Tempus Announces the Clinical Launch of its Immune Profile Score Algorithmic Test
Tempus announced the clinical launch of its Immune Profile Score (IPS) algorithmic test, a multimodal biomarker for adult patients with stage IV and metastatic pan-solid tumors who are candidates for immune checkpoint inhibitor therapy. The validation study, involving 1,600 patients with 19 different solid tumor types, showed that IPS-High patients were more likely to have better overall survival while receiving ICI-based therapy compared to IPS-Low patients (HR 0.45). The test calculates a score from 0-100 and provides IPS-Low or IPS-High classification, operating independently of tumor mutational burden, PD-L1 immunohistochemistry, and microsatellite instability status.
Tempus ha annunciato il lancio clinico del suo test algoritmico Immune Profile Score (IPS), un biomarcatore multimodale per i pazienti adulti con tumori solidi metastatici di stadio IV che sono candidati alla terapia con inibitori del checkpoint immunitario. Lo studio di validazione, che ha coinvolto 1.600 pazienti con 19 diversi tipi di tumori solidi, ha mostrato che i pazienti IPS-Alti avevano maggiori probabilità di avere una migliore sopravvivenza globale durante il trattamento basato su ICI rispetto ai pazienti IPS-Bassi (HR 0,45). Il test calcola un punteggio da 0 a 100 e fornisce una classificazione IPS-Basso o IPS-Alto, operando in modo indipendente dal carico mutazionale tumorale, dall'immunoistochimica PD-L1 e dallo stato di instabilità dei microsatelliti.
Tempus anunció el lanzamiento clínico de su prueba algorítmica Immune Profile Score (IPS), un biomarcador multimodal para pacientes adultos con tumores sólidos de estadio IV metastásicos que son candidatos a terapia con inhibidores del punto de control inmunitario. El estudio de validación, que involucró a 1,600 pacientes con 19 tipos diferentes de tumores sólidos, mostró que los pacientes IPS-Alto tenían más probabilidades de tener una mejor supervivencia general mientras recibían terapia basada en ICI en comparación con los pacientes IPS-Bajo (HR 0.45). La prueba calcula una puntuación de 0 a 100 y proporciona una clasificación IPS-Bajo o IPS-Alto, operando de manera independiente de la carga mutacional tumoral, la inmunohistoquímica de PD-L1 y el estado de inestabilidad de microsatélites.
템퍼스는 알고리즘 테스트인 면역 프로필 점수(IPS)의 임상 출시를 발표했습니다. 이 테스트는 면역 체크포인트 억제제 치료의 후보인 4기 및 전이성 고형 종양을 가진 성인 환자용 다중 생물 마커입니다. 1,600명의 환자와 19종의 다양한 고형 종양을 포함한 검증 연구는 IPS-높은 환자들이 IPS-낮은 환자들에 비해 ICI 기반 치료 중 전체 생존율이 더 높다는 것을 보여주었습니다 (HR 0.45). 이 테스트는 0에서 100까지의 점수를 계산하고 IPS-낮음이나 IPS-높음으로 분류하며, 종양 변이 부담, PD-L1 면역 조직 화학 및 마이크로새틀라이트 불안정성 상태와는 독립적으로 작동합니다.
Tempus a annoncé le lancement clinique de son test algorithmique Immune Profile Score (IPS), un biomarqueur multimodal pour les patients adultes atteints de tumeurs solides métastatiques de stade IV, candidats à une thérapie par inhibiteurs de point de contrôle immunitaire. L'étude de validation, impliquant 1 600 patients avec 19 types différents de tumeurs solides, a montré que les patients IPS-Élevés étaient plus susceptibles d'avoir une meilleure survie globale pendant qu'ils recevaient une thérapie basée sur l'ICI par rapport aux patients IPS-Bas (HR 0,45). Le test calcule un score de 0 à 100 et fournit une classification IPS-Bas ou IPS-Élevé, opérant indépendamment de la charge mutationnelle tumorale, de l'immunohistochimie PD-L1 et du statut d'instabilité des microsatellites.
Tempus hat den klinischen Start seines algorithmischen Tests Immune Profile Score (IPS) angekündigt, einem multimodalen Biomarker für erwachsene Patienten mit fortgeschrittenen metastaticen soliden Tumoren des Stadiums IV, die Kandidaten für eine Therapie mit immuncheckpoint-Inhibitoren sind. Die Validierungsstudie, an der 1.600 Patienten mit 19 verschiedenen soliden Tumortypen teilnahmen, zeigte, dass IPS-hohe Patienten eine höhere Wahrscheinlichkeit hatten, eine bessere Gesamtüberlebensrate zu erreichen, während sie eine ICI-basierte Therapie erhielten, im Vergleich zu IPS-niedrigen Patienten (HR 0,45). Der Test berechnet einen Score von 0 bis 100 und bietet eine Klassifizierung als IPS-niedrig oder IPS-hoch, wobei er unabhängig von der tumoralen Mutationslast, der PD-L1-Immunhistochemie und dem Mikrosatelliteninstabilitätsstatus funktioniert.
- Successful validation study with 1,600 patients showing significant survival benefit (HR 0.45) for IPS-High patients
- Test operates independently of existing biomarkers, offering additional clinical value
- Commercial launch enables immediate revenue generation potential
- Expansion into immunotherapy market with first multimodal algorithm
- None.
Insights
The clinical launch of Tempus' Immune Profile Score (IPS) test represents a significant advancement in precision oncology. The validation study's results showing a hazard ratio of 0.45 for IPS-High patients indicates substantially better survival outcomes for this group when treated with immune checkpoint inhibitors. The test's ability to work independently of existing biomarkers (TMB, PD-L1 and MSI) adds a valuable new layer to treatment decision-making.
The large-scale validation study involving 1,600 patients across 19 solid tumor types provides robust evidence for the test's clinical utility. This multimodal approach, combining DNA and RNA analysis to generate a 0-100 score, could significantly improve patient selection for immunotherapy treatments, potentially leading to better resource allocation and improved treatment outcomes.
The launch of IPS positions Tempus strategically in the growing precision medicine market. By offering this test as an add-on to existing xT and xR assays, the company creates an additional revenue stream while increasing the value proposition of its core testing services. The test's dual utility in both clinical practice and life science research opens multiple market opportunities, particularly in drug development partnerships and clinical trial optimization.
The independent validation from prominent institutions and the test's ability to provide unique insights beyond standard biomarkers strengthens Tempus' competitive position in the precision oncology space. This could drive adoption among oncologists and potentially lead to increased market share in the molecular diagnostics sector.
IPS test validation study data will be unveiled at the 2024 SITC Annual Meeting
Tempus validated IPS in a retrospective study involving 1,600 metastatic and/or stage IV adult patients with 19 different solid tumor types from the company’s real-world de-identified database. The study also demonstrated that IPS has prognostic utility that is independent of tumor mutational burden (TMB), PD-L1 immunohistochemistry (IHC), and microsatellite instability (MSI) status in the study cohort. Tempus’ IPS is a laboratory developed test that assesses a combination of immunotherapy-related biomarkers from DNA and RNA test results to calculate a score from 0-100 and a classification of either IPS-Low or IPS-High. IPS is a unique biomarker that, in addition to being used in clinical practice, is available for life science research to help facilitate the expansion of indications for ICI therapies in order to enhance patient selection and treatment outcomes.
"This is Tempus’ first time leveraging a multimodal algorithm in the immunotherapy space, and we look forward to providing clinicians the ability to use our IPS test to garner data-driven insights that can inform important treatment decisions," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "We are excited to introduce this innovative test to clinicians, empowering them with the ability to make more informed choices for their patients while simultaneously moving the field forward in meaningful ways."
"This study demonstrates that IPS scoring is beneficial in that it can identify patients, independent of standard biomarkers, who may have better overall survival with ICI therapy," said Sandip Patel, MD, Professor at UC San Diego Health. "IPS scoring can inform tumor-intrinsic sensitivity to immune checkpoint blockade beyond PD-L1 IHC and TMB, and help manage patients on immunotherapy utilizing data already collected as part of DNA and RNA sequencing."
The IPS test is now available as an add-on option for clinicians ordering Tempus’ xT (DNA) and xR (RNA) assays. For more information on the validation study, visit tempus.com/publications.
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential impact and uses of IPS and other tests. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
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Tempus Communications
Erin Carron
media@tempus.com
Source: Tempus AI, Inc.
FAQ
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