Lyell Presents Positive Initial Clinical Data from the Phase 1-2 Clinical Trial of IMPT-314 for the Treatment of B-cell Lymphoma at the 2024 ASH Annual Meeting
Lyell Immunopharma (NASDAQ: LYEL) has announced positive initial clinical data from its Phase 1-2 trial of IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy for B-cell lymphoma. The trial demonstrated a 94% objective response rate and 71% complete response rate in CAR T-naïve patients with large B-cell lymphoma.
The study involved 23 patients, with 17 being efficacy evaluable. Safety data showed no Grade 3+ cytokine release syndrome, and only 13% experienced Grade 3 ICANS, which resolved with standard treatment. The drug demonstrated robust expansion with peak cell expansion occurring between Days 7-28 post-infusion. Based on these results, Lyell plans to initiate a pivotal trial in 2025 for CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting.
Lyell Immunopharma (NASDAQ: LYEL) ha annunciato dati clinici iniziali positivi dal suo studio di Fase 1-2 relativo a IMPT-314, una terapia CAR T-cell a doppio targeting CD19/CD20 per il linfoma a cellule B. Lo studio ha dimostrato una percentuale di risposta obiettiva del 94% e una percentuale di risposta completa del 71% in pazienti naïve per CAR T con linfoma a grandi cellule B.
Lo studio ha coinvolto 23 pazienti, di cui 17 valutabili per l'efficacia. I dati di sicurezza non hanno mostrato sindrome da rilascio di citochine di Grado 3+, e solo il 13% ha sperimentato ICANS di Grado 3, che si è risolta con il trattamento standard. Il farmaco ha dimostrato un'espansione robusta, con il picco dell'espansione cellulare che si è verificato tra i Giorni 7-28 post-infusione. Sulla base di questi risultati, Lyell prevede di avviare uno studio pivotale nel 2025 per pazienti naïve per CAR T con linfoma a grandi cellule B nel setting di 3ª linea+.
Lyell Immunopharma (NASDAQ: LYEL) ha anunciado datos clínicos iniciales positivos de su ensayo de Fase 1-2 sobre IMPT-314, una terapia CAR T-cell que apunta simultáneamente a CD19 y CD20 para el linfoma de células B. El ensayo demostró una tasa de respuesta objetiva del 94% y una tasa de respuesta completa del 71% en pacientes naïve para CAR T con linfoma de células B grandes.
El estudio incluyó a 23 pacientes, de los cuales 17 fueron evaluables para eficacia. Los datos de seguridad no mostraron síndrome de liberación de citoquinas de Grado 3+, y solo el 13% experimentó ICANS de Grado 3, que se resolvió con tratamiento estándar. El fármaco demostró una expansión robusta, con el pico de expansión celular ocurriendo entre los Días 7-28 después de la infusión. Basándose en estos resultados, Lyell planea iniciar un ensayo pivotal en 2025 para pacientes naïve para CAR T con linfoma de células B grandes en la 3ª línea o más.
Lyell Immunopharma (NASDAQ: LYEL)는 IMPT-314의 1-2상 시험에서 긍정적인 초기 임상 결과를 발표했습니다. 이는 B세포 림프종을 위한 CD19/CD20 이중 타겟 CAR T세포 치료제입니다. 시험 결과 CAR T 미경험 환자에서 94%의 객관적 반응률과 71%의 완전 반응률을 보였습니다.
이 연구에는 23명의 환자가 포함되었으며, 그 중 17명이 효능 평가가 가능했습니다. 안전성 데이터는 3등급 이상의 사이토카인 방출 증후군이 없음을 보여주었으며, 단지 13%만이 3등급 ICANS를 겪었고 이는 표준 치료로 해결되었습니다. 이 약물은 robust한 확장을 보여주었으며 세포 확장이 정맥 주입 후 7-28일 사이에 가장 정점에 달했습니다. 이러한 결과에 따라 Lyell은 2025년에 3차 치료 이상의 대규모 B세포 림프종 CAR T 미경험 환자에 대한 주요 시험을 시작할 계획입니다.
Lyell Immunopharma (NASDAQ: LYEL) a annoncé des données cliniques initiales positives de son essai de Phase 1-2 sur IMPT-314, une thérapie CAR T-cell ciblant simultanément CD19 et CD20 pour le lymphome à cellules B. L'essai a montré un taux de réponse objectif de 94% et un taux de réponse complète de 71% chez des patients naïfs de CAR T souffrant de lymphome à grandes cellules B.
L'étude a impliqué 23 patients, dont 17 ont pu être évalués pour l'efficacité. Les données de sécurité n'ont montré aucun syndrome de libération de cytokines de Grade 3+ et seulement 13% ont présenté des ICANS de Grade 3, qui se sont résolus avec un traitement standard. Le médicament a montré une expansion robuste, avec un pic d'expansion cellulaire survenant entre les Jours 7 et 28 après l'infusion. Sur la base de ces résultats, Lyell prévoit de lancer un essai pivot en 2025 pour les patients naïfs de CAR T souffrant de lymphome à grandes cellules B dans le cadre de la 3e ligne ou plus.
Lyell Immunopharma (NASDAQ: LYEL) hat positive erste klinische Daten aus seiner Phase 1-2-Studie zu IMPT-314, einer dual-targeting CD19/CD20 CAR-T-Zelltherapie für B-Zell-Lymphom, veröffentlicht. Die Studie zeigte eine objektive Ansprechrate von 94% und eine vollständige Ansprechrate von 71% bei CAR-T-naiven Patienten mit großzelligem B-Zell-Lymphom.
Die Studie umfasste 23 Patienten, von denen 17 auf Wirksamkeit evaluiert werden konnten. Die Sicherheitsdaten zeigten kein Grad-3+ Zytokinfreisetzungssyndrom und nur 13% erlebten Grad-3 ICANS, welches mit Standardbehandlung behoben wurde. Das Medikament zeigte eine robuste Expansion, wobei der Höhepunkt der Zellexpansion zwischen Tag 7-28 nach der Infusion auftrat. Basierend auf diesen Ergebnissen plant Lyell, 2025 eine entscheidende Studie für CAR-T-naive Patienten mit großzelligem B-Zell-Lymphom in der 3. Linie oder höher zu starten.
- High efficacy with 94% objective response rate and 71% complete response rate
- Favorable safety profile with no high-grade cytokine release syndrome
- Strong drug performance with robust cell expansion
- Advancement to pivotal trial planned for 2025
- 91% median desired naïve and central memory cell phenotype achieved
- 13% of patients experienced Grade 3 ICANS adverse events
Insights
- Objective response rate (ORR) of
94% and a complete response (CR) rate of71% demonstrated after IMPT-314 treatment in CAR T-naïve patients with large B-cell lymphoma who had received at least 2 prior lines of therapy - Manageable safety profile with no high-grade cytokine release syndrome (CRS) and low rates of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS); adverse events were resolved with standard treatment protocols
- Initial clinical data are consistent with clinical experience from UCLA trial of CART19/20, a product candidate with the same CAR construct as IMPT-314 that has demonstrated durable responses in a Phase 1 trial of patients with non-Hodgkin lymphoma
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, today announced initial positive clinical data from the multi-center Phase 1-2 study of IMPT-314 in patients with large B-cell lymphoma that is being presented at the 66th American Society of Hematology (ASH) Annual Meeting. IMPT-314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin lymphoma.
As of October 22, 2024 (the data cutoff for the presentation), 23 patients with relapsed or refractory (R/R), CAR T-naive large B-cell lymphoma received IMPT-314. The efficacy evaluable population consisted of 17 patients. The ORR was
The data are being presented today at the 2024 ASH Annual Meeting by Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, and the poster is available in the Investors’ section of the Company’s website.
“The high rate of complete responses with a favorable safety profile support the strong potential of IMPT-314, Lyell’s next-generation dual-targeting CAR T-cell therapy enriched for naïve and central memory T cells. This product candidate was designed to maximize durable responses by overcoming heterogeneous CD19 antigen density and antigen escape, enhance CAR T cell persistence, and reduce exhaustion,” said Lynn Seely, M.D., Lyell’s President and Chief Executive Officer. “Based on these strong data, we remain on track to initiate a pivotal trial in 2025 of IMPT-314 in CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting and are continuing to evaluate IMPT-314 in the 2nd-line setting in the ongoing Phase 1-2 trial.”
“The data presented today from IMPT-314 suggest the potent targeting of both CD19 and CD20 coupled with CD62L+ cell enrichment has the potential to provide differentiated benefit in objective and complete response rates over first-generation CD19 CAR therapies in patients with aggressive large B-cell lymphoma,” stated Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA. “IMPT-314 incorporates the same CAR construct as CART19/20 which was evaluated in a Phase 1 trial at UCLA, and I am pleased that the IMPT-314 data are consistent with our experience at UCLA.”
About IMPT-314
IMPT-314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the response as compared to the approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma.
IMPT-314 is designed with an ‘OR’ logic gate to target B cells that express either CD19, CD20 or both. IMPT-314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity.
IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma.
About Lyell
Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer. Lyell’s product candidates are designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. Lyell is based in South San Francisco, California with facilities in West Hills, California and Seattle and Bothell, Washington. To learn more, please visit www.lyell.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the anticipated benefits IMPT-314, including its potential to maximize durable responses by overcoming heterogeneous CD19 antigen density and antigen escape, enhancing CAR T cell persistence and reducing exhaustion; the continued clinical progress of the IMPT-314 trials and expectations around the timing of updated clinical data and the timing and design of a pivotal trial of IMPT-314; the potential of IMPT-314 to provide differentiated benefit in objective and complete response rates over first-generation CD19 CAR therapies; the ability of Lyell’s technology to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response; Lyell’s anticipated progress, business plans, business strategy and clinical trials; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the inability to recognize the anticipated benefits of Lyell’s recent acquisition of ImmPACT Bio and successful integration of ImmPACT Bio’s business with Lyell’s, including manufacturing IMPT-314 in Lyell’s LyFE manufacturing facility; the effects of macroeconomic conditions, including any geopolitical instability and actual or perceived changes in interest rates and economic inflation; Lyell’s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell’s limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; the nonclinical profiles of Lyell’s product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; the significant uncertainty associated with Lyell’s product candidates ever receiving any regulatory approvals; Lyell’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell’s strategic plans for its business and product candidates; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 7, 2024. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
FAQ
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