for completion of ALPHA3 enrollment or cema-cel BLA submission; the incidence of LBCL including the extent to which patients will relapse and require subsequent treatment; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; cema-cel’s safety profile; the potential of ALLO-316 as a treatment for patients with advanced or metastatic CD70+ RCC; the potential for ALLO-316 and CAR T-cell therapy to treat hematologic malignancies and solid tumors; our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation under the “Risk Factors” heading in its Quarterly Report on Form 10-K for the year ended December 31, 2024. 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.
AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.
CLARITY™ and PhasED-Seq™ are trademarks of Foresight Diagnostics.
Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD19 products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T™ investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom.
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
(714) 552-0326
Christine.Cassiano@allogene.com
FAQ
What are the key findings from Allogene's ALLO-316 Phase 1 TRAVERSE trial in kidney cancer?
How many patients will be enrolled in Allogene's Phase 2 ALPHA3 trial for LBCL?
What makes ALLO-316 unique in solid tumor treatment?
How does Allogene's ALPHA3 trial identify high-risk LBCL patients?
