Adaptimmune's Lete-cel Achieves Primary Endpoint in Pivotal Trial
Adaptimmune Therapeutics (NASDAQ: ADAP) announced positive results from its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS). The trial achieved a 42% response rate (27/64 patients), including six complete responses and 21 partial responses. The median duration of response was 18.3 months for synovial sarcoma and 12.2 months for MRCLS. Based on these results, the company plans to initiate a rolling Biologics License Application submission by end of 2025.
Adaptimmune Therapeutics (NASDAQ: ADAP) ha annunciato risultati positivi dal suo studio clinico pilota di Fase 2 IGNYTE-ESO riguardante lete-cel in pazienti con sarcoma sinoviale o liposarcoma mixoide/rotondo (MRCLS). Lo studio ha raggiunto un tasso di risposta del 42% (27/64 pazienti), inclusi sei risposte complete e 21 risposte parziali. La durata mediana della risposta è stata di 18,3 mesi per il sarcoma sinoviale e di 12,2 mesi per il MRCLS. Sulla base di questi risultati, l'azienda prevede di avviare una presentazione graduale della richiesta di licenza biologica entro la fine del 2025.
Adaptimmune Therapeutics (NASDAQ: ADAP) anunció resultados positivos de su ensayo clínico pivotal de Fase 2 IGNYTE-ESO sobre lete-cel en pacientes con sarcoma sinovial o liposarcoma mixoide/celular redonda (MRCLS). El ensayo logró un tasa de respuesta del 42% (27/64 pacientes), incluyendo seis respuestas completas y 21 respuestas parciales. La duración media de la respuesta fue de 18,3 meses para el sarcoma sinovial y 12,2 meses para el MRCLS. Basándose en estos resultados, la empresa planea iniciar una presentación gradual de la solicitud de licencia biológica para finales de 2025.
Adaptimmune Therapeutics (NASDAQ: ADAP)가 lete-cel의 주요 2상 IGNYTE-ESO 임상 시험에서 긍정적인 결과를 발표했습니다. 이 연구는 활막 육종 또는 점액성/구형 세포 지방육종 (MRCLS) 환자에서 42%의 반응률 (64명 중 27명)을 기록했으며, 이에는 6명의 완전 반응과 21명의 부분 반응이 포함됩니다. 활막 육종의 반응 지속 기간의 중앙값은 18.3개월, MRCLS는 12.2개월입니다. 이러한 결과를 바탕으로 회사는 2025년 말까지 생물학적 제품 허가 신청을 시작할 계획입니다.
Adaptimmune Therapeutics (NASDAQ: ADAP) a annoncé des résultats positifs de son essai clinique pivoter de Phase 2 IGNYTE-ESO concernant lete-cel chez des patients atteints de sarcome synovial ou de liposarcome myxoïde/cellulaire rond (MRCLS). L'essai a atteint un taux de réponse de 42% (27/64 patients), incluant six réponses complètes et 21 réponses partielles. La durée médiane de la réponse était de 18,3 mois pour le sarcome synovial et de 12,2 mois pour le MRCLS. Sur la base de ces résultats, l'entreprise prévoit de soumettre une demande de licence biologique progressive d'ici fin 2025.
Adaptimmune Therapeutics (NASDAQ: ADAP) hat positive Ergebnisse aus seiner entscheidenden Phase-2-Studie IGNYTE-ESO zu lete-cel bei Patienten mit Synovialsarkom oder myxoiden/runden Zell-Liposarkom (MRCLS) bekannt gegeben. Die Studie erzielte eine Antwortquote von 42% (27/64 Patienten), darunter sechs komplette und 21 partielle Antworten. Die mediane Dauer der Antwort betrug 18,3 Monate für Synovialsarkom und 12,2 Monate für MRCLS. Basierend auf diesen Ergebnissen plant das Unternehmen, bis Ende 2025 einen schrittweisen Antrag auf biologisches Lizenzverfahren einzureichen.
- 42% overall response rate in Phase 2 IGNYTE-ESO trial
- Six complete responses and 21 partial responses achieved
- Durable response with median duration of 18.3 months for synovial sarcoma
- Plans to submit BLA by end of 2025
- Treatment doubles addressable patient population for company's cell therapies
- Median progression free survival of only 5.3 months
- All patients experienced treatment-emergent adverse events
- Common adverse events include cytopenias, cytokine release syndrome, and rash
Insights
The clinical trial results for lete-cel represent a significant breakthrough in treating synovial sarcoma and MRCLS. The 42% overall response rate, including 6 complete responses and 21 partial responses, is particularly impressive for these rare and aggressive cancers. The durability of response is notable, with median duration of 18.3 months for synovial sarcoma and 12.2 months for MRCLS.
The safety profile appears manageable with expected side effects like cytopenias and CRS. The planned BLA submission by end of 2025 could position Adaptimmune as a pioneer in cell therapy for these solid tumors, potentially creating a new standard of care for patients with treatment options.
These positive trial results significantly strengthen Adaptimmune's market position in cell therapy for solid tumors. The data supports a clear path to commercialization, with BLA submission planned for 2025. The addressable market opportunity is substantial, as the company notes this doubles their eligible patient population.
For investors, this represents a major de-risking event that could accelerate partnership discussions and improve financing options. With a relatively small market cap of
Results include six complete responses (6/64); twenty-one partial responses (21/64)
Data to be presented at Connective Tissue Oncology Society 2024 Annual Meeting
Company plans to initiate a rolling BLA submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by end of 2025
Company to host virtual KOL event Monday, November 18, 2024; 2:30 PM EST featuring
Dr. Sandra D'Angelo, M.D. (Memorial Sloan Kettering Cancer Center) - register here
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - November 13, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced data from the primary analysis of its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy. The primary analysis data are being presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting which takes place from November 13-16, 2024 in San Diego.
Based on these positive data, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel builds on the potential of Adaptimmune's sarcoma franchise to change the way solid tumors are treated using cell therapies, more than doubling the addressable patient population eligible for Adaptimmune cell therapies to also include NY-ESO-1 positive synovial sarcoma and MRCLS solid tumors.
Sandra D'Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center: "Individuals with both synovial sarcoma and MRCLS are commonly diagnosed under 40, facing a devastating disease with limited treatments in the prime of their lives. I've been seeing these patients throughout my career and have frequently faced the frustrating reality of having incredibly limited treatment options to offer them. I'm encouraged by these data as they could lead to a potential therapeutic option and an improved prognosis for these patients."
Elliot Norry, MD, Adaptimmune's Chief Medical Officer: "We are thrilled to see that
The primary analysis includes data from 64 people with synovial sarcoma or MRCLS who received lete-cel manufactured with the proposed commercial manufacturing process in the IGNYTE-ESO trial. In the analysis, 27/64 (
The median duration of response (DoR) was 12.2 months (
Safety findings were consistent with the known profile of lete-cel from previous data. All patients experienced treatment-emergent adverse events: cytopenias, cytokine release syndrome (CRS) and rash were the most common adverse events. Overall, toxicities were manageable, and consistent with an acceptable benefit to risk profile.
CTOS presentation details:
- Title: Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (Paper 84)
- Session 12: Immunology: Podium presentation
- Presenter: Sandra D'Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center
- Date/Time: Saturday, November 16, 10:30 AM - 12:00 PM PT / 1:30 - 3:00 PM ET
Adaptimmune virtual KOL event November 18th
Adaptimmune will host a virtual event to discuss and review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Sandra D'Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, an investigative clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, and author and presenter of the IGNYTE-ESO data update at CTOS. A live question and answer session will follow the formal presentation. The virtual event will take place on Monday, November 18, 2024 from 2:30 PM ET to 3:30 PM ET. To register, click here.
About the IGNYTE-ESO trial
IGNYTE-ESO is a pivotal, Phase 2, open-label trial for people with previously treated, advanced synovial sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability of lete-cel. Lete-cel's engineered TCR T-cells target NY-ESO-1+ tumors. NY-ESO-1 is a solid tumor antigen highly expressed in synovial sarcoma and MRCLS.
About lete-cel
Lete-cel is an investigational, engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1. Lete-cel is being investigated for the treatment of synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) in the pivotal IGNYTE-ESO (NCT03967223) trial in patients who received prior anthracycline treatment.
About synovial sarcoma
There are approximately 50 types of soft tissue sarcomas which are categorized by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately
About Myxoid/round cell liposarcoma (MRCLS)
MRCLS is one of several types of liposarcoma, a rare cancer that grows in the cells that store fat in the body. MRCLS usually grows in the arms and legs. Each year in the United States, about 2,000 people are diagnosed with liposarcoma. MRCLS is one of the most common types of liposarcoma and makes up about
About Adaptimmune
Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience. For more information, visit https://www.adaptimmune.com/ or follow us on LinkedIn.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Dr. D'Angelo provides consulting and advisory services to Adaptimmune.
Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
T : +1 215 825 9310
M : +1 215 460 8920
Juli.Miller@adaptimmune.com
Media Relations
Dana Lynch, Senior Director of Corporate Communications
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1 "What is a Soft Tissue Sarcoma?" American Cancer Society. https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/soft-tissue-sarcoma.html. Accessed October 24, 2024.
2 "Soft Tissue Sarcoma." Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/21732-soft-tissue-sarcoma. Accessed October 24, 2024.
3 Synovial Sarcoma." National Cancer Institute. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma. Accessed October 24, 2024.
4Aytekin MN, Öztürk R, Amer K, et al. Epidemiology, incidence, and survival of synovial sarcoma subtypes: SEER database analysis. J Orthop Surg (Hong Kong). 2020;28(2):1-12.
5 "Myxoid/round cell liposarcoma" National Cancer Instiute. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/myxoid-round-cell-liposarcoma. Accessed October 24, 2024
6 https://www.orpha.net accessed Oct. 24, 2024
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FAQ
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