TEST:

DecisionDx®-UM

P=NA | N=876 | "The data show DecisionDx-Melanoma stratified patients by their risk of recurrence and was a significant predictor of recurrence; patients with Class 1A (lowest risk) test results had significantly higher three-year recurrence-free survival than those with a Class 1B/2A (increased risk) or Class 2B (highest risk) test result (p<0.001). Importantly, the test added significant predictive value to American Joint Committee on Cancer (AJCC) staging, considered the standard of care in melanoma management. These findings provide evidence that use of the test with melanoma patients enables better risk-aligned care decisions, which have been shown to lead to improved patient outcomes."

"Castle Biosciences, Inc...today announced that it will present new data related to its DecisionDx-Melanoma and DecisionDx® -UM tests for patients with cutaneous melanoma (CM) and uveal melanoma (UM), respectively, at the 21st International Congress of the Society for Melanoma Research (SMR), taking place Oct. 10-13, 2024, in New Orleans."

In the largest prospective multicenter prognostic biomarker study performed to date in UM to our knowledge, the COOG2 study validated the superior prognostic accuracy of the integrated 15-GEP/PRAME classifier over 15-GEP alone and clinical prognostic variables. Tumor diameter was found to be the only clinical variable to provide additional prognostic information. This prognostic classifier provides an advanced resource for risk-adjusted metastatic surveillance and adjuvant trial stratification in patients with UM.

"Castle Biosciences...announced that it will present new data related to its DecisionDx-Melanoma and DecisionDx-UM tests at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31-June 4, 2024, in Chicago."

P=NA | N=1,586 | "Castle Biosciences...announced new data from a study further confirming the performance of its DecisionDx-UM test as a robust independent predictor of metastasis-free survival (MFS) in patients diagnosed with UM....The data was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting....In the study, a DecisionDx-UM Class 2 result was the most robust independent predictor of MFS (HR 6.03; 95% CI, 4.49-8.09); P<0.001), followed by PRAME status (HR 1.77; 95% CI, 1.39-2.27; P<0.001). Patients with Class 2 tumors had considerably worse outcomes than those with Class 1 tumors, regardless of PRAME status; however, PRAME+ tumors fared worse within each GEP class (versus PRAME-). When considered together, five-year MFS rates were 95.6% (95% CI, 93.9-97.4) for Class 1/PRAME-, 80.6% (73.9-87.9) for Class 1/PRAME+, 57.6% (50.6-65.7) for Class 2/PRAME- and 44.8% (38.0-52.8) for Class 2/PRAME+."

This phase II study of adjuvant Nivo/Ipi resulted in clinically meaningful and statistically significant improvement in 3-year DMFS of 70.4% vs 43.4% in control for pts with high-risk UM from the COOG database matched for tumor characteristics. Further investigation of this regimen as adjuvant therapy of high-risk UM is warranted.

The validated PRAME and NGS tests described here, which can be performed from the same initial biopsy sample taken for 15-GEP testing, provide results that are not systematically associated with 15-GEP class. Given that the 15-GEP has been shown to be superior to both PRAME and NGS in predicting metastatic outcomes, it is recommended that these supplemental tests only be considered in the context of a 15-GEP test result to prevent potentially over or under identifying high-risk biology. An ongoing prospective study with long term outcomes for over 1700 UM patients led by the Collaborative Ocular Oncology Group (COOG2) will provide insight into how best to effectively integrate these supplementary biomarkers with the 15-GEP class result.

There were no significant differences in time to metastasis diagnosis and survival outcomes in patients with and without GEP. To realize the full benefit of GEP, more sensitive techniques for detection of metastasis and adjuvant therapies are required.

"Castle Biosciences, Inc...announced new discovery data from an ongoing study exploring the potential for developing a complementary, minimally invasive test to evaluate small, suspicious lesions of uncertain malignant potential in patients eyes."

No abstract available

"Castle Biosciences, Inc...announced that new data on DecisionDx®-Melanoma and DecisionDx®-UM will be shared during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6."

Melanoma polypeptide vaccines are immunogenic and safe in patients with uveal melanoma. Our early data suggests the possibility of early benefit with direct antigen response, though longer follow up and further study will be needed to investigate these findings.

In this analysis, the 15-GEP accurately stratified risk of death from UM in a clinically tested, population-based cohort of patients, confirming previous studies. Socioeconomic status did not impact the likelihood of getting a high-risk result, suggesting equitable access to care for patients who receive 15-GEP testing. Ongoing analyses of SEER-linked UM data will include patients who received a PRAME test result, allowing for assessment of this adjunctive biomarker in combination with the 15-GEP result.

"Castle Biosciences, Inc...announced the publication of a study completed in collaboration with the Melanoma Research Foundation (MRF) in which most patients diagnosed with uveal melanoma (UM) indicated their desire for prognostic testing at diagnosis, reported finding value in their test result and experienced lower decision regret, regardless of whether their test result indicated that their UM tumor was at a high or low risk of metastasis...Highlights from the study include the following...Patients who received a low-risk (Class 1A) DecisionDx-UM result were 10 times more likely than those who received a high-risk (Class 2) result to report gaining a 'sense of relief from uncertainty about the future.' (X2=11, df=1, p=0.0009). Conversely, a majority of patients who received a high-risk (Class 2) result reported that their test result provided them 'increased knowledge and understanding' about their disease (X2=17.48, df=3, p=0.0006)."

P=NA | N=4,687 | "In the study, DecisionDx-Melanoma was a statistically significant and independent predictor of melanoma-specific survival (MSS), consistent with previously published retrospective and prospective studies. Patients with stage IIB or IIC melanoma and a low-risk (Class 1A) DecisionDx-Melanoma test result had higher three-year MSS than patients with a high-risk (Class 2B) result (Class 1A: 100% vs. Class 2B: 88.3%, p=0.04); similar results were observed for patients with stage III CM (Class 1A: 96.1% vs. Class 2B; 79.6%, p=0.03). Additionally, DecisionDx-Melanoma was a statistically significant and independent predictor of MSS across all stages of disease, with a hazard ratio of 7.00 for the Class 2B result."

Since most patients in this cohort were symptomatic, the incidence of asymptomatic BM remains unknown. These data suggest the use of routine brain imaging in all mUM patients at risk for developing BM for early detection.

Decision regret did not differ based on GEP class. Most uveal melanoma patients desire prognostic testing and gain value from the GEP, independent of a high- or low-risk result.

"Castle Biosciences, Inc...announced findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM®. Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands."

P=N/A; Active, not recruiting --> Completed | N=2800 --> 93

Six months of adjuvant sunitinib or VPA resulted in 2-year OS of 95.6% and 90.7%, respectively, meeting the primary endpoint of the study. Sunitinib showed a tendency for a better outcome until 3 years after randomization, thus Cohort 2 was created to investigate the safety and prolonged improvement of RFS and OS with 12 months of sunitinib. Additionally, Cohort 3 with adjuvant sunitinib in combination with VPA for 12 months is currently ongoing.

"Castle Biosciences...announced the publication of a study demonstrating that the combined application of DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq allows for highly accurate analysis of RNA and DNA from a single biopsy sample for patients with uveal melanoma (UM)...The study titled, 'Analytical validation and performance of a 7-gene next-generation sequencing panel in uveal melanoma' was recently published in the peer-reviewed journal Ocular Oncology and Pathology."

P=N/A; Trial completion date: Oct 2020 --> Feb 2022 | Trial primary completion date: Oct 2020 --> Feb 2022