On June 4, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported positive interim data from the ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase 2b UNITY-NHL trial currently evaluating umbralisib as a single agent in patients with relapsed/refractory MZL (Press release, TG Therapeutics, JUN 4, 2019, View Source [SID1234536894]). Umbralisib is an investigational, oral, once-daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The interim data were presented today in an oral session during the 55th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The slides presented are available on the Company’s corporate website at www.tgtherapeutics.com/publications.cfm.

Summary of Data Presented:

The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported included safety and tolerability data on all 69 treated patients (safety population) and efficacy data on 42 patients who were enrolled at least 9 cycles (28 day cycles) prior to the data cut-off date (interim efficacy population). The primary endpoint is overall response rate (ORR) as assessed by IRC using criteria adopted from the International Working Group for malignant lymphoma.

Efficacy

Analysis of the interim efficacy population (n=42) with a median follow-up of 12.5 months showed the following:

Interim Efficacy Population (n=42)
Overall Response Rate by IRC (CR + PR), % 52%
Complete Response by IRC (CR), (%) 19%
Partial Response by IRC (PR), (%) 33%
Median duration of response, months NR (95% CI: 8.4 – NE)
CI = confidence interval; NR = not reached; NE = not estimable; SD = stable disease

Additional Efficacy Highlights:

52% ORR, with 17% CR, by IRC assessment for patients who had received 2 or more prior lines of therapy, n=23
88% clinical benefit rate by IRC, n=42, (defined as patients obtaining Complete Response + Partial Response + Stable Disease)
All patients achieving a Complete Response by IRC remain on study (range: 10.1+ to 15.7+ months)
Median time to initial response was 2.7 months
Kaplan-Meier (KM) estimate of progression-free survival (PFS) at 12 months was 66%, with the median PFS not reached
Safety

Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea, and fatigue, with the majority of events Grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively.

Key Safety Findings (n=69):

No events of colitis were reported and only 1 event of Grade 3 pneumonitis was reported
Grade 3 infections were limited, occurring in 3 patients (bronchitis, pneumonia, and influenza)
Discontinuations due to umbralisib-related AEs were limited (14%) with no discontinuations after 6 months due to a treatment-related AE
No deaths occurred on study
ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort
The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted when all treated patients have had at least 9 cycles (cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION
The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

On June 4, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from the pivotal phase III CLL14 study in previously untreated chronic lymphocytic leukaemia (CLL) showing that Venclexta/Venclyxto (venetoclax) plus Gazyva/Gazyvaro (obinutuzumab) met its primary endpoint of investigator-assessed progression-free survival (PFS) (Press release, Hoffmann-La Roche, JUN 4, 2019, View Source [SID1234536893]). The 12-month, fixed-duration, chemotherapy-free combination reduced the risk of disease worsening or death by 65% compared to Gazyva/Gazyvaro plus chlorambucil (PFS, as assessed by investigator; HR=0.35; 95% CI 0.23-0.53; p<0.001), when given to people with previously untreated CLL who have co-existing medical conditions. The results were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).1,2

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At two years, one year after stopping treatment, nearly nine out of ten patients (88.2%) in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm remained progression-free, compared to 64.1% in the Gazyva/Gazyvaro plus chlorambucil arm. Safety for Venclexta/Venclyxto plus Gazyva/Gazyvaro appeared consistent with the known safety profiles of the individual medicines. Common Grade 3-4 adverse events with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil, respectively, were low white blood cell count (52.8% vs. 48.1%) and infections (17.5% vs. 15.0%).

"The results of our phase III CLL14 trial, reported today at ASCO (Free ASCO Whitepaper) and in the New England Journal of Medicine, represent a major advance in improving outcomes in chronic lymphocytic leukaemia," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are pleased this fixed-duration, chemotherapy-free regimen of Venclexta/Venclyxto plus Gazyva/Gazyvaro was approved by the FDA and look forward to providing an important treatment option to even more adults with the most common form of adult leukaemia."

The treatment benefit demonstrated with the Venclexta/Venclyxto plus Gazyva/Gazyvaro combination compared to Gazyva/Gazyvaro plus chlorambucil was consistent across secondary endpoints, including:

Overall response (84.7% vs. 71.3%; p<0.001).
Complete response with at least partial blood count recovery (49.5% vs. 23.1%; p<0.001).
Minimal residual disease (MRD)-negativity in the bone marrow (56.9% vs. 17.1%; p<0.001) and peripheral blood (75.5% vs. 35.2%; p<0.001) three months after treatment. MRD-negativity means no cancer can be detected using a specific, highly sensitive test, and was defined as less than one CLL cell in 10,000 white blood cells.
These data were presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting on Tuesday 4 June 2019, at 10.09-10.21 CST (17.09-17.21, CET; abstract #7502), and simultaneously published in the NEJM.

The US Food and Drug Administration (FDA) approved the combination on 15 May 2019, under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes, for the treatment of people with previously untreated CLL or small lymphocytic lymphoma. This is the second regimen of Roche medicines approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Additional submissions of the CLL14 data to health authorities around the world are ongoing.

¨
Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie outside of the US.

About the CLL14 study2
CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil in patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. Co-existing medical conditions included reduced kidney function or co-morbidities assessed by a standard scale (Cumulative Illness Rating Scale). 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta/Venclyxto alongside six-month duration of Gazyva/Gazyvaro (Arm A) or six-month duration of Gazyva/Gazyvaro alongside 12-month duration of chlorambucil (Arm B). Arm A started with an initial dosing of Gazyva/Gazyvaro followed by a five-week Venclexta/Venclyxto dose ramp-up to help reduce the risk of tumour lysis syndrome. The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response rate (ORR), complete response (with or without complete blood count recovery), overall survival, duration of response, event-free survival, time to next CLL treatment, and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, MD, University of Cologne.

After a median follow-up of 28 months, results showed:

Patients who received Venclexta/Venclyxto plus Gazyva/Gazyvaro lived significantly longer without their disease worsening (PFS, as assessed by investigator) compared to those who received Gazyva/Gazyvaro plus chlorambucil (HR 0.35; 95% CI 0.23-0.53; p<0.001).
At two years, 88.2% of patients in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm had not experienced disease progression, compared to 64.1% with Gazyva/Gazyvaro plus chlorambucil.
Median PFS reported by investigators was not yet reached in either arm. IRC assessment of PFS was consistent (HR 0.33; 95% CI, 0.22- 0.51; p<0.001).
Clinical benefit observed for Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil was consistent across secondary endpoints, including ORR (84.7% vs. 71.3%; p<0.001) and CR including incomplete marrow recovery (49.5% vs. 23.1%; p<0.001).
In addition, higher rates of MRD-negativity in the bone marrow (56.9% vs. 17.1%; p<0.001) and peripheral blood (75.5% vs. 35.2%; p<0.001) were observed three months after treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil. MRD-negativity was defined as less than one CLL cell in 10,000 leukocytes.
Safety for Venclexta/Venclyxto plus Gazyva/Gazyvaro appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Common Grade 3-4 adverse events with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil, respectively, were low white blood cell count (52.8% vs. 48.1%) and infections (17.5% vs. 15.0%).
About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the Food and Drug Administration (FDA): in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; in combination with low-dose cytarabine (LDAC) for people with untreated AML ineligible for intensive chemotherapy, and in combination with Gazyva in people with previously untreated CLL and co-existing medical conditions.
Venclexta/Venclyxto is approved in more than 50 countries. Roche and AbbVie are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

About Gazyva/Gazyvaro (obinutuzumab)
Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B-cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About the German CLL Study Group (GCLLSG)
Founded in 1996 and headed by Michael Hallek, MD, the GCLLSG has been running various phase III, phase II and phase I trials in chronic lymphocytic leukaemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials, which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organisation supported by the German Cancer Aid (Deutsche Krebshilfe). www.dcllsg.de

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes polatuzumab vedotin, an anti-CD79b antibody drug conjugate; idasanutlin, a small molecule, which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, and Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On June 4, 2019 Cofactor Genomics, pioneers in the field of Predictive Immune Modeling, reported that they have become a member of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium with the goal of advancing the adoption of multidimensional biomarkers in cancer and immune-related diseases (Press release, Cofactor Genomics, JUN 4, 2019, View Source [SID1234536892]).
Formally launched in 2006, the FNIH Biomarkers Consortium is a major public-private biomedical research partnership managed by the FNIH with broad participation from stakeholders across biomedical research, including government, industry, academia and patient advocacy and other not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers of America, the Centers for Medicare & Medicaid Services (CMS) and BIO. The FNIH Biomarkers Consortium brings together the expertise and resources of various partners to rapidly identify, develop and seek qualification of potential high-impact biomarkers particularly to enable improvements in drug development, clinical care and regulatory decision-making.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Cofactor is pleased to be working together alongside the FNIH, NIH and FDA to accomplish our shared goals of improving predictive medicine through advanced biomarkers," said Cofactor CEO, Jarret Glasscock. "While other technologies stop at delivering data that require additional analysis or interpretation, we’re eager to see how Predictive Immune Modeling can fast track some of the valuable information these project teams have been seeking."

Cofactor’s success in demonstrating the utility of Predictive Immune Modeling with their ImmunoPrism assay positions them to add value to a number of the initiatives of the FNIH Biomarkers Consortium, specifically in the area of inflammation, immunity and cancer. Cofactor’s technical teams will participate in the FNIH Biomarkers Consortium and offer expertise in ImmunoPrism reagents and services to achieve advanced profiling of immune response.

"We are delighted to welcome Cofactor as the newest member of the FNIH Biomarkers Consortium and to further our work with their unique expertise in harnessing RNA data to drive multidimensional biomarker discovery," said Joseph P. Menetski, Ph.D., Associate Vice President for Research Partnerships, FNIH. "We could not accomplish our mission without the partnership of organizations like Cofactor that understand the importance of advancing biomarker research and its impact on precision medicine."

The FNIH Biomarkers Consortium is helping create a new era of precision medicine, with more highly predictive markers that have a direct impact on patients. Its goal is to combine the forces of the public and private sectors to accelerate the development of biomarker-based technologies, medicines and therapies for prevention, early detection, diagnosis and treatment of disease.

Cofactor’s Chief Scientific Officer, Jon Armstrong, will present on the power of Predictive Immune Modeling in the Translational Science & Emerging Biomarkers track at the IO Combinations 360° meeting to be held June 20-21 in Philadelphia. Clients and collaborators of Cofactor can register for the event at a 25% discount using code CFG25.

On JUne 4, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of updated results from a prospective, multicenter study demonstrating the accuracy and performance of DecisionDx-Melanoma at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from May 31-June 4 (Press release, Castle Biosciences, JUN 4, 2019, View Source [SID1234536891]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study titled, "Three year survival outcomes in a prospective cohort evaluating a prognostic 31 gene expression profile (31-GEP) test for cutaneous melanoma" (Abstract #9519), was presented at ASCO (Free ASCO Whitepaper) during the Poster Discussion Session: Melanoma/Skin Cancers. Previously an initial report of this cohort was published with a median follow-up of 1.5 years.

This second report, with a median follow-up of 3.2 years, emphasized three points of analysis:

Whether the study’s extended results demonstrate the accuracy of DecisionDx-Melanoma in predicting risk of recurrence, as previously reported.
Whether the prospective outcomes in patients with cutaneous melanoma tumors ≤2 mm thick (pathologic stage T1-T2) who had a low-risk DecisionDx-Melanoma Class 1A test result support the use of the test for guiding sentinel lymph node biopsy (SLNB) surgery decisions.
Overall, whether the study results show that DecisionDx-Melanoma can offer improvements in patient treatment beyond American Joint Committee on Cancer (AJCC) staging.
Key Study Findings

Patients with the highest risk DecisionDx-Melanoma result (Class 2B) had significantly reduced recurrence-free survival, distant metastasis-free survival and overall survival (OS) compared to patients with the lowest risk (Class 1A) result (p≤0.0001), consistent with three previously published prospective studies.
In the subgroup of patients with T1-T2 melanoma tumors, in which DecisionDx-Melanoma has been shown to predict sentinel lymph node status, Class 1A results were associated with favorable prognosis (OS=99.4%). This confirms the favorable prognosis in T1-T2 Class 1A melanomas reported in a long-term archival tissue study (5-year OS=98.2%) and provides support for the use of a Class 1A test result to identify patients at low risk for a positive SLNB surgery result and excellent prognosis who can avoid this surgical procedure.
DecisionDx-Melanoma Class 2B result was a significant, independent predictor of recurrence, distant metastasis and mortality compared to AJCC staging (Stages IIB-III; p<0.05) in multivariate regression analysis. Furthermore, the hazard ratio for OS was 9.35 for a high risk Class 2B result compared to 2.33 for AJCC high risk.
These prospective results demonstrate that DecisionDx-Melanoma is an accurate, independent predictor of outcomes, including in specific subgroups for whom the test has previously been shown to predict likelihood of recurrence and SLN positivity.
"A substantial proportion of melanoma-related deaths occur among patients who were traditionally staged as low risk, highlighting the importance of the improved risk prediction seen in this study," commented investigator Eddy C. Hsueh, M.D., Professor and Director, Division of General Surgery, St. Louis University Hospital. "Use of DecisionDx-Melanoma to improve outcome prediction over traditional staging alone can result in more informed treatment management decisions including appropriate use of sentinel lymph node biopsy, surveillance and follow-up."

Study Details:

Patients were prospectively enrolled in one of two clinical registries that were established to track patient outcomes and clinical utility. All patients underwent DecisionDx-Melanoma testing as part of their melanoma assessment.

The cohort included 342 patients with AJCC Stage I-III melanoma from 11 U.S. dermatologic and surgical centers with a median age of 58 years. The majority of patients (89%) had AJCC Stage I or II melanoma. Median Breslow thickness was 1.2 mm; 260 patients had tumors 2.0 mm thick or less (T1-T2). Median follow-up was 3.2 years for patients who did not experience an event.

The poster can be found in the Publications section of the Castle Biosciences website.

Additional Castle Biosciences Data at 2019 ASCO (Free ASCO Whitepaper)

Data demonstrating the economic impact of DecisionDx-Melanoma in Medicare-eligible patients were also presented as a poster at the 2019 ASCO (Free ASCO Whitepaper) meeting (Abstract #6630).

An economic model was developed to perform a cost-benefit analysis for use of the DecisionDx-Melanoma test to inform patient treatment decisions. Results from the economic model suggest that using the test to guide decisions regarding the SLNB surgery, completion lymph node dissection and surveillance for a Medicare-eligible population offers significant cost savings compared to traditional care. A net cost reduction is retained with addition of DecisionDx-Melanoma testing to guide surveillance decisions in Medicare-eligible patients with melanoma tumors greater than 2 mm thick (T3-T4). Combined with previously published data showing that patients ≥65 years with Class 1A, T1-T2 melanoma have low SLN positivity and favorable outcomes, the model can be used to determine the cost-benefit of using the DecisionDx-Melanoma test to guide SLNB decisions for Medicare-eligible patients.

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 June 4, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that Mr. Peter Greenleaf, Chief Executive Officer, will present a corporate overview at the following upcoming investor conferences (Press release, Aurinia Pharmaceuticals, JUN 4, 2019, View Source [SID1234536890]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies Healthcare Conference on Friday, June 7, 2019 at 9:30am PT (12:30pm ET) in New York, NY; and
Raymond James 2019 Life Sciences and MedTech Conference on Tuesday, June 18, 2019 at 5:35am (8:35am ET) in New York, NY.
All presentations will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of each presentation will also be archived on the Company website following the event.