Ignite Proteomics to Present Data on MHC-II as a Predictor of Pembrolizumab Response at NCCN Annual Conference
Ignite Proteomics, a subsidiary of IMAC Holdings (Nasdaq: BACK), has announced groundbreaking data showing MHC-II protein expression as a superior predictor of pembrolizumab (Keytruda®) response compared to PD-L1. The findings will be presented at the upcoming National Comprehensive Cancer Network (NCCN) Annual Conference.
The study, conducted using I-SPY 2 clinical trial results, evaluated five different PD-L1 antibodies, including the commonly used companion diagnostic. Only MHC-II expression demonstrated statistically significant correlation with patient outcomes. Patients with higher MHC-II protein levels showed nearly double the response rate compared to unselected patients.
The I-SPY 2 trial, focusing on high-risk stage II and III breast cancer patients undergoing neoadjuvant treatment, is a multicenter, adaptive platform trial. The research suggests that MHC-II testing could significantly improve care by enabling more precise therapy decisions, particularly in cancer types where no biomarker testing is currently used.
Ignite Proteomics, una filiale di IMAC Holdings (Nasdaq: BACK), ha annunciato dati innovativi che mostrano come l'espressione della proteina MHC-II sia un predittore superiore della risposta al pembrolizumab (Keytruda®) rispetto al PD-L1. I risultati saranno presentati alla prossima Conferenza Annuale della National Comprehensive Cancer Network (NCCN).
Lo studio, condotto utilizzando i risultati del trial clinico I-SPY 2, ha valutato cinque diversi anticorpi anti-PD-L1, incluso il diagnostico companion comunemente utilizzato. Solo l'espressione di MHC-II ha dimostrato una correlazione statisticamente significativa con gli esiti dei pazienti. I pazienti con livelli più elevati di proteina MHC-II hanno mostrato quasi il doppio del tasso di risposta rispetto ai pazienti non selezionati.
Il trial I-SPY 2, che si concentra su pazienti con tumore al seno di stadio II e III ad alto rischio sottoposti a trattamento neoadiuvante, è un trial multicentrico e adattivo. La ricerca suggerisce che il test di MHC-II potrebbe migliorare significativamente l'assistenza, consentendo decisioni terapeutiche più precise, in particolare nei tipi di cancro in cui attualmente non sono utilizzati test biomarker.
Ignite Proteomics, una subsidiaria de IMAC Holdings (Nasdaq: BACK), ha anunciado datos innovadores que muestran que la expresión de la proteína MHC-II es un predictor superior de la respuesta al pembrolizumab (Keytruda®) en comparación con PD-L1. Los hallazgos se presentarán en la próxima Conferencia Anual de la National Comprehensive Cancer Network (NCCN).
El estudio, realizado utilizando los resultados del ensayo clínico I-SPY 2, evaluó cinco anticuerpos diferentes contra PD-L1, incluido el diagnóstico companion comúnmente utilizado. Solo la expresión de MHC-II demostró una correlación estadísticamente significativa con los resultados de los pacientes. Los pacientes con niveles más altos de proteína MHC-II mostraron casi el doble de la tasa de respuesta en comparación con los pacientes no seleccionados.
El ensayo I-SPY 2, que se centra en pacientes con cáncer de mama en estadio II y III de alto riesgo que reciben tratamiento neoadyuvante, es un ensayo multicéntrico y adaptativo. La investigación sugiere que la prueba de MHC-II podría mejorar significativamente la atención al permitir decisiones terapéuticas más precisas, particularmente en tipos de cáncer donde actualmente no se utilizan pruebas de biomarcadores.
Ignite Proteomics는 IMAC Holdings(Nasdaq: BACK)의 자회사로서, MHC-II 단백질 발현이 PD-L1에 비해 펨브롤리주맙(Keytruda®)의 반응을 예측하는 데 우수하다는 혁신적인 데이터를 발표했습니다. 이 결과는 다가오는 국립 종합 암 네트워크(NCCN) 연례 회의에서 발표될 예정입니다.
이 연구는 I-SPY 2 임상 시험 결과를 사용하여 수행되었으며, 일반적으로 사용되는 동반 진단을 포함하여 다섯 가지 PD-L1 항체를 평가했습니다. 오직 MHC-II 발현만이 환자 결과와 통계적으로 유의미한 상관관계를 나타냈습니다. MHC-II 단백질 수치가 높은 환자들은 비선택 환자에 비해 거의 두 배의 반응률을 보였습니다.
I-SPY 2 시험은 고위험 II 및 III기 유방암 환자를 대상으로 하는 선행 치료를 중심으로 한 다기관 적응형 플랫폼 시험입니다. 연구 결과는 MHC-II 검사가 현재 바이오마커 검사가 사용되지 않는 암 유형에서 보다 정확한 치료 결정을 가능하게 하여 치료 개선에 크게 기여할 수 있음을 시사합니다.
Ignite Proteomics, une filiale d'IMAC Holdings (Nasdaq: BACK), a annoncé des données révolutionnaires montrant que l'expression de la protéine MHC-II est un prédicteur supérieur de la réponse au pembrolizumab (Keytruda®) par rapport au PD-L1. Les résultats seront présentés lors de la prochaine Conférence Annuelle du National Comprehensive Cancer Network (NCCN).
L'étude, réalisée à partir des résultats de l'
L'essai I-SPY 2, qui se concentre sur les patients atteints de cancer du sein de stade II et III à haut risque recevant un traitement néoadjuvant, est un essai multicentrique et adaptatif. La recherche suggère que le test MHC-II pourrait améliorer considérablement les soins en permettant des décisions thérapeutiques plus précises, en particulier dans les types de cancer où aucun test de biomarqueur n'est actuellement utilisé.
Ignite Proteomics, eine Tochtergesellschaft von IMAC Holdings (Nasdaq: BACK), hat bahnbrechende Daten veröffentlicht, die zeigen, dass die Expression des MHC-II-Proteins ein überlegener Prädiktor für die Reaktion auf Pembrolizumab (Keytruda®) im Vergleich zu PD-L1 ist. Die Ergebnisse werden auf der bevorstehenden Jahrestagung des National Comprehensive Cancer Network (NCCN) präsentiert.
Die Studie, die auf den Ergebnissen der I-SPY 2-Studie basiert, bewertete fünf verschiedene PD-L1-Antikörper, einschließlich des häufig verwendeten Begleitdiagnosetests. Nur die MHC-II-Expression zeigte eine statistisch signifikante Korrelation mit den Patientenergebnissen. Patienten mit höheren MHC-II-Proteinspiegeln zeigten fast die doppelte Ansprechrate im Vergleich zu nicht ausgewählten Patienten.
Die I-SPY 2-Studie, die sich auf Patienten mit hochriskantem Brustkrebs im Stadium II und III konzentriert, die eine neoadjuvante Therapie erhalten, ist eine multizentrische, adaptive Plattformstudie. Die Forschung deutet darauf hin, dass MHC-II-Tests die Versorgung erheblich verbessern könnten, indem sie präzisere Therapieentscheidungen ermöglichen, insbesondere bei Krebsarten, für die derzeit keine Biomarker-Tests verwendet werden.
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Golden, CO, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. (Nasdaq: BACK), today announced the presentation of new data demonstrating that MHC-II protein expression is a superior predictor of response to pembrolizumab (Keytruda®) compared to PD-L1 at the upcoming National Comprehensive Cancer Network (NCCN) Annual Conference. The study, conducted with I-SPY 2 clinical trial results, evaluated five different PD-L1 antibodies – including the one most commonly used as a companion diagnostic – yet only MHC-II expression showed a statistically significant correlation with patient outcomes.
“Although PD-L1 testing is standard in some cases, many patients end up on Keytruda without really benefiting,” said Faith Zaslavsky, CEO of Ignite Proteomics and IMAC Holdings. “Our analysis shows that measuring MHC-II levels does a better job of predicting who responds. For cancers types and stages with no biomarker testing at all, MHC-II would improve care by guiding therapy decisions more precisely.”
I-SPY 2 Trial Context
I-SPY 2 is a multicenter, adaptive platform trial primarily focused on high-risk stage II and III breast cancer patients undergoing neoadjuvant treatment. The design rapidly evaluates new agents – such as checkpoint inhibitors – based on interim outcomes like pathologic complete response. Data from I-SPY 2 often guides further clinical development in breast cancer, underscoring the significance of MHC-II outperforming PD-L1 measurements in this well-regarded research setting.
Key Findings
- Five PD-L1 Antibodies Tested: Only MHC-II correlated with response to pembrolizumab, whereas none of the five PD-L1 measurements reached statistical significance.
- Improved Patient Outcomes: Patients with higher MHC-II protein levels demonstrated nearly double the response rate compared to the unselected patient cohort.
- Unmet Need in Some Indications: For some cancers and settings where no biomarker testing is used, a large fraction of patients do not respond to checkpoint inhibitors. This study suggests MHC-II testing can enrich for those more likely to benefit.
About Ignite Proteomics
Ignite Proteomics, a subsidiary of IMAC Holdings (Nasdaq: BACK), leverages its unique, multi-analyte proteomic assay to help oncologists pinpoint the most effective targeted therapies for each patient. Operating under a CLIA-certified and CAP-accredited laboratory, Ignite goes beyond single-gene tests by evaluating entire protein pathways in cancer cells. The complex and interrelated output of the multi-analyte assay, driven by a proprietary, rules-based artificial intelligence engine, will result in significant advancements in matching cancer patients with the right medicine at the right time. Initially focused on advanced breast cancer, Ignite is rapidly expanding to other solid tumors and therapies whose effectiveness depends on protein function. By mapping which proteins are truly “active,” Ignite’s approach addresses a critical gap left by conventional genomic testing, ultimately improving treatment outcomes and reducing unnecessary costs.
Forward-Looking Statements
This press release may contain forward-looking statements, including those regarding the performance of Ignite’s tests and potential increases in clinical adoption. Actual results may differ materially from these statements due to various uncertainties. The Company disclaims any obligation to update forward-looking statements unless legally required.
Non-Scientific Summary
Many doctors use “PD-L1” tests to decide who should get Keytruda, but those tests may not always predict who will respond. In fact, some cancers do not use any test, even though a high number of patients don’t benefit. A new study analyzing data from the I-SPY 2 trial shows that measuring a protein called MHC-II can better identify which breast cancer patients truly respond to Keytruda, leading to more targeted and potentially more successful treatment. The data will be presented at the NCCN national conference.
Contact Information
Investors@imacholdings.com
www.igniteproteomics.com
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