On April 13, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in molecular profiling tests, early cancer screening products and companion diagnostics development, reported the release of 22 research results at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (AACR 2021) (Press release, Genetron Health Technologies, APR 13, 2021, View Source [SID1234577985]).

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The results were from a series of studies that Genetron Health conducted with 13 leading hospitals in China. The Company leveraged original research and innovative technologies such as integrated DNA and RNA sequencing in gene fusion detection, a new MSI (microsatellite instability) detection algorithm model, its "One-Step Seq" method, and core products such as Onco Panscan and comprehensive sarcoma gene detection tests.

These studies analyzed the spread of various types of cancers throughout the Chinese population, covering lung cancer, intestinal cancer, pancreatic cancer, nervous system tumors, thymic carcinoma, and other types of cancers. More specifically, the studies focused on these cancers’ inheritance, mutation, and fusion characteristics. They paid particular attention to the validity of immunotherapy markers for various types of cancers, as well as rare cancer cases and new therapeutic treatments. These studies provided important insights that can enable the accurate diagnosis and treatment of cancer, facilitating the design of effective products in the future.

Dr. Yunfu Hu, Genetron Health’s Chief Medical Officer, said, "Genetron Health is committed to building a strong bridge between scientific research and clinical applications. The studies’ results show that the Company’s innovative technologies and products can help to further analyze the characteristics of cancer genomics for different types of cancer, optimize conventional technologies, and provide ideas for new product design, so as to promote the healthy development of translational medicine. For example, for soft tissue sarcoma (STS), the use of integrated DNA and RNA sequencing in gene fusion detection can greatly improve the detection rate of STS gene fusion, which may benefit more STS patients.

"For hereditary cancers, the screening method used to detect Li-Fraumeni syndrome will also improve cancer detection rates in these patients and provide more intervention opportunities for them; for colorectal cancer, our analysis of KMT2C/2D inactivation mutations is also pointing to more possibilities for immunotherapy patients. And lastly, our work on rare cancer cases and the experimentation of new treatments is furthering the development of diagnosis and treatment research for these various types of patients," Hu added.

Exploring Ways to Optimize Conventional Technologies

To overcome the DNA-sequencing limitations involved with detecting gene fusion, Genetron Health optimized the use of conventional technologies in Study #2288. During this study, more accurate, efficient, and low-cost detection of gene fusion mutations was achieved at the RNA sequencing level. This was evaluated and verified in a STS cohort of 142 Chinese patients. Compared with DNA detection alone, integrated DNA and RNA sequencing improved the detection rate of STS fusion by 177%, which could provide clinical benefits for more STS patients.

Study #2080 optimized the algorithm that detects MSI through next generation sequencing (NGS). The study was conducted on a large cohort of 2,523 samples with various types of cancers. According to the study results, the optimized algorithm was 99.9% consistent with PCR (polymerase chain reaction) testing – the industry’s current gold standard. The positive predictive value of MSI-H was 98.73%, and the negative predictive value of MSS was 99.92%.

Focusing on Hereditary Cancers

Two studies (#1464, #2557) provided screening methods for Li-Fraumeni syndrome, an inherited condition that is characterized by an increased risk for certain types of cancer. These methods utilized in-depth analysis of germline mutations and investigated the distribution of genetic characteristics for pancreatic cancer in the Chinese population, providing evidence and additional ideas for the diagnosis and treatment of hereditary cancers.

Investigating Gene Mutation and Fusion Characteristics

Nine studies (#2217, #2163, #2223, #2216, #2215, #2313, #2252, #2183, #2182) examined the mutation and fusion characteristics of soft tissue sarcoma, melanoma, neuroendocrine tumors, non-small cell lung cancer, thymic carcinoma, small bowel adenocarcinoma, ampullary carcinoma, etc. The studies focused on finding potential targets for precise therapeutic treatment, drug-resistant targets and effective countermeasures.

Probing Immunotherapy Markers

Four studies (#1639, #1640, #1641, #1681) investigated the predictive effects of KMT2C/D loss-of-function mutations, DDR signaling pathway-related gene mutations, ARID1A mutations, and BRCA1/2 mutations on immunotherapy treatments for a wide range of cancer types, providing further insights.

Spotlight on Rare Cancer Cases and New Treatment Therapies

Five studies (#0803, #0422, #1209, #1199, #0625) detected special molecular abnormalities in patients with Lynch syndrome-related lung cancer, metastatic melanoma, anaplastic thyroid carcinoma, papillary thyroid carcinoma and liposarcoma, respectively. In these studies, scientists used molecular detection to diagnose and classify such cancers, and new, targeted therapy and immunotherapy schemes were adopted for these patients, benefiting them in the long run.

Abstract#

Title

1464

Enrichment and screening of LFS patients by analyzing TP53 germline mutations of a Chinese cancer cohort

2252

Genome profiling of thymic carcinoma identifies putative driver mutations in the NF-κB signaling pathway

2557

Germline mutation landscape in a large cohort of Chinese pancreatic cancer patients

0803

Molecular diagnosis and immunotherapy of a rare lung carcinoma patient associated with PMS2 c.1144+1G>A mutation-driven Lynch syndrome

0422

Sequential targeted therapy and immunotherapy of a BRAF positive metastatic melanoma patient with BRAF inhibitor vemurafenib, MEK inhibitor cobimetnib and a novel PD-1 antibody Sintilimab

2183

Genomic profiling of small bowel adenocarcinoma reveals targetable mutations in multiple signaling pathways

2217

More somatic mutations can be detected in cerebrospinal fluid ctDNA of NSCLC patients with brain metastases

2182

Evaluation of somatic and germline mutations in ampullary carcinoma reveals actionable targets in multiple signaling pathways

1209

An effective treatment for recurrent and inoperable anaplastic thyroid carcinoma using sintilimab and anlotinib: a case report

1681

Correlation of BRCA1/2 mutations with response to immune checkpoint inhibitors in colorectal cancer

1641

The predictive values of ARID1A mutations for response to immune checkpoint inhibitors are varied in different types of solid tumors

1639

Correlation of KMT2C/D loss-of-function mutations with PD-L1 expression and response to immune checkpoint inhibitors in solid tumors

1640

Correlations of DNA damage response gene alterations with response to immune checkpoint inhibitors are different in solid tumors

2288

Identification of gene fusions in soft tissue sarcoma improved by integrative DNA and RNA sequencing

2163

Molecular characteristics of CDK4 and/or MDM2 amplification in Chinese soft tissue sarcoma (STS) patients

0625

Co-amplification of CDK4 and MDM2 plus HMGA2 fusion in a patient with myogenic differentiation dedifferentiated liposarcoma

2223

Distinct genomic features of cutaneous, acral and mucosal melanomas in a Chinese retrospective cohort

2216

Exploration of the genomic features of pan-neuroendocrine tumors in a Chinese retrospective analysis

2215

Landscape of RET fusion identified by next‑generation sequencing in a Chinese multi-cancer retrospective analysis

1199

Mosaic KRAS G12S mutation associates with poor outcome in papillary thyroid carcinoma: A case report

2080

Tumor microsatellite instability detection method using paired tumor-normal sequence data

2313

The characteristics of ERBB2 exon 20 insertion in a large cohort of Chinese NSCLC patients

On April 13, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported planned conference presentations scheduled through April and May (Press release, Soligenix, APR 13, 2021, View Source [SID1234578028]). The presentations will focus on the HyBryte (SGX301 or synthetic hypericin) cutaneous T-cell lymphoma (CTCL) program, including elaboration on previously released efficacy and safety outcomes in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and an update on the CiVax (COVID-19 subunit vaccine) program. Registration links for each conference are included below.

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Planned Oral Presentations:

Visible Light Activated Topical Hypericin Ointment in CTCL: Phase 3 FLASH Study Results presented by Dr. Ellen Kim, Lead FLASH Investigator, at the American Academy of Dermatology Association Virtual Meeting Experience, April 23-25, 2021. As a Top 12 Late-Breaking Research Abstract, Dr. Kim will also be present at a live Q&A session on April 24 from 2-3 pm Central Time. Attendees can register here.

Progress towards a Thermostabilized, Single-Vial, COVID-19 Subunit Vaccine with a Nano-emulsion Adjuvant presented by Dr. Oreola Donini, Chief Scientific Officer, at the Annual Conference on Vaccinology Research, April 26-27, 2021. Attendees can register here.

Topical hypericin ointment photodynamic therapy is effective and safe in CTCL (FLASH study) presented by Dr. Ellen Kim, Lead FLASH Investigator, at the Society for Investigative Dermatology Virtual Meeting, May 3-8, 2021. Attendees can register here.

About HyBryte

HyBryte (SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light 16 to 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and the clinical study report to support the NDA is in the process of being finalized.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

About CiVax

CiVax is the Company’s heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. Under the Company’s Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UHM have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including hemorrhagic disease caused by Zaire ebolavirus, Sudan ebolavirus as well as Marburg marburgvirus, with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). In March 2020, Soligenix and its collaborators expanded the technology platform to assess compatibility with vaccine candidates targeting SARS-CoV-2, the cause of COVID-19.

The vaccine platform includes three essential components:

a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;
an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and
a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.
The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19. The ability to provide a thermostabilized, single vial vaccine, is particularly important in the context of rapid and broad vaccine distribution.

These same components are now being applied to coronavirus vaccine, using the well-defined surface glycoprotein, known as the Spike protein, as the antigen. Nonclinical work in mice with a prototype vaccine recently have been made available, demonstrating the ability of the CoVaccine adjuvant in combination with a prototype antigen, to:

stimulate immunity within 14 days after the first vaccination;
induce a balanced Th1 response, believed to be critical to inducing immunity without aggravating disease pathology;
induce a neutralizing antibody response; and
induce a cell mediated immune response.
CiVax development is being funded through an SBIR grant from NIAID (grant number 1 R44 AI157593-01).

On April 13, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has launched beLAB2122, a translational $ 20 million BRIDGE in collaboration with Bristol-Myers Squibb Company (NYSE: BMY) (Press release, Evotec, APR 13, 2021, View Source;announcements/p/evotec-launches-belab2122-translating-academic-innovation-from-leading-german-life-science-region-in-collaboration-with-bristol-myers-squibb-6047 [SID1234577948]). beLAB2122 brings together leading academic institutions from the Rhine-Main-Neckar region of Germany with the goal of efficiently advancing first-in-class therapeutic options across all therapeutic areas and formats into investable drug discovery and early development projects.

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LET’S CALL EVOTEC | THOMAS HANKE ON BELAB2122 AND BRIDGES

Mediated and supported by BioRN, the Life Science Cluster Rhein Neckar, beLAB2122 for the first time brings together the European Molecular Biology Laboratory ("EMBL"), the German Cancer Research Center ("DKFZ"), the Goethe University Frankfurt, Heidelberg University and the University of Tübingen in one collaboration with industry partners. Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with pharma and funders which may lead to the formation of jointly owned new companies. Since 2016, Evotec has established several BRIDGE collaborations with a variety of academic, pharma, and venture capital partners across Europe and North America.

Evotec launches beLAB2122 in cooperation with Bristol Myers Squibb, Evotec’s long-standing collaborator in drug discovery across several therapeutic areas. Together the sponsors intend to tap into Europe’s foremost academic clusters of excellence in the life sciences, both validating and advancing innovative research in therapeutics and related technologies from academia to enable the formation of new, collectively owned spin-out companies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: "We are very excited about the launch of beLAB2122, a truly transformative framework that leverages first-class science from one of Europe’s leading life science cluster regions with lots of potential to generate medical progress. We look forward to unlocking this potential by using our ‘data-driven R&D Autobahn to Cures’ to further validate and develop these approaches to translate the promising early-stage research into the medicines of the future."

Dr Thomas Hanke, Head of Academic Partnerships at Evotec, added: "We are delighted to see the first BRIDGE in Germany becoming reality and look forward to working closely with our academic partners in the Rhine-Main-Neckar area and our colleagues at Bristol Myers Squibb to identify and accelerate the next generation of first-in-class therapeutics across all modalities and therapeutic areas. We would also like to particularly thank BioRN for continuously supporting beLAB2122."

Dr Rupert Vessey, Executive Vice President and President, Research and Early Development at Bristol Myers Squibb commented: "We are excited by the opportunity to support beLAB2122 in the translation of novel scientific research from these leading German academic institutions. Given their past experience with successful BRIDGEs, we believe Evotec is well-equipped to interpret the many lines of scientific inquiry resulting from this collaboration and use its proprietary platforms to deliver quality data that may one day lead to potentially novel therapies for patients."

Prof. Matthias Hentze, EMBL Director, said: „This collaboration has been established at a time of increasing awareness that the efficient and rapid translation of research outcomes is essential. beLAB2122 is a transformative collaboration to accelerate the validation of therapeutic concepts for the benefit of society. EMBL, as Europe’s leading molecular biology research institute, is delighted to be part of this initiative along with some of the most renowned institutes in the region and beyond. With Evotec and Bristol Myers Squibb this collaboration has world-renowned industrial sponsors to help bring successful ideas into the market and to foster cutting-edge research and innovation."

Dr Rainer Wessel, Chief Innovation Officer, German Cancer Research Center (DKFZ), added: "For DKFZ, a major goal is to foster transfer of our excellent research into highly innovative applications that benefit cancer patients world wide. The beLAB2122 collaboration is a major step in gaining critical mass and speed together with other scientific and commercial leaders to achieve that goal."

Prof. Dr Manfred Schubert-Zsilavecz, Vice President of Goethe University Frankfurt responsible for the Third Mission and Professor for Medicinal Chemistry, pointed out: "Pharmaceutical and translational medical research are two of the key strengths of Goethe University Frankfurt, and numerous of our research projects aim to contribute to closing the innovation gap in drug development. We are extremely happy to be part of the beLAB2122 research network in order to boost cooperation between academic and industrial research, for the sake of suffering patients."

Prof. Dr Matthias Weidemüller, Vice-Rector Innovation and Transfer, Heidelberg University, affirmed: "Heidelberg University is excited to be part of the Evotec BRIDGE collaboration beLAB2122. It is of fundamental importance that our cutting-edge research be translated into applications on a broader scale. This collaboration brings together leading institutions in the Rhine-Main-Neckar region that conduct research at the forefront of life science. I am positive that – within the BRIDGE framework – we can generate added momentum for converting scientific achievements into future therapeutics."

Prof. Dr Peter Grathwohl, Vice-President of Research and Innovation of the University of Tübingen, joined: "The University of Tübingen is delighted to be part of beLAB2122. The transfer of research results to application is very important to us: In the future, we want to provide excellent opportunities for our researchers to contribute their expertise to concrete collaboration projects with sponsors in economy and industry."

The name beLAB2122 refers to the Rhine, Main, and Neckar rivers which connect the member institutions with one another and which total 2,122 kilometres in length. For further information on beLAB2122, please visit www.belab2122.org.

On April 13, 2021 BridgeBio Pharma, Inc. (NASDAQ: BBIO) reported a collaboration with the University of California, Davis (UC Davis), to advance research and the development of investigational medicines for patients with genetically driven conditions and cancers (Press release, BridgeBio, APR 13, 2021, View Source [SID1234577969]).

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"UC Davis is a top-tier research university and we feel honored to get the chance to collaborate closely with the talented team there as we work to discover, create, test and deliver breakthrough medicines for people who are suffering from genetic diseases," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Under the agreement, the BridgeBio team will work closely with investigators at UC Davis to seek and evaluate potential research projects in genetic disease and precision oncology.

"We have a great appreciation for BridgeBio’s vision to create new pathways that connect innovative research to potential treatments for diseases that may not otherwise be pursued in the marketplace," said Bill Tucker, interim associate vice chancellor for Innovation and Technology Commercialization at UC Davis. "We are thrilled to combine our expertise in the hope of expanding the impact of our research to help those in need."

BridgeBio collaborates with stand-out academic institutions, including UC Davis, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

With a diverse pipeline encompassing investigational therapies for rare diseases and genetically validated cancers, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing life-changing medicines for patients with genetically driven conditions as quickly and safely as possible.

On April 13, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of prospective, multi-center long-term outcomes data in cutaneous melanoma as impacted by DecisionDx-Melanoma (Press release, Castle Biosciences, APR 13, 2021, View Source [SID1234577986]). DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors.

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The article, titled "Long-term outcomes in a multicenter, prospective cohort evaluating the prognostic 31-gene expression profile for cutaneous melanoma," was published in the peer-reviewed journal, JCO Precision Oncology.

Study background:

The study’s key objective was to demonstrate the prognostic value of DecisionDx-Melanoma with long-term follow-up that extends the assessment time period for a previously studied cohort. The study achieved its primary objective and expanded upon prior results to show the ability of the test to accurately identifying recurrence risk of patients with American Joint Committee on Cancer (AJCC) 8th Edition staging system early stage I-IIA disease.

Study results:

Consistent with previous prospective validation and performance studies, the DecisionDx-Melanoma test was significantly associated with the outcomes of recurrence-free (RFS), distant metastasis-free (DMFS) and overall survival (OS) in univariate analysis of patients diagnosed with stage I-III melanoma. The test’s result was also a significant, independent predictor of the same endpoints when compared to AJCC staging in multivariable analysis. Additionally, study authors conclude that combining DecisionDx-Melanoma test results with AJCC staging enhances sensitivity and negative predictive value over each approach alone, identifying those who may benefit from more or less intense follow-up. Further, accurate risk stratification by the DecisionDx-Melanoma test was demonstrated in the cohort of patients with stage I-IIA melanoma, a group that is currently recommended to receive low-intensity management but that contributes substantially to the number of patients who die from melanoma each year.

"The most impactful measures of appropriate melanoma management include survival time and the quality of that time post-diagnosis," said first author Eddy Hsueh, M.D., surgical oncologist at St. Louis University, St. Louis, MO. "In this study, we demonstrated that DecisionDx-Melanoma results are significant predictors of real-world recurrence and metastasis rates, which suggests that the test can provide clinically actionable information when making cancer management decisions in early-stage melanoma."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.