On July 11, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a study that establishes an evidence-based population to guide appropriate use of the DecisionDx-Melanoma test in patients with thinner tumors (Press release, Castle Biosciences, JUL 11, 2019, View Source [SID1234537475]). The study was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine.

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Current best practice for the use of DecisionDx-Melanoma includes informing two key treatment plan decisions following a melanoma diagnosis. First, for most patients with cutaneous melanoma who are eligible for a sentinel lymph node biopsy (SLNB), DecisionDx-Melanoma can identify patients at low risk of positivity and inform the decision to undergo this surgical procedure. This can include patients with tumor thickness less than or equal to 2.0 mm with no minimum thickness criteria.

The second use for DecisionDx-Melanoma is designed to predict an individual’s risk of recurrence to help physicians determine an appropriate level of follow-up, imaging and referrals. Previously published validation studies have reported that the test can accurately determine risk of recurrence in patients with Stage I-III melanoma, including tumors with a thickness less than 1.0 mm. The purpose of this study was to determine whether an evidence-based thickness threshold can be established for this second use to further guide appropriate clinical use of the test in patients with thinner (1.0 mm or less) melanoma tumors.

Key Study Findings:

An analysis of a large, multicenter dataset (n=1,479) that calculated event rates by tumor thickness and DecisionDx-Melanoma class result found a separation of recurrence rates between Class 1A (lowest risk) and Class 2B (highest risk) at a threshold of 0.3 mm.
In a separate analysis of tumors ≤1.0 mm thick tested clinically (n=8,944) and at a large dermatopathology practice (n=437), tumors with a thickness between 0.3 mm and 1.0 mm showed a 10.8% and 15.7% non-Class 1A result, respectively, suggesting that there is a benefit of risk assessment for this portion of the thin tumor population.
In two multicenter studies (n=403) that included 160 patients with tumors ≤1.0 mm, most patient management changes made following DecisionDx-Melanoma testing were recommended for those with a tumor thickness ≥0.3 mm.
These results suggest a minimum Breslow thickness of 0.3 mm as an appropriate population to use DecisionDx-Melanoma to guide decisions on follow-up for cutaneous melanoma patients. Based on a previously published validation study, the test can also be used to inform decisions on SLNB in most eligible patients with tumor thickness less than or equal to 2.0 mm (no minimum tumor thickness).

"Accurate risk assessment is especially important in patients with thinner melanomas because a substantial proportion of melanoma-specific deaths occur in patients initially diagnosed with thin melanomas," commented study co-author Clay J. Cockerell, M.D., Cockerell Dermatopathology, Dallas, Texas. "These results establish an evidence-based population of patients with thin tumors who are appropriate for DecisionDx-Melanoma testing to inform follow-up decisions in the context of current melanoma management strategies."

The full published study results can be accessed at the journal’s website.

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 3,100 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 five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. 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.

More information about the test and disease can be found at www.SkinMelanoma.com.

On July 11, 2019 Gilead Sciences, Inc. (NASDAQ: GILD) reported that Christi L. Shaw will join the company as Chief Executive Officer of Kite, a Gilead Company, and will become a member of Gilead’s senior leadership team (Press release, Gilead Sciences, JUL 11, 2019, View Source [SID1234537491]).

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Ms. Shaw is a renowned leader with deep experience providing commercial, financial, strategic, medical and operations leadership across the biopharmaceutical industry. Ms. Shaw currently serves as Senior Vice President of Eli Lilly &. Co., and President of Lilly Bio-Medicines. She also serves as a board member of both Avantor, Inc. and the Biotechnology Industry Organization (BIO), and as an advisor to the Healthcare Businesswomen’s Association.

Prior to joining Lilly, Ms. Shaw most recently served as U.S. Country Head and President of Novartis Corp. and North American Head of Novartis Oncology. She earned a BA in Business Administration from Iowa State University and an MBA from the University of Wisconsin.

"We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy," said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. "Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world."

"Kite’s vision of transformational drug development – and of curing cancer – is one that I am extremely passionate about," said Ms. Shaw. "I look forward to working with the many talented individuals in this organization, as we change the way cancer is treated and bring forward important, life-saving therapies."

On July 11, 2019 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported that it will release the financial results for its second quarter ended June 30, 2019 on Thursday, August 1, 2019 after the market closes (Press release, Select Medical, JUL 11, 2019, View Source [SID1234537511]).

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Select Medical will host a conference call regarding its second quarter results, as well as its business outlook, on Friday, August 2, 2019, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 5489707. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, August 9, 2019. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 5489707. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Select Medical is one of the largest operators of critical illness recovery hospitals (previously referred to as long term acute care hospitals), rehabilitation hospitals (previously referred to as inpatient rehabilitation facilities), outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Our reportable segments include the critical illness recovery hospital segment, rehabilitation hospital segment, outpatient rehabilitation segment, and Concentra segment. As of March 31, 2019, Select Medical operated 97 critical illness recovery hospitals in 28 states, 27 rehabilitation hospitals in 11 states, and 1,684 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 525 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At March 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Investor inquiries:

Joel T. Veit
Senior Vice President and Treasurer
717-972-1100
[email protected]

SOURCE Select Medical Holdings Corporation

On July 11, 2019 EORTC biostatisticians reported that it will present a number of abstracts at the 40th Annual Conference of the International Society for Clinical Biostatistics (ISCB 40) which will take place from 14 to 18 July 2019 in Leuven, Belgium (Press release, EORTC, JUL 11, 2019, View Source [SID1234537476]).

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Oral presentations
Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials: a SISAQOL initiative update

Lien Dorme and the SISAQOL team

Date: 15 July 2019 – 4:42-5:00PM

Location: Auditory BMW 6

There are no standards on how to analyse Patient Related Outcomes (PRO) data in cancer randomised clinical trials (RCTs). The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has identified critical issues in PRO analyses in cancer RCTs and has developed standardized research objectives and analysis methods to address these issues. The analysis is presented here.

Prediction models for liver transplantation – comparisons between Cox models and machine learning techniques

George Kantidakis for his Master’s thesis work with the team of Marta Fiocco

Date: 16 July 2019 – 11:54AM-12:12PM

Location: Auditory BMW 5

Currently, Machine Learning (ML) is being discussed extensively. Questions on whether it has greater potential than Cox models when it comes to complex data have been posed. Criticism to ML is related to unsuitable performance measures and lack of interpretability, which is important for the clinicians to take decisions. In this presentation, ML techniques such as random forests and neural networks are applied to large data of 62294 patients and more than 600 variables from the United States. 106 prognostic factors are selected – 52 regarding donor and 54 regarding recipient characteristics – to predict survival of patients since liver transplantation.

A new measure to report the treatment effect in clinical trials involving competing risks

Eva Cantagallo and the BENEFIT team

Date: 17 July 2019 – 3:48-4:06PM

Location: Auditory BMW 6

Generalized pairwise comparisons (GPC) is a recent approach to describe the treatment effect in two-group clinical trials, using the net benefit as a measure of overall treatment effect. This method allows the use of a threshold of clinically relevant difference between the two groups and the simultaneous analysis of prioritized outcomes. In this presentation, the BENEFIT team expand GPC methods to a competing risks setting and provide a new measure of the treatment effect, while offering the advantages of classical GPC.

Poster
Validation of imaging biomarkers for treatment response in multicenter cancer trials conducted by EORTC

Bart Jacobs and the EORTC Imaging Group statisticians
Date: 16 July 2019 – 12:30-13:30PM

Location: Entrance Hall O&N1 + O&N2

Within QuIC-ConCePT, an EU funded initiative to qualify and validate imaging biomarkers for cancer response, two concurrent multi-centre clinical trials were performed. EORTC 1217 (NCT02273271) studied SUV measured with 3’-deoxy-3’-[18F]fluorothymidine-PET and ADC measured with diffusion weighted imaging-MRI in patients with early stage non-small cell lung cancer. EORTC 1423 (NCT02355353) focused on ADC in colorectal cancer patients with resectable liver metastases. Both trials hypothesized that early changes in these biomarkers (14 days post start of neo-adjuvant chemotherapy) could be predictive for pathological response at time of surgery. This potential relation could fasten decisions in early endpoints and would provide a cost-effective tool for early phase clinical trials benefiting both patients and investigators.

On July 11, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, reported that it will host a conference call to discuss its second quarter 2019 financial results on Tuesday, August 6, 2019 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, JUL 11, 2019, View Source [SID1234537492]). The Company also expects to issue an earnings news release on Tuesday, August 6, 2019 after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 230-1092 in the U.S. or (612) 288-0329 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 7:30 p.m. Eastern Time on August 6, 2019, and can be accessed until 11:59 p.m. Eastern Time on August 20, 2019 by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 469775.