New Data at ASTRO 2024 Shows Castle Biosciences’ DecisionDx®-SCC Test Provides More Precise Risk Stratification Than BWH Staging Alone to Guide Intensified Treatment for Immune Suppressed Patients with High-Risk Cutaneous Squamous Cell Carcinoma
Castle Biosciences (Nasdaq: CSTL) announced new data demonstrating the effectiveness of its DecisionDx-SCC test in risk stratification for high-risk cutaneous squamous cell carcinoma (SCC) patients, particularly those with suppressed immune systems. The data, to be presented at the ASTRO 2024 Annual Meeting, shows that the test can guide treatment intensification decisions, such as adjuvant radiation therapy.
The study analyzed 954 SCC patients with at least one NCCN high-risk factor. For patients with BWH T1 tumors, the DecisionDx-SCC test further stratified risk regardless of immune status. For immune suppressed patients with T2a tumors, the test identified those with more favorable (Class 1) and less favorable (Class 2A/2B) survival rates. The results suggest that treatment intensification should be considered for immune suppressed patients with BWH T2a SCC tumors, guided by DecisionDx-SCC test results.
Castle Biosciences (Nasdaq: CSTL) ha annunciato nuovi dati che dimostrano l'efficacia del suo test DecisionDx-SCC nella stratificazione del rischio per i pazienti con carcinoma cutaneo a cellule squamose (SCC) ad alto rischio, in particolare per quelli con sistemi immunitari compromessi. I dati, che saranno presentati al Meeting Annuale ASTRO 2024, mostrano che il test può guidare le decisioni di intensificazione del trattamento, come la radioterapia adiuvante.
Lo studio ha analizzato 954 pazienti con SCC con almeno un fattore di rischio NCCN ad alto rischio. Per i pazienti con tumori BWH T1, il test DecisionDx-SCC ha ulteriormente stratificato il rischio indipendentemente dallo stato immunitario. Per i pazienti immunocompromessi con tumori T2a, il test ha identificato quelli con tassi di sopravvivenza più favorevoli (Classe 1) e meno favorevoli (Classe 2A/2B). I risultati suggeriscono che si dovrebbe considerare l'intensificazione del trattamento per i pazienti immunocompromessi con tumori SCC BWH T2a, guidati dai risultati del test DecisionDx-SCC.
Castle Biosciences (Nasdaq: CSTL) anunció nuevos datos que demuestran la efectividad de su prueba DecisionDx-SCC en la estratificación del riesgo para pacientes con carcinoma cutáneo de células escamosas (SCC) de alto riesgo, especialmente aquellos con sistemas inmunitarios suprimidos. Los datos, que se presentarán en la Reunión Anual ASTRO 2024, muestran que la prueba puede guiar las decisiones de intensificación del tratamiento, como la radioterapia adyuvante.
El estudio analizó 954 pacientes con SCC que tenían al menos un factor de riesgo de alto riesgo según NCCN. Para pacientes con tumores BWH T1, la prueba DecisionDx-SCC estratificó aún más el riesgo sin importar el estado inmunológico. Para los pacientes inmunosuprimidos con tumores T2a, la prueba identificó a aquellos con tasas de supervivencia más favorables (Clase 1) y menos favorables (Clase 2A/2B). Los resultados sugieren que se debería considerar la intensificación del tratamiento para los pacientes inmunosuprimidos con tumores SCC BWH T2a, guiados por los resultados de la prueba DecisionDx-SCC.
Castle Biosciences (Nasdaq: CSTL)는 면역 체계가 억제된 고위험 피부 편평 세포 암(SCC) 환자에 대한 위험 분류에서 DecisionDx-SCC 테스트의 효과를 입증하는 새로운 데이터를 발표했습니다. ASTRO 2024 연례 회의에서 발표될 이 데이터는 이 테스트가 보조 방사선 치료와 같은 치료 강화 결정을 안내하는 데 도움이 될 수 있음을 보여줍니다.
이 연구는 NCCN 고위험 요소를 최소한 하나 가진 954명의 SCC 환자를 분석했습니다. BWH T1 종양을 가진 환자의 경우, DecisionDx-SCC 테스트는 면역 상태와 관계없이 위험을 추가로 분류했습니다. T2a 종양을 가지고 있는 면역 억제 환자의 경우, 이 테스트는 더 유리한(클래스 1) 및 덜 유리한(클래스 2A/2B) 생존율을 가진 환자를 식별했습니다. 결과는 BWH T2a SCC 종양을 가진 면역 억제 환자에게 DecisionDx-SCC 테스트 결과에 따라 치료 강화를 고려해야 함을 시사합니다.
Castle Biosciences (Nasdaq: CSTL) a annoncé de nouvelles données montrant l'efficacité de son test DecisionDx-SCC dans la stratification des risques pour les patients atteints de carcinome à cellules squameuses cutanées (SCC) à haut risque, en particulier ceux avec un système immunitaire affaibli. Les données, qui seront présentées lors de la Réunion Annuelle ASTRO 2024, montrent que le test peut guider les décisions d'intensification du traitement, comme la radiothérapie adjuvante.
L'étude a analysé 954 patients atteints de SCC ayant au moins un facteur de risque NCCN élevé. Pour les patients atteints de tumeurs BWH T1, le test DecisionDx-SCC a stratifié davantage le risque indépendamment du statut immunitaire. Pour les patients immunodéprimés avec des tumeurs T2a, le test a identifié ceux ayant des taux de survie plus favorables (Classe 1) et moins favorables (Classe 2A/2B). Les résultats suggèrent que l'intensification du traitement devrait être envisagée pour les patients immunodéprimés ayant des tumeurs SCC BWH T2a, guidée par les résultats du test DecisionDx-SCC.
Castle Biosciences (Nasdaq: CSTL) hat neue Daten veröffentlicht, die die Wirksamkeit des DecisionDx-SCC-Tests bei der Risikostratifizierung von Patienten mit hohem Risiko für kutane Plattenepithelkarzinome (SCC) zeigen, insbesondere bei Patienten mit unterdrücktem Immunsystem. Die Daten, die auf dem ASTRO 2024 Jahresmeeting präsentiert werden, zeigen, dass der Test die Entscheidungen zur Intensivierung der Behandlung, wie die adjuvante Strahlentherapie, leiten kann.
In der Studie wurden 954 SCC-Patienten mit mindestens einem NCCN-Hochrisikofaktor analysiert. Bei Patienten mit BWH T1-Tumoren hat der DecisionDx-SCC-Test das Risiko unabhängig vom Immunstatus weiter stratifiziert. Bei immunsupprimierten Patienten mit T2a-Tumoren identifizierte der Test solche mit günstigeren (Klasse 1) und ungünstigeren (Klasse 2A/2B) Überlebensraten. Die Ergebnisse deuten darauf hin, dass eine Intensivierung der Behandlung bei immunsupprimierten Patienten mit BWH T2a SCC-Tumoren in Betracht gezogen werden sollte, geleitet durch die Ergebnisse des DecisionDx-SCC-Tests.
- DecisionDx-SCC test demonstrated ability to provide clinically impactful risk stratification in high-risk SCC patient sub-populations
- Test results can guide potential treatment intensification decisions, such as adjuvant radiation therapy
- Study showed DecisionDx-SCC test further stratified risk for patients with BWH T1 tumors, regardless of immune status
- For immune suppressed patients with T2a tumors, the test identified those with more favorable and less favorable survival rates
- Immune suppressed patients with T2a tumors had significantly worse metastasis-free survival compared to immune competent patients (71.4% vs. 91.2%)
Insights
The new data on Castle Biosciences' DecisionDx-SCC test demonstrates significant clinical utility for patients with high-risk cutaneous squamous cell carcinoma (SCC), particularly those who are immunosuppressed. The test's ability to stratify patients beyond traditional staging methods is important for personalized treatment decisions.
Key findings include:
- For BWH T1 tumors, DecisionDx-SCC further stratified patients regardless of immune status (3-year MFS: Class 1:
96.9% vs. Class 2A/2B:88.6% , p<0.001). - Immunosuppressed patients with T2a tumors showed significantly worse metastasis-free survival (MFS) compared to immunocompetent patients (
71.4% vs.91.2% , p<0.001). - DecisionDx-SCC further stratified immunosuppressed T2a patients into more favorable (Class 1; 3-yr MFS of
83% ) and less favorable (Class 2A/2B; 3-yr MFS of57% ) survival groups.
This enhanced risk stratification could lead to more precise treatment planning, potentially improving patient outcomes and resource allocation in oncology care. The data suggests that adjuvant radiation therapy should be strongly considered for immunosuppressed patients with BWH T2a SCC tumors, guided by DecisionDx-SCC results.
The presentation of this data at ASTRO 2024 is likely to bolster Castle Biosciences' market position in precision oncology diagnostics. The DecisionDx-SCC test's demonstrated ability to provide more precise risk stratification than traditional staging methods could drive increased adoption among oncologists and dermatologists, potentially leading to higher test volumes and revenue growth for CSTL.
Key financial implications include:
- Potential expansion of the addressable market, particularly in the high-risk and immunosuppressed patient segments
- Increased reimbursement opportunities as the test demonstrates clinical utility in guiding treatment decisions
- Possible strengthening of CSTL's competitive position in the skin cancer diagnostics market
While specific revenue projections are not provided, the positive clinical data could translate to improved financial performance for Castle Biosciences in the medium to long term. Investors should monitor future earnings reports for indications of increased test adoption and revenue growth related to DecisionDx-SCC.
In the study, patients with lower-stage Brigham and Women's Hospital (BWH) T1-T2a cutaneous squamous cell carcinoma (SCC) tumors were further stratified into distinct groups of those with more or less favorable survival by the DecisionDx-SCC test, including in the T2a immunosuppressed patient subset which showed a higher rate of metastasis
“The DecisionDx-SCC test has been validated to independently predict likelihood of metastasis beyond staging and clinicopathologic risk factors to help inform important treatment decisions for patients with SCC,” said Shlomo A. Koyfman, M.D., lead study author and radiation oncologist at Cleveland Clinic.1-3 “The data we are sharing at ASTRO highlights the utility of the test in immune suppressed patients with lower-stage SCC tumors, who may have an elevated risk of metastasis due to their immune status and thus may benefit from intensified surveillance and adjuvant treatments, such as radiation, following tumor removal to reduce this risk.”4,5
Details regarding Castle’s oral presentation at ASTRO are included below:
- Abstract title: Use of the 40-gene expression profile (40-GEP) test to identify immune suppressed patients with Brigham and Women’s Hospital (BWH) T1-T2a cutaneous squamous cell carcinoma (cSCC) at higher risk of metastasis: Implications for adjuvant radiation
- Abstract ID: 1065
- Lead Authors: Shlomo A. Koyfman, M.D., and Karina Brito, Cleveland Clinic
- Session Type: Quick Pitch
- Session: QP 12 - Sarcoma 2: Advancing Treatment Frontiers in Cutaneous Malignancies and Sarcoma
- Date & Time: Tuesday, Oct. 1, 2:30-2:40 p.m. Eastern Time
- Location: Room 151
-
Summary: Data from an independent validation cohort of 954 SCC patients with at least one National Comprehensive Cancer Network (NCCN) high-risk factor and DecisionDx-SCC test results were analyzed for patients with BWH T1 and T2a tumors with no residual tumor after Mohs surgery; 441 patients with BWH T1 tumors and 336 with BWH T2a tumors were included in the study cohort. Patients with T1 tumors had similar metastasis-free survival (MFS) rates regardless of immune status yet were further stratified by their DecisionDx-SCC test result (3-year MFS: Class 1 test result:
96.9% vs. Class 2A/2B test result:88.6% , p<0.001). Immune suppressed patients with T2a tumors had significantly worse MFS than immune competent patients with T2a tumors (71.4% vs.91.2% , p<0.001). DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of83% ) and less favorable survival (Class 2A/2B test result; 3-yr MFS of57% ). Given the study data, treatment intensification such as ART should be strongly considered in immune suppressed patients with BWH T2a SCC tumors guided by DecisionDx-SCC test results.
The full text abstract is available in the ASTRO Annual Meeting Portal and will be published in the International Journal of Radiation Oncology • Biology • Physics (Red Journal).
About DecisionDx-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.
Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the continued ability of the DecisionDx-SCC test to provide more precise risk stratification than BWH staging alone to guide potential treatment intensification in patients with high-risk SCC; and Castle’s ability to meaningfully improve the care of patients with high-risk SCC through its DecisionDx-SCC test. The words “can,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of DecisionDx-SCC in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.
- Wysong A, Newman JG, Covington KR, et al. Validation of a 40-gene expression profile test to predict metastatic risk in localized high-risk cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2021;84(2):361–9. https://doi.org/10.1016/j.jaad.2020.04.088.
- Ibrahim SF, Kasprzak JM, Hall MA, et al. Enhanced metastatic risk assessment in cutaneous squamous cell carcinoma with the 40-gene expression profile test. Future Oncol. 2022;18(7):833–47. https://doi.org/10.2217/fon-2021-1277.
- Wysong A, Somani AK, Ibrahim SF, et al. Integrating the 40-gene expression profile (40-GEP) test improves metastatic risk-stratification within clinically relevant subgroups of high-risk cutaneous squamous cell carcinoma (cSCC) patients. Dermatol Ther (Heidelb). 2024. https://doi.org/10.1007/s13555-024-01111-5
- Arron ST, Cañueto J, Siegel J, et al. Association of a 40-gene expression profile with risk of metastatic disease progression of cutaneous squamous cell carcinoma (cSCC) and specification of benefit of adjuvant radiation therapy. IJROBP. 2024. doi: https://doi.org/10.1016/j.ijrobp.2024.05.022
- Ruiz ES, Brito K, Karn EE, et al. Predicting adjuvant radiation therapy benefit in cutaneous squamous cell carcinoma with the 40-gene expression profile. Future Oncol. 2024. doi: https://doi.org/10.1080/14796694.2024.2390820
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Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
FAQ
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