On June 22, 2022 Novartis reported the US Food and Drug Administration (FDA) granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options1,2 (Press release, Novartis, JUN 22, 2022, View Source;mekinist-receives-fda-approval-for-first-tumor-agnostic-indication-for-braf-v600e-solid-tumors-301573580.html [SID1234616193]). In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Tafinlar + Mekinist is the first and only BRAF/MEK inhibitor to be approved with a tumor-agnostic indication for solid tumors carrying the BRAF V600E mutation, which drives tumor growth in more than 20 different tumor types, and it is the only BRAF/MEK inhibitor approved for use in pediatric patients1,2.

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"The combination of dabrafenib and trametinib demonstrated meaningful efficacy in multiple BRAF-positive tumor types, including in some patients with rare cancers who have no other treatment options available," said principal investigator Dr. Vivek Subbiah, M.D., associate professor of Investigational Cancer Therapeutics and center medical director of the Clinical Center for Targeted Therapy, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston, Texas. "Physicians should consider a BRAF test as a routine diagnostic step that could enable a new option for treating patients with many solid tumors."

The FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials. In the Phase II ROAR (Rare Oncology Agnostic Research) basket study and the NCI-MATCH Subprotocol H study, Tafinlar + Mekinist resulted in overall response rates of up to 80% in patients with BRAF V600E solid tumors, including high- and low-grade glioma, biliary tract cancer and certain gynecological and gastrointestinal cancers. An additional study (Study X2101) demonstrated the clinical benefit and acceptable safety profile of Tafinlar + Mekinist in pediatric patients1,2.

"Tackling cancer is complex, which is why it is so important that we continue to follow the science as we pursue meaningful advances and new approaches to treating cancer," said Reshema Kemps-Polanco, Head, Novartis Oncology US. "We are grateful to the patients, and to the multitude of individuals and teams working together to make this latest approval possible as we strive to do more for more people living with cancer."

The safety profile of Tafinlar + Mekinist observed in these studies was consistent with the known safety profile in other approved indications.

BRAF mutations have been identified as drivers of cancer growth across a wide range of solid tumors, including in rare cancer types that can be challenging to study in Phase III trials and often have limited treatment options3,4. BRAF V600E is the most common type of BRAF mutation, accounting for up to 90% of BRAF-mutant cancers3.

Full prescribing information for Tafinlar + Mekinist can be found at
View Source and
View Source

About Tafinlar + Mekinist
The combination of Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition research and patients reached, may help to slow tumor growth by blocking signals associated with the BRAF and MEK kinases that are implicated in the growth of various types of cancer1-5. Tafinlar + Mekinist has been studied in more than 6,000 BRAF-positive patients in more than 20 ongoing and completed trials, including in pediatric patients 1 year of age and older, and has been prescribed to more than 200,000 patients worldwide5.

Tafinlar + Mekinist is also approved for use in BRAF-positive unresectable or metastatic melanoma, as an adjuvant treatment for BRAF-positive melanoma after surgery, in BRAF-positive metastatic non-small cell lung cancer, and in BRAF-positive anaplastic thyroid cancer1,2. Tafinlar + Mekinist is not indicated for treatment of patients with colorectal cancer or for treatment of patients with wild-type BRAF solid tumors.

Indication and Important Safety Information

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:

that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
that has a certain type of abnormal "BRAF" (V600E or V600K mutation-positive) gene
TAFINLAR and MEKINIST are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal "BRAF" gene from coming back after the cancer has been removed by surgery.

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal "BRAF V600E" gene.

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC):

that has spread to other parts of the body and you have no satisfactory treatment options and
that has a certain type of abnormal "BRAF" gene
TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat solid tumors in adults and children 6 years of age and older:

that cannot be removed by surgery or have spread to other parts of the body, and that have gotten worse (progressed) and you have no satisfactory treatment options and
that have a certain type of abnormal "BRAF" gene
The effectiveness of TAFINLAR and MEKINIST in these patients is based on 2 adult studies and 1 pediatric study that measured 2 types of response to treatment (response rate and duration of response). No clinical information is available to show if these patients treated with TAFINLAR and MEKINIST live longer or if their symptoms improve. Ongoing studies exist to determine how TAFINLAR and MEKINIST works over a longer period.

TAFINLAR, in combination with MEKINIST, is not for use in treating people with colorectal cancer or wild-type BRAF solid tumors. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.

Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you.

It is not known if TAFINLAR used in combination with MEKINIST is safe and effective in children younger than 6 years of age.

TAFINLAR and MEKINIST, in combination, may cause serious side effects such as the risk of new cancers, including both skin cancer and nonskin cancer. Patients should be advised to contact their health care provider immediately for any skin changes, including a new wart, skin sore, or bump that bleeds or does not heal, or a change in the size or color of a mole.

When TAFINLAR is used in combination with MEKINIST, it can cause serious bleeding problems, especially in the brain or stomach, that can lead to death. Patients should be advised to call their health care provider and get medical help right away if they have any signs of bleeding, including headaches, dizziness, or feeling weak, coughing up blood or blood clots, vomiting blood or their vomit looks like "coffee grounds," or red or black stools that look like tar.

MEKINIST, alone or in combination with TAFINLAR, can cause inflammation of the intestines or tears in the stomach or intestines that can lead to death. Patients should report to their health care provider right away if they have any of the following symptoms: bleeding, diarrhea (loose stools) or more bowel movements than usual, stomach-area (abdomen) pain or tenderness, fever, or nausea.

TAFINLAR, in combination with MEKINIST, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

The combination of TAFINLAR and MEKINIST can cause heart problems, including heart failure. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their health care provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

TAFINLAR, in combination with MEKINIST, can cause severe eye problems that can lead to blindness. Patients should be advised to call their health care provider right away if they get: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

TAFINLAR, in combination with MEKINIST, can cause lung or breathing problems. Patients should be advised to tell their health care provider if they have new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Fever is common during treatment with TAFINLAR in combination with MEKINIST but may also be serious. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their health care provider right away if they get a fever.

Rash and other skin reactions are common side effects of TAFINLAR in combination with MEKINIST. In some cases, these rashes and other skin reactions can be severe or serious, may need to be treated in a hospital, or lead to death. Patients should be advised to call their health care provider if they get any of the following symptoms: blisters or peeling of skin, mouth sores, blisters on the lips or around the mouth or eyes, high fever or flu-like symptoms, and/or enlarged lymph nodes.

Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR in combination with MEKINIST. For patients who are diabetic, their health care provider should check their blood sugar levels closely during treatment. Their diabetes medicine may need to be changed. Patients should be advised to tell their health care provider if they have increased thirst, urinate more often than normal, or produce an increased amount of urine.

TAFINLAR may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Patients should be advised to tell their health care provider if they have yellow skin (jaundice), weakness or dizziness, or shortness of breath.

TAFINLAR, in combination with MEKINIST, can cause new or worsening high blood pressure (hypertension). A patient’s blood pressure should be checked during treatment. Patients should be advised to tell their health care provider if they develop high blood pressure, their blood pressure worsens, or if they have severe headache, lightheadedness, blurry vision, or dizziness.

For women of reproductive potential, TAFINLAR and MEKINIST, in combination, can harm your unborn baby. Your health care provider will do a test to see if you are pregnant before starting treatment with TAFINLAR and MEKINIST in combination. Use effective birth control (contraception) during treatment with TAFINLAR and MEKINIST in combination, and for 4 months after stopping treatment with TAFINLAR and MEKINIST.

Men (including those who have had a vasectomy) should use condoms during sexual intercourse during treatment with TAFINLAR and MEKINIST and for at least 4 months after the last dose of TAFINLAR and MEKINIST.

The most common side effects for patients with metastatic melanoma receiving the combination are pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema, and cough. The most common side effects for patients with stage III melanoma as adjuvant therapy receiving the combination are pyrexia, tiredness, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. The most common side effects for patients with NSCLC receiving the combination are pyrexia, tiredness, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea. The most common side effects for adults with solid tumors that cannot be removed by surgery or have spread to other parts of the body who are receiving the combination are fever, tiredness, nausea, rash, chills, headache, bleeding, cough, vomiting, constipation, diarrhea, muscle and or joint aches, and swelling of arms and legs. The most common side effects for children with solid tumors that cannot be removed by surgery or have spread to other parts of the body who are receiving the combination are fever, rash, vomiting, tiredness, dry skin, cough, diarrhea, acne, headache, stomach-area (abdomen) pain, nausea, bleeding, constipation, and skin infection around fingernails or toenails.

On June 22, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that the company has expanded the European Union (EU) label indication of its Bladder EpiCheck test (Press release, Nucleix, JUN 22, 2022, View Source [SID1234616192]). Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer.

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The technology was initially indicated for use as a non-invasive method for the monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures.

Bladder cancer is the fifth most common cancer in Europe with more than 200,000 new cases of the disease diagnosed annually.1 With bladder cancer, patients typically experience symptoms of traces of blood in the urine, called hematuria, though this is not usually visible to the naked eye.2 Up to 30% of adults will experience hematuria at some point in their life, so it is crucial to quickly and non-invasively determine if the symptom is associated with bladder cancer, to ensure a urological workup is conducted immediately.2 Bladder EpiCheck demonstrated 88% sensitivity in detecting the primary high-risk bladder cancer, with a specificity of 98% or more.

"The current workup of hematuria is invasive, costly and usually performed too late, due to delayed referrals to urologists, all the while symptoms can worsen and diagnosis of the disease is delayed when treatment is critical," said Eli Frydman, Ph.D. MBA, President EMEA of Nucleix. "With this expanded label indication and high specificity of Bladder EpiCheck in this population, we’re able to offer a cost-effective, non-invasive approach to triage hematuria patients and help identify bladder cancer early."

Two recently published studies evaluated the performance of Bladder EpiCheck in the detection of primary and recurrent UTUC including 220 patients.3,4 Bladder Epicheck showed high-grade sensitivity of 96-98% and specificity of 81-100% in urine collected from the ureter. One of the studies also reported high-grade sensitivity of 71% and specificity of 81% in bladder urine. In both studies, test sensitivity was higher than cytology.

"Identifying patients with high-grade UTUC early is critical – if missed, the disease can progress to metastases very quickly and the standard treatment, which is the removal of ureter and kidney, can lead to considerable morbidity," said Aharona Shuali, M.D., Vice President of Medical Affairs at Nucleix. "We are encouraged by this expanded label indication because of its potential impact on patients. Bladder EpiCheck delivers highly accurate results in a non-invasive way and could play an important role in the diagnosis and follow-up of this disease, particularly in ruling-out high-grade disease."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect primary and recurrent bladder and upper urinary tract cancers. The test analyzes subtle disease-specific changes in DNA methylation markers, with sensitivity of 91-96% of high-grade cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-grade cancer is present.5 Overall specificity of Bladder EpiCheck is 84%, 81% and 98% for recurrent bladder cancer, UTUC and primary cancers, respectively, ensuring a low rate of false positive results. Bladder EpiCheck is intended for use as a non-invasive method for detection of urinary tract cancers in conjunction with standard methods. Bladder EpiCheck is CE-marked and commercially available in Europe. The test is not available for sale in the United States.

On June 22, 2022 Ikonisys SA (Code ISIN: FR00140048X2 / Mnémonique: ALIKO) (Paris:ALIKO), a company specializing in the early and accurate detection of cancer with a unique fully-automated solution for medical diagnostic labs, reported the first sale of an Ikoniscope20 digital fluorescence microscope solution together with its optimized reagents (Press release, Ikonisys, JUN 22, 2022, View Source [SID1234616190]).

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As announced during the IPO of Ikonisys, the primary initial focus of the commercialization strategy for the United States is to convert current customers into Ikoniscope20 users. An active user of Ikonisys’ former Ikoniscope Gen1 platform up to today, Comprehensive Urology has decided to upgrade its system to the Ikoniscope20 and at the same time to utilize the optimized reagents provided by Ikonisys to perform its bladder cancer molecular diagnosis.

Ikonisys’ business model is to sell a fully integrated solution comprising hardware, software and consumables. Reagents, needed to perform each single test, are an essential part of the molecular diagnostics market. Ikonisys is offering clients optimized reagents at a competitive rate, ensuring greater performance with the ikoniscope20.

The Ikoniscope20 combined with Ikonisys’ FISH probes will automate early bladder cancer diagnosis, allowing Comprehensive Urology to perform several thousand tests per year.

On June 22, 2022 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0031, a next generation selective RET inhibitor (SRI) (Press release, Ellipses Pharma, JUN 22, 2022, View Source [SID1234616189]).

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Developed in partnership with Sichuan Kelun-Biotech Pharmaceutical Co., Ltd (Kelun-Biotech), EP0031 (known as A400 when in conjunction with Kelun-Biotech’s ongoing regional development) is a next generation SRI under development for the treatment of RET-altered cancers, with the first trials to focus on thyroid and non-small cell lung cancer. Kelun-Biotech has already commenced a clinical trial of EP0031 (A400) in China, which is progressing rapidly towards the dose expansion stage.

Approval of the IND is a significant step in the initiation of a global, modular Phase 1/2 trial to evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered cancers including patients who have not received prior treatment with first generation SRIs. The trial will include sites across the US and Europe and the first patient is anticipated to enter the dose escalation part of the trial in Q3 2022. Further regulatory submissions in the UK and EU are anticipated shortly to support the initiation of the trial in countries outside of the US.

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:
"EP0031 offers the potential for a promising new treatment option that seeks to address some of the issues with first generation SRIs. Next generation SRIs offer the potential to expand the armamentarium against RET-driven cancers and further improve patient outcomes. This IND marks another important step for Ellipses. Our strategy is to advance the most promising cancer treatments to the clinic as soon as possible, and the clearance of this IND will allow us to rapidly move forward with our planned clinical trial of EP0031."

ENDS

About EP0031 (A400)
EP0031 is a potent next generation SRI with broad activity against common RET fusions and mutations, including solvent front resistance mutations. Therefore, EP0031 (A400) may overcome resistance mechanisms to first generation SRIs. In preclinical studies, EP0031 (A400) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. EP0031 (A400) also demonstrated good penetration of the blood brain barrier in animal models. An IND application for EP0031 (A400) was approved by China’s National Medicinal Products Administration (NMPA) in June 2021 and a Phase 1/2 trial is ongoing in China. In March 2021, Kelun-Biotech granted Ellipses an exclusive license for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and part of the Asia-Pacific region.

On June 22, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data demonstrating the clinical value of the Company’s tests for skin cancer in guiding more informed disease management decisions (Press release, Castle Biosciences, JUN 22, 2022, View Source [SID1234616188]). Data on each of Castle’s skin cancer tests, as outlined below, was shared during the recent Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2022 .

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DecisionDx-Melanoma

While patients with thin cutaneous melanoma (CM) tumors (T1, ≤1mm) are typically deemed low risk by traditional staging alone, studies have shown that up to 15%1-3 of these patients will go on to experience disease recurrence. As such, there is an opportunity to use DecisionDx-Melanoma to identify which patients with thin CM tumors may have aggressive tumor biology and thus could benefit from increased surveillance through advanced imaging or adjuvant therapy.

"The data in this study reinforced what we find in clinical practice: some patients initially thought to be low risk by traditional, clinicopathologic staging methods can have more aggressive tumor biology, and their melanoma may come back, even after their primary tumor has been removed," said lead study author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates in Portsmouth, New Hampshire. "DecisionDx-Melanoma can help identify these high-risk patients who may warrant a need for more intense treatment and surveillance to reduce their likelihood of recurrence and potentially improve the overall outcome of their disease."

Patients with T1 CM (classified according to the American Joint Committee on Cancer Eighth Edition (AJCC8) staging framework) from three previously published studies were combined for analysis (N=979). The results of the analysis was shared in a poster titled, "The 31-gene expression profile test stratifies the risk of recurrence in patients with T1 cutaneous melanoma: Results of a pooled analysis of 979 patients." The poster, which is available here, highlights the ability of DecisionDx-Melanoma to stratify patients with thin CM tumors according to their risk of recurrence.

Study highlights:

In the study, patients with thin tumors who received a DecisionDx-Melanoma high-risk Class 2B result had lower 3-year recurrence-free survival than patients with a low-risk Class 1A result (75.9% vs. 97.7%) and an 8-fold higher recurrence rate (22.5% vs. 2.7%, p<0.001).
Moreover, nearly one in four patients in the cohort who received a DecisionDx-Melanoma high-risk Class 2B result experienced melanoma recurrence, with a median 11-month time to recurrence.
A high-risk Class 2B test result was a significant predictor of disease recurrence (HR=4.49, p=0.001), similar to a positive sentinel lymph node (SLN) (HR=4.46, p<0.001). As a positive SLN is evidence that a patient’s melanoma has spread, these patients are candidates for advanced imaging and potentially, adjuvant therapies. These data suggest that patients receiving a DecisionDx-Melanoma Class 2B result could benefit from similar, more intense treatment aligned to their elevated risk of recurrence.
DecisionDx-SCC

The rise of squamous cell carcinoma (SCC) diagnoses is an emerging problem in the U.S. that is complicated by broad clinicopathological staging criteria and treatment guidelines for the disease. Castle’s DecisionDx-SCC test was designed to address this unmet medical need for patients with SCC and one or more high-risk factors. The test provides clinically actionable information about a patient’s biologic risk of metastasis, independent of clinicopathologic factors and traditional staging systems, which can help guide more informed and risk-appropriate treatment decisions within established guidelines.

The poster, titled "Study of 400 dermatologic clinicians corroborates the clinical impact of the prognostic 40-gene expression profile (40-GEP) test in patients with high-risk cutaneous squamous cell carcinoma (SCC)," shares the impact of DecisionDx-SCC test results on clinicians’ management of invasive SCC. The poster is available here.

"The study showed that many clinicians would consider de-escalating treatment plan decisions and potentially forgoing interventions for some patients if their DecisionDx-SCC test results indicated a low biological risk of metastasis," said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. "DecisionDx-SCC test results, when considered on their own and in the context of other clinicopathologic staging systems, can lead to risk-aligned treatment plan changes, either de-intensified or intensified, based on a patient’s individual metastatic risk. We were pleased that the survey responses supported this."

Study highlights:

The majority of clinicians (approximately 80%) indicated they would recommend ordering DecisionDx-SCC for patients with SCC lesions on high-risk locations when also considering the size of the lesion.
Previous studies4,5 have found that DecisionDx-SCC test results (low, moderate or high biological risk results) led to risk-aligned decreases or increases in clinician-directed treatment plans.
The survey results supported this, with the majority of clinicians who recommend the use of interventions for patients with high-risk SCC indicating they would consider forgoing certain treatments (64% for radiologic nodal imaging, 68% for SLN biopsy and 66% for adjuvant radiation therapy) for at least some patients who received a DecisionDx-SCC Class 1 test result (low biologic risk of metastasis).
Intention to further reduce recommendations for radiologic nodal imaging or SLN biopsy with a Class 1 test result was seen in those clinicians who were already using DecisionDx-SCC in their clinical practice (72% and 75%, respectively), accentuating the impact of the test among users.
MyPath Melanoma and DecisionDx DiffDx-Melanoma

MyPath Melanoma and DecisionDx DiffDx-Melanoma are Castle’s diagnostic tests designed to provide objective, highly accurate results to aid in the diagnosis of suspicious melanocytic lesions with ambiguous histopathology. The tests can provide clinically actionable information to help guide and potentially increase confidence in a diagnosis, if any uncertainty or discordance exists, to help clinicians deliver more informed patient management plans and provide their patients with more appropriate and individualized care.

The poster, titled "The current 23- and 35-gene expression profile (GEP) ancillary diagnostic testing workflow for difficult-to-diagnose melanocytic lesions increases the rate of actionable results to 99%," highlights how the current laboratory workflow for Castle’s two diagnostic tests can leverage the strengths of both individual tests to report accurate and clinically actionable results. The poster can be viewed here.

Study highlights:

In the current laboratory workflow, clinical samples are processed first through MyPath Melanoma, and if a technical failure or intermediate result is received, processed next through DecisionDx DiffDx-Melanoma.
In the study, the test workflow demonstrated a high rate of accuracy in the performance cohort, with 96.0% sensitivity and 87.8% specificity.
Based on the analysis of Castle test results reported over a six-month period (June 3-Dec. 3, 2021), the current workflow substantially improved the reporting of clinically actionable results from a historic rate of ~77% with MyPath Melanoma alone to over 99% when both tests were run in a combined workflow.
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 (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. 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. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About MyPath Melanoma and DecisionDx DiffDx-Melanoma

MyPath Melanoma and DecisionDx DiffDx-Melanoma are two gene expression profile tests designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.