Study Confirms the Ability of Castle Biosciences'; DecisionDx®-SCC Test to Predict Likelihood of Benefit from Adjuvant Radiation Therapy in Patients with High-Risk Cutaneous Squamous Cell Carcinoma
Castle Biosciences (Nasdaq: CSTL) has published a new study in Future Oncology validating the use of its DecisionDx-SCC test for guiding adjuvant radiation therapy (ART) decisions in high-risk cutaneous squamous cell carcinoma (SCC) patients. The study, involving 399 patients and 423 tumors, showed that:
1. Patients with Class 2B results (highest metastatic risk) treated with ART had a 50% decrease in metastatic disease progression.
2. Patients with Class 1 results (lowest metastatic risk) showed no difference in disease progression with or without ART, suggesting they may defer treatment.
3. Class 2A patients showed no significant benefit from ART despite intermediate risk levels.
This study corroborates findings from a recent 2024 study, further supporting DecisionDx-SCC's ability to improve risk-aligned patient care through precise, tumor-biology-based risk stratification.
Castle Biosciences (Nasdaq: CSTL) ha pubblicato un nuovo studio su Future Oncology che valida l'uso del suo test DecisionDx-SCC per guidare le decisioni sulla radioterapia adiuvante (ART) nei pazienti ad alto rischio di carcinoma squamoso cutaneo (SCC). Lo studio, che ha coinvolto 399 pazienti e 423 tumori, ha dimostrato che:
1. I pazienti con risultati di Classe 2B (rischio metastatico più alto) trattati con ART hanno registrato una riduzione del 50% nella progressione della malattia metastatica.
2. I pazienti con risultati di Classe 1 (rischio metastatico più basso) non hanno mostrato differenze nella progressione della malattia con o senza ART, suggerendo che potrebbero posticipare il trattamento.
3. I pazienti di Classe 2A non hanno mostrato benefici significativi dall'ART nonostante livelli di rischio intermedi.
Questo studio corroborà i risultati di un recente studio del 2024, supportando ulteriormente la capacità di DecisionDx-SCC di migliorare l'assistenza ai pazienti allineata al rischio attraverso una stratificazione del rischio precisa, basata sulla biologia tumorale.
Castle Biosciences (Nasdaq: CSTL) ha publicado un nuevo estudio en Future Oncology que valida el uso de su prueba DecisionDx-SCC para guiar las decisiones sobre la radioterapia adyuvante (ART) en pacientes de alto riesgo con carcinoma de células escamosas cutáneas (SCC). El estudio, que involucró a 399 pacientes y 423 tumores, mostró que:
1. Los pacientes con resultados de Clase 2B (el mayor riesgo metastásico) tratados con ART tuvieron una reducción del 50% en la progresión de la enfermedad metastásica.
2. Los pacientes con resultados de Clase 1 (el menor riesgo metastásico) no mostraron diferencias en la progresión de la enfermedad con o sin ART, lo que sugiere que podrían posponer el tratamiento.
3. Los pacientes de Clase 2A no mostraron beneficios significativos de la ART a pesar de tener niveles de riesgo intermedios.
Este estudio respalda los hallazgos de un estudio reciente de 2024, apoyando aún más la capacidad de DecisionDx-SCC para mejorar la atención personalizada de los pacientes mediante una estratificación de riesgos precisa basada en la biología del tumor.
Castle Biosciences (Nasdaq: CSTL)는 Future Oncology에 새로운 연구 결과를 발표하였으며, 이 연구는 고위험 피부 편평세포 암종(SCC) 환자에 대한 보조 방사선 치료(ART) 결정을 안내하기 위한 DecisionDx-SCC 테스트의 사용을 검증하였습니다. 399명의 환자와 423개의 종양이 포함된 이번 연구에서 다음과 같은 결과가 나타났습니다:
1. 클래스 2B 결과(메타스타시스 위험이 가장 높은) 환자들이 ART로 치료받았을 때 메타스타시스 질병 진행이 50% 감소했습니다.
2. 클래스 1 결과(가장 낮은 메타스타시스 위험) 환자들은 ART 시행 여부에 따른 질병 진행에 차이가 없이 치료를 연기할 수 있음을 시사하였습니다.
3. 클래스 2A 환자들은 중간 위험 수준에도 불구하고 ART로부터 유의미한 이점을 얻지 못했습니다.
이 연구는 2024년의 최근 연구 결과를 뒷받침하며, DecisionDx-SCC가 정밀한 종양 생물학 기반의 위험 stratification을 통해 위험을 조정한 환자 진료를 개선하는 능력을 더욱 확인시킵니다.
Castle Biosciences (Nasdaq: CSTL) a publié une nouvelle étude dans Future Oncology validant l'utilisation de son test DecisionDx-SCC pour guider les décisions de radiothérapie adjuvante (ART) chez les patients atteints de carcinome épidermoïde cutané (SCC) à haut risque. L'étude, impliquant 399 patients et 423 tumeurs, a montré que :
1. Les patients avec des résultats de Classe 2B (risque métastatique le plus élevé) traités par ART avaient une réduction de 50% de la progression de la maladie métastatique.
2. Les patients avec des résultats de Classe 1 (risque métastatique le plus bas) n'ont montré aucune différence dans la progression de la maladie avec ou sans ART, suggérant qu'ils pourraient différer le traitement.
3. Les patients de Classe 2A n'ont montré aucun avantage significatif de l'ART malgré des niveaux de risque intermédiaires.
Cette étude corrobore les résultats d'une étude récente de 2024, soutenant davantage la capacité de DecisionDx-SCC à améliorer les soins aux patients alignés sur les risques grâce à une stratification des risques précise, basée sur la biologie tumorale.
Castle Biosciences (Nasdaq: CSTL) hat eine neue Studie in Future Oncology veröffentlicht, die die Anwendung seines DecisionDx-SCC-Tests zur Unterstützung von Entscheidungen über adjuvante Strahlentherapie (ART) bei Patienten mit hohem Risiko für kutanen Plattenepithelkarzinom (SCC) validiert. Die Studie, die 399 Patienten und 423 Tumoren umfasste, zeigte Folgendes:
1. Patienten mit Ergebnissen der Klasse 2B (höchstes metastatisches Risiko), die mit ART behandelt wurden, hatten eine 50%ige Verringerung der Metastasierung.
2. Patienten mit Ergebnissen der Klasse 1 (niedrigstes metastatisches Risiko) zeigten keinen Unterschied in der Krankheitsprogression mit oder ohne ART, was darauf hindeutet, dass sie die Behandlung möglicherweise hinauszögern können.
3. Patienten der Klasse 2A wiesen trotz mittlerer Risikostufen keinen signifikanten Nutzen aus ART auf.
Diese Studie stützt die Ergebnisse einer kürzlich durchgeführten Studie aus 2024 und unterstreicht weiter die Fähigkeit von DecisionDx-SCC, die risikogerechte Patientenversorgung durch präzise, tumorspezifische Risikostratifizierung zu verbessern.
- DecisionDx-SCC test validated for guiding ART decisions in high-risk SCC patients
- 50% decrease in metastatic disease progression for Class 2B patients treated with ART
- Potential to avoid unnecessary ART for Class 1 patients
- Six studies since 2024 demonstrating DecisionDx-SCC's value in improving patient care
- Over 20 peer-reviewed papers supporting the test's validity since launch
- No significant benefit from ART observed for Class 2A patients
This study provides compelling evidence for the clinical utility of Castle Biosciences' DecisionDx-SCC test in guiding adjuvant radiation therapy (ART) decisions for high-risk cutaneous squamous cell carcinoma (SCC) patients. Key findings include:
- Patients with Class 2B results showed a
50% decrease in metastatic disease progression when treated with ART. - Class 1 patients showed no significant benefit from ART, suggesting they could potentially avoid unnecessary treatment.
- The test's ability to identify patients who would benefit from ART was validated in an independent cohort, strengthening its reliability.
These results could significantly impact treatment decisions, potentially reducing overtreatment in low-risk patients while ensuring high-risk patients receive appropriate therapy. The study's alignment with previous research further bolsters the test's credibility in the oncology community.
This study has positive implications for Castle Biosciences (NASDAQ: CSTL). The validation of DecisionDx-SCC's ability to guide ART decisions in an independent cohort strengthens its market position. Key financial considerations include:
- Potential for increased adoption of the test by oncologists and dermatologists, driving revenue growth.
- Enhanced reimbursement prospects as the test demonstrates clear clinical utility.
- Competitive advantage in the precision oncology diagnostics market.
With six supportive studies published in 2024 alone, Castle Biosciences is building a robust evidence base that could translate into stronger market penetration and improved financial performance. Investors should monitor adoption rates and reimbursement decisions as indicators of the test's commercial success.
This is the second study to demonstrate the ability of the DecisionDx-SCC test to identify patients who are more or less likely to benefit from adjuvant radiation therapy (ART), confirmed in an independent cohort of high-risk cutaneous squamous cell carcinoma (SCC) patients
“Some patients with high-risk SCC are eligible for adjuvant radiation therapy once their primary tumor has been removed; however, determining which patients should seek treatment is complicated and involves weighing numerous pros and cons against the risk of the patient’s cancer returning,” said Emily S. Ruiz, M.D., MPH, FAAD, lead author, board-certified dermatologist and Mohs micrographic surgeon at Brigham and Women’s Hospital in
In the study, a novel, independent cohort of patients with high-risk SCC tumors (399 patients; 423 tumors) from two academic centers were tested using DecisionDx-SCC and analyzed for five-year metastasis-free survival and projected time to metastasis. Similar to the recent 2024 study by Arron et al., samples were controlled for bias by clinicopathologically matching ART-treated and untreated patients.1
A comparison of both studies (Arron et al. and Ruiz et al.) demonstrates very similar results:
-
Both studies showed that patients with DecisionDx-SCC Class 2B (highest metastatic risk) test results who were treated with ART had a
50% decrease in metastatic disease progression, on average, and a significant deceleration of disease progression compared to patients who did not receive ART. - Both studies reported no difference in disease progression rates when comparing ART-treated and untreated patients with DecisionDx-SCC Class 1 (lowest metastatic risk) test results, suggesting these patients may consider deferring treatment due to low metastatic risk and a low likelihood of benefitting from treatment. The majority of patients had Class 1 results, confirming the significance of clinical utility in ruling out ART in these patients.
- Additionally, both studies observed a lack of ART-related benefit for patients with Class 2A (higher metastatic risk) test results, despite having an intermediate-level risk of metastasis compared to patients with Class 1 and Class 2B test results. This suggests that a specific pattern of gene expression captured uniquely by a DecisionDx-SCC Class 2B result may be driving the identification of the benefit from ART.
“This marks the sixth study since the start of 2024 demonstrating the value of DecisionDx-SCC test results in improving risk-aligned patient care through precise, tumor-biology-based risk stratification,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “The more than 20 peer-reviewed papers published since the launch of our test four years ago speaks to the breadth of evidence supporting the test’s validity, as well as its ability to improve upon clinicopathologic-based staging systems to drive optimized decision-making regarding appropriate treatment pathways for patients with high-risk SCC.”
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 guide patient selection and decision-making related to the use of ART in patients with high-risk SCC. 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.
- 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
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Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
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