On March 25, 2019 Castle Biosciences, Inc., a cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported that it will present five-year outcomes from a prospective, multicenter study showing that DecisionDx-UM accurately predicts metastatic risk for patients with uveal melanoma and is used by physicians to make patient management decisions based on risk categories determined by the test (Press release, Castle Biosciences, MAR 25, 2019, View Source [SID1234534606]). The study will be presented at the International Society of Ocular Oncology (ISOO) Biennial Conference held March 22-26 in Los Angeles CA.

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The CLEAR study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to track clinical management and metastatic outcomes of patients with uveal melanoma who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up.

"An accurate understanding of metastatic risk is critical to guiding surveillance planning for patients with uveal melanoma since clinicopathologic staging alone is insufficient," commented investigator Thomas M. Aaberg, Jr., M.D., Assistant Clinical Professor at Michigan State University Medical School and ocular oncologist with Retina Specialists of Michigan, who presented the study. "The results from the CLEAR study are consistent with previous publications and confirm the accuracy and clinical utility of the DecisionDx-UM test in clinical practice."

Study Highlights:

89 patients from four centers were enrolled between March 2011 and January 2017. Median follow-up time for patients without metastasis was 4.7 years.
49 patients (55%) had a low-risk Class 1 test result; 40 patients (45%) had a high-risk Class 2 test result.
All patients with Class 2 test results were managed with high intensity surveillance (imaging and/or liver function tests every 3-6 months), while 80% of Class 1 patients were managed with low intensity surveillance (imaging and/or liver function tests at a maximum of once each year) (p<0.0001).
Overall, three (6%) Class 1 patients and 22 (55%) Class 2 patients developed metastasis (p<0.0001). Median time to metastasis was 3.2 years for Class 1 and 2.5 years for Class 2.
Five-year metastasis-free survival rates were 92% for Class 1 and 42% for Class 2 (p<0.0001).
In multivariate analysis including age, ciliary body involvement, largest basal diameter and tumor thickness, the DecisionDx-UM Class 2 result was the only statistically significant predictor of metastasis (p<0.0001).
These findings are consistent with results from previously published prospective studies documenting the accuracy of DecisionDx-UM and impact on patient management.
About DecisionDx-UM

DecisionDx-UM is a GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included GEP testing for the identification of Class 1 and 2 as a prognostic factor recommended for clinical care. In 2018, the National Comprehensive Cancer Network (NCCN) published guidelines on uveal melanoma that include the DecisionDx-UM test results of Class 1A, Class 1B and Class 2B as prognostic factors to guide clinical care. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies. In addition, the DecisionDx-UM test result has been shown to be a superior predictor of metastasis compared to chromosome 3 status, mutational status, AJCC stage, and cell type, as demonstrated in multiple studies.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On March 25, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that it will report financial results for its 2018 fourth quarter on Thursday, March 28, 2019, after market close (Press release, NantHealth, MAR 25, 2019, View Source;p=RssLanding&cat=news&id=2392237 [SID1234534589]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

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The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 1059708. The call will be broadcast via the Internet at www.nanthealth.com.

On March 25, 2019 Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II Variant Application to the European Medicines Agency (EMA) for DARZALEX ▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of newly diagnosed patients with multiple myeloma who are not eligible for autologous stem cell transplantation (GATS) (Press release, Johnson & Johnson, MAR 25, 2019, View Source [SID1234534607]).

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"Today’s submission brings us a little closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma," said José Antonio Burón Vidal, vice president of medical affairs, Europe, Middle East and Africa (EMEA) region, Janssen-Cilag Limited. "We are extremely grateful to the patients and researchers who have participated in the MAIA clinical trial program and look forward to working closely with regulatory authorities to gain approval for this new association."

The application is supported by data from the MAIA Phase 3 Study (MMY3008), which was presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). 1 The study showed that at a median follow-up of 28 months, daratumumab-Rd significantly reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who were not not eligible for transplant compared to treatment with Rd alone (risk ratio [HR] = 0.56, 95% confidence interval [CI]: 0.43-0.73, p <0.0001). 1Median progression-free survival with daratumumab-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. 1 The addition of daratumumab resulted in more pronounced responses compared to Rd alone, including increased rates of complete response (CR) or better (48% vs. 25%) and very good partial response (VGPR) or better ( 79% vs. 53%). 1As part of the study, patient health, functional capacity, symptoms, psychosocial well-being and life satisfaction were assessed through measures to assess changes in quality of life related to health using the questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) on the quality of life and the study EQ-5D-5L on the health profile of EuroQol. 2

The most common adverse events during treatment grade 3/4 for daratumumab-Rd (≥10 percent) included neutropenia (50%), lymphopenia (15%), pneumonia (14%), and anemia (12%). 1 Infusion-related reactions occurred in 41% of patients receiving daratumumab-Rd, of whom 3% were grade 3/4. 1 The incidence of the second primary invasive malignancy was 3% in the daratumumab-Rd group compared to 4% in the Rd group alone. 1 EISTs leading to death were 7% in the daratumumab-Rd group, compared to 6% in the Rd group. 1The safety profile of daratumumab was consistent with previous studies. 1,3,4,5,6,7

Daratumumab-Rd is being reviewed by the US Food and Drug Administration (FDA) as part of the Real-Time Oncology Review (RTOR) pilot program.

In Europe, daratumumab is indicated: 8

in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation
as monotherapy for the treatment of adult patients with recurrent and refractory multiple myeloma whose previous treatment included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated progression of the disease during the last treatment
in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
#END#

About the MAIA 2 study
The randomized, open-label, multi-center Phase 3 study included 737 newly diagnosed patients with multiple myeloma eligible for high-dose chemotherapy and GATS, aged 45 to 90 years (median age 73). Patients were randomized to receive the combination of daratumumab-Rd or Rd alone in 28-day cycles. In the patients treated with daratumumab-Rd combination, patients received weekly 16 milligrams of daratumumab per kilogram (mg / kg) intravenously during cycles 1 and 2, every other week during cycles 3 to 6, and every 4 weeks from cycle 7. Patients in the daratumumab-Rd and Rd alone arm received lenalidomide 25 mg on days 1 to 21 of each 28-day cycle, and a weekly dose of 40 mg dexamethasone in each cycle. Patients from both treatment arms continued until disease progression or an unacceptable degree of toxicity.

About Daratumumab
Daratumumab is a novel genus that targets the CD38 gene, a surface protein that is highly expressed in multiple myeloma cells, regardless of the stage of the disease. 9,10 Daratumumab is thought to induce rapid tumor cell death through numerous immune-mediated mechanisms of action, including complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis, as well as apoptosis in the course of time. which a series of cell steps inside the cell result in the death of the cell. 11A subset of suppressor cells derived from myeloid cells (CD38 + MDSCs), CD38 + regulatory T cells, and CD38 + B cells decreased with daratumumab treatment. 11 Daratumumab is being evaluated in a comprehensive clinical development program across a range of multiple myeloma therapies, including first-line and post-relapse therapies. 2,12,13,14,15,16,17,18 Ongoing or planned studies are being conducted to evaluate its potential in the treatment of other hematologic malignant and pre-malignant diseases in which CD38 is expressed, such as indolent myeloma . 19,20 For more information, please consultwww.clinicaltrials.gov .

For more information about daratumumab, please see the Summary of Product Characteristics at View Source .

In August 2012 , Janssen Biotech, Inc. and Genmab A / S entered into a worldwide agreement that granted Janssen an exclusive license to develop, manufacture and market daratumumab. 21

About Multiple Myeloma Multiple
myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterized by excessive proliferation of plasma cells. 22 More than 48,200 people have been diagnosed with multiple myeloma in Europe in 2018, and more than 30,800 patients have died. 23 Nearly half of newly diagnosed patients do not achieve five-year survival, 24 and nearly 29% of multiple myeloma patients die within one year of diagnosis. 25

Although the treatment may lead to a remission, unfortunately, patients will most likely experience a relapse because there is currently no cure. 26 The refractory multiple myeloma is a disease which progresses within 60 days following the last treatment of the patient. 27,28 Recurrent cancer refers to the return of the disease after a period of initial, partial or complete remission. 29While some patients with multiple myeloma have absolutely no symptoms, the majority of them are diagnosed because of symptoms that may include bone problems, low blood counts, elevated calcium levels, kidney problems, or infections. . 30 Patients who relapse after treatment with standard therapies, including IP and immunomodulatory agents have a poor prognosis and have few treatment options available. 31

On March 25, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from the Afirma Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC) are associated with variants from three genes (Press release, Veracyte, MAR 25, 2019, View Source [SID1234534592]). The findings shed new light on the genomic underpinning of this rare, but aggressive, form of thyroid cancer and were presented today at ENDO 2019, the Endocrine Society’s annual meeting, which is being held March 23-26 in New Orleans.

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"Our findings are important because they help us better understand the genomic drivers of medullary thyroid cancer," said Steven G. Waguespack, M.D., professor of internal medicine and pediatrics at University of Texas MD Anderson Cancer Center in Houston, who presented the new data in a guided poster session. "Moreover, this information, derived from a fine needle aspiration biopsy specimen, may help guide physicians in the preoperative evaluation, surgical planning and targeted therapy selection for patients diagnosed with this disease."

For the study, researchers evaluated 77 preoperative fine needle aspiration biopsies from thyroid nodules that were positive for MTC based on Afirma testing and which spanned a range of Bethesda System cytology classification categories (III-VI). All cases were subsequently evaluated with the Xpression Atlas, which uses RNA whole-transcriptome sequencing to detect 761 variants and 130 fusions in 511 genes that are associated with thyroid cancer. The scientists found that among the MTC cases, 55.8 percent harbored a RET variant, 9.1 percent included a KRAS variant, 7.8 percent contained an HRAS variant (some of which contained more than one of these gene alterations), while 2.6 percent of cases possessed fusions and 26.0 percent included no gene variants or fusions.

"As more is understood about the genomic makeup of thyroid cancer biology, physicians may be able to further refine their treatment plans for patients using ever-more-granular genomic information," said Giulia C. Kennedy, Ph.D., chief medical and scientific officer at Veracyte. "We believe that our Afirma offering – based on our whole-transcriptome sequencing platform – is well-positioned to serve the needs of physicians in the expanding era of precision medicine."

On March 25, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that IMV Chief Executive Officer Frederic Ors will present at the Spring Investor Summit and the HC Wainwright Global Life Sciences Conference during April 2019 (Press release, IMV, MAR 25, 2019, IMV Inc. to Present at Two Upcoming Investor Conferences [SID1234534608]).

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Details on each conference and presentation are as follows:

Venue: Spring Investor Summit, being held April 1-2, 2019

Date of Presentation: Monday, April 1

Time: 8:30 a.m. ET

Location: JW Marriott Hotel, Essex House, New York City

Venue: HC Wainwright Global Life Sciences Conference, being held April 7-9, 2019

Date: Tuesday, April 9, 2019

Time: 10:40 a.m. BST

Location: Stratton Suite, Grosvenor House, A JW Marriott Hotel, London, UK

There will be a live webcast of both of these presentations available in the events, presentations and webcasts section of IMV’s website. Following the presentations, the webcasts will be archived for 90 days and a copy of the presentations will remain available in the same section of the website.